Device news: TearLab osmolarity test making strides...

Medicare to Reimburse for TearLab Test
San Diego Business Journal
11 October 2010

San Diego-based TearLab Corp., which is developing therapies for dry eye disease, announced that the Committee for Medicare and Medicaid Services on Oct. 8 published a proposed reimbursement rate for the company’s osmolarity test. Starting in January, the government will reimburse doctors for the test at $24.01 per eye.

Reimbursement by CMS will only be available for doctor’s offices that have a moderate/complex clinical laboratory improvement amendments certificate until TearLab receives CLIA waiver categorization from the Food and Drug Administration. This waiver is currently under review by the FDA.

Osmolarity, or the measurement of salt content in a patient’s eyes, is the accepted standard for objectively diagnosing dry eye disease.

And while we're on the subject:

TearLab Announces Issuance of Core U.S. Patent
October 13 - Wall Street Journal

SAN DIEGO, Oct 13, 2010 (GlobeNewswire via COMTEX) -- TearLab Corporation (TEAR 2.85, -0.02, -0.70%) today announced that it has been granted U.S. Patent No. 7,810,380, entitled "Systems and methods for collecting tear film and measuring tear film osmolarity." This patent provides the company with broad and blocking intellectual property regarding the measurement of genetic and protein biomarkers within the tear film.

The patent, which will expire in 2029, allows TearLab to build upon its non-invasive tear collection platform to explore biomarkers across a wide range of disease states. This includes, but is not limited to, the Company's initial commercial target of Dry Eye Disease.

Abstract: Salivary gland transplantation

I'd like to know how many of the "10 eyes with cicatrizing conjunctivitis and a failed submandibular gland transplantation or no submandibular gland transplantation" were the former. And what "some ocular surface parameters" are. And how many of the patients would do it all over again.

This kind of surgery gives me the willies. I can't imagine why you would do something so invasive (and, apparently, risky) without first trying BOSP.

Long-Term Follow-up after Submandibular Gland Transplantation in Severe Dry Eyes Secondary to Cicatrizing Conjunctivitis.
Am J Ophthalmol. 2010 Oct 2. [Epub ahead of print]
Borrelli M, Schröder C, Dart JK, Collin JR, Sieg P, Cree IA, Matheson MA, Tiffany JM, Proctor G, van Best J, Hyde N, Geerling G.
Centro Grandi Apparecchiature, Seconda Universita degli Studi di Napoli, Napoli, Italy; Department of Ophthalmology, University of Würzburg, Würzburg, Germany.

PURPOSE: To evaluate the long-term results of autologous submandibular gland transplantation in eyes with cicatrizing conjunctivitis and to determine biomechanical and biochemical features of the resulting salivary tear film.

DESIGN: Prospective, observational case series.

METHODS: Fifteen eyes with cicatrizing conjunctivitis with a viable autologous submandibular gland transplantation were compared with 10 eyes with cicatrizing conjunctivitis and a failed submandibular gland transplantation or no submandibular gland transplantation. Best-corrected visual acuity, frequency of tear substitute instillation, severity of dry eye discomfort, lid margin erythema, conjunctival hyperemia, corneal epithelial edema, tear film break-up time, Schirmer test results, and corneal fluorescein and conjunctival Rose Bengal staining were evaluated. In a subgroup central corneal thickness and sensitivity, corneal epithelial barrier function, conjunctival and lid margin flora, and conjunctival impression cytologic analysis results were evaluated. In 3 patients, preoperative and postoperative tear samples were analyzed for viscosity, surface tension, and presence of mucins.

RESULTS: Submandibular gland autotransplantation resulted in long-term improvement of subjective, objective, and some ocular surface parameters. Salivary mucins were detectable in salivary tears after submandibular gland transplantation. The viscosity of salivary tears was more similar to normal saliva and the surface tension was intermediate between the 2 original secretions.

CONCLUSIONS: Submandibular gland autotransplantation provides long-term relief from pain and reduces the need for frequent installation of lubricants.

Abstract: Sensor for imaging tear film and lipid layer

Simultaneous examination of tear film break-up and the lipid layer of the human eye: A novel sensor design (Part 1).
Z Med Phys. 2010 Sep 28. [Epub ahead of print]
Arnold S, Walter A, Eppig T, Bruenner H, Langenbucher A.
Medical Optics at the Institute of Medical Physics, University of Erlangen-Nuremberg, Erlangen, Germany; Erlangen Graduate School in Advanced Optical Technologies (SAOT), University of Erlangen-Nuremberg, Erlangen, Germany.

This article presents a non-invasive sensor setup for objective analysis of the pre-corneal human tear-film involving a time-resolved videokeratoscopy and simultaneous imaging of the lipid layer of the tear-film by a second CMOS-camera. This paper describes in detail the mechanical and optical design of the sensor setup, the realization of the entire illumination component with an integrated Placido grid projection, and the calculation of the image formation using the Placido grid. This concept is demonstrated here with a test subject in the full inter-blink period. All images were taken under physiological conditions. The sensor can assist the ophthalmologist in diagnosing Dry-Eye Syndrome. Results and other potential applications are discussed.

Abstract: Long term dry eye outcomes with cGVHD

Tempting but difficult to assign any significance to positive results when you don't know what happened to 82% of the patients.

Long-term Clinical Course of Dry Eye in Patients With Chronic Graft-Versus-Host Disease Referred for Eye Examination.
Cornea. 2010 Sep 28. [Epub ahead of print]
Sáles CS, Johnston LJ, Ta CN.
From the Departments of *Ophthalmology; and †Medicine, Division of Blood and Marrow Transplantation, Stanford University Medical Center, Palo Alto, CA.

PURPOSE: To assess the long-term clinical course of dry eye in patients with chronic graft-versus-host disease (cGVHD).

METHODS: A prospective case series of 49 patients with cGVHD was conducted. Complete history and ophthalmic examination were performed at baseline and at 36 months (range, 26-53). All patients received treatment for dry eye.

RESULTS: Of the 49 participants, 18 (37%) had expired at the time of the 3-year eye examination, 11 were lost to follow-up, 11 declined or were unable to attend the final examination, and 9 (18%) completed the study. There was a statistically insignificant improvement in symptoms of dry eye assessed by the ocular surface disease index [start vs. endpoint: 36 ± 22 (range, 4-72) vs. 30 ± 27 (range, 4-86); P = 0.51]. Visual acuity remained stable at approximately 20/20. Lissamine green staining improved and Schirmer test (with anesthetic) worsened, but neither trend was statistically or clinically significant.

CONCLUSIONS: Stable visual acuity, tear production, and lissamine green staining and a statistically insignificant improvement in dry eye symptoms were observed in the 9 participants who completed this 3-year prospective case series of 49 patients with cGVHD. Insofar as these patients represent a minority (18%) of the original cohort, their clinical course may not be generalizable to all patients with cGVHD but may still suggest that this patient population's prognosis could be characterized by stability and excellent vision. Sufficiently powered prospective studies are required to validate these postulates.

Abstract: PF low-dose dexamethasone in chronic dry eye

Preservative-free low-dose dexamethasone for the treatment of chronic ocular surface disease refractory to standard therapy.
Cornea. 2010 Jul;29(7):723-6.
Jonisch J, Steiner A, Udell IJ.
From North Shore-Long Island Jewish Health System, Department of Ophthalmology, Great Neck, NY 11021, USA.

PURPOSE: To evaluate the short-term safety and efficacy of topical preservative-free dexamethasone 0.01% for the treatment of ocular surface disease and/or tearing refractory to conventional treatments.

METHODS: Retrospective chart review of all patients who received topical unpreserved dexamethasone 0.01% (Leiters Pharmacy, San Jose, CA). Follow-up visits were reviewed for subjective responses to the formulation and intraocular pressure. Responses were graded as significant/complete resolution of symptoms (50%-100% improvement), mild (25%-50% improvement), or no improvement.

RESULTS: Thirty-one patients received topical unpreserved dexamethasone 0.01% for the treatment of ocular surface disease. Follow up ranged from 4 to 60 months (average, 11.5 weeks). Twenty patients (65%) reported moderate or complete resolution of ocular symptoms. Seven patients (22%) had mild improvement in their symptoms. Four patients (13%) had no change in ocular symptoms. No patient in our series developed an elevation of intraocular pressure greater than 5 mm Hg above baseline intraocular pressure. No patient developed intraocular pressure greater than 22 mm Hg.

CONCLUSIONS: Topical nonpreserved 0.01% dexamethasone could be an effective therapy for recalcitrant chronic ocular surface disease.

Abstract: Non-invasive tear film surface assessment

Predicting Dry Eye Using Non-invasive Techniques of Tear Film Surface Assessment.
Invest Ophthalmol Vis Sci. 2010 Sep 29. [Epub ahead of print]
Szczesna DH, Alonso-Caneiro D, Iskander DR, Read SA, Collins M.
Institute of Physics, Wroclaw University of Technology, Wroclaw, Poland.

PURPOSE. To measure tear film surface quality in healthy and dry eye subjects using three non-invasive techniques of tear film quality assessment and to establish the ability of these non-invasive techniques to predict dry eye.

METHODS. Thirty four subjects participated in the study, and were classified as dry eye or normal, based on standard clinical assessments. Three non-invasive techniques were applied for measurement of tear film surface quality: dynamic-area high-speed videokeratoscopy (HSV), wavefront sensing (DWS) and lateral shearing interferometry (LSI). The measurements were performed in both natural blinking conditions (NBC) and in suppressed blinking conditions (SBC).

RESULTS. In order to investigate the capability of each method to discriminate dry eye subjects from normal subjects, the receiver operating curve (ROC) was calculated and then the area under the curve (AUC) was extracted. The best result was obtained for the LSI technique (AUC=0.80 in SBC and AUC=0.73 in NBC), which was followed by HSV (AUC=0.72 in SBC and AUC=0.71 in NBC). The best result for DWS was AUC=0.64 obtained for changes in vertical coma in suppressed blinking conditions, while for normal blinking conditions the results were poorer.

CONCLUSIONS. Non-invasive techniques of tear film surface assessment can be used for predicting dry eye and this can be achieved in natural blinking as well as suppressed blinking conditions. In this study, LSI showed the best detection performance, closely followed by the dynamic-area HSV. The wavefront sensing technique was less powerful, particularly in natural blinking conditions.

Abstract: BOL-303242-X

In Vivo Ocular Efficacy Profile of BOL-303242-X, a Novel Selective Glucocorticoid Receptor Agonist, In Rabbit Models of Ocular Disease.
Invest Ophthalmol Vis Sci. 2010 Sep 29. [Epub ahead of print]
Shafiee A, Bucolo C, Budzynski E, Ward KW, Lopez FJ.
Preclinical Pharmacology, Bausch & Lomb, Rochester, United States.

Purpose: To compare BOL-303242-X (formerly ZK-245186) efficacy, a novel Selective Glucocorticoid Receptor Agonist (SEGRA), to dexamethasone (DEX) in rabbit models of ocular disease. The effects of topical BOL-303242-X and DEX on intraocular pressure (IOP) and body weight changes were also evaluated.

Methods: Dry eye was induced by atropine sulfate administration, followed by treatment with saline, BOL-303242-X (0.1-1.0%), DEX (0.1%), Restasis® 0.05%, or Refresh Endura for 7-8 days. For paracentesis studies, vehicle, BOL-303242-X (0.1%, 0.5%, and 1.0%), or DEX (0.1%) were repeatedly administered topically 3 hours before paracentesis and continued for 90 min afterwards. For IOP and body weight measurements, right eyes of rabbits were topically treated with vehicle, BOL-303242-X (1.0% or 0.1%) or DEX (0.1%) four times per day for 6 weeks.

Results: In the dry eye model, BOL-303242-X and DEX were fully efficacious, maintaining tear volume and tear breakup time (TBUT) at baseline levels. Although Restasis improved tear volume versus vehicle, no changes were observed in TBUT. In the paracentesis study, BOL-303242-X and DEX improved ocular inflammation. BOL-303242-X reduced protein and PGE2 levels. Finally, BOL-303242-X showed no effects on integrated IOP or body weight, while DEX significantly increased integrated IOP and prevented the increase of body weight observed in the vehicle-treated animals.

Conclusions: BOL-303242-X shows full anti-inflammatory efficacy (similar to DEX) in experimental models of dry eye and post-operative inflammation, while demonstrating reduced effects in IOP and body weight. These data indicate that BOL-303242-X, a SEGRA, shows efficacy similar to traditional steroids, while exhibiting an improved side effect profile in IOP/muscle wasting.

Abstract: Tear collection methods for analysis

Two dimensional electrophoretic analysis of human tears: Collection method in dry eye syndrome.
Electrophoresis. 2010 Sep 29. [Epub ahead of print]
Saijyothi AV, Angayarkanni N, Syama C, Utpal T, Shweta A, Bhaskar S, Geetha IK, Vinay PS, Thennarasu M, Sivakumar RM, Prema P.
Biochemistry and Cell Biology Department, Vision Research Foundation, Sankara Nethralaya, Chennai, India.

Tear proteomics, by 2-DE, can give a fingerprint of the protein profile, which is well suited in clinical proteomics for biomarker identification and in diagnostics. The mode of tear collection can influence the representation of the proteins in the tear and therefore it is important to use the appropriate method. In this study, capillary and Schirmer mode of tear collection was done in the healthy controls and the Schirmer method was validated in dry eye syndrome conditions. 2-D PAGE of normal and dry eye tear was performed using pH 3-10 linear IPG strips followed by 13% SDS-PAGE. The spot intensity was analyzed by the PD quest software. The two methods were compared using Bland-Altman statistical tool. The 2-D map of capillary and Schirmer tear showed 147±8 spots and 145±7 spots respectively. Both the collection methods were in agreement with each other and were comparable. Dry eye tear protein showed differential expression of proteins as observed in 25-35 kDa region. One of the significantly reduced protein was identified as proline-rich 4 protein. Schirmer method of tear collection is reliable in patients with dry eye, which can display the differential protein expression and help in biomarker identification.

Abstract: Resolvin E1

Resolvin E1 Improves Tear Production and Decreases Inflammation in a Dry Eye Mouse Model.
J Ocul Pharmacol Ther. 2010 Sep 28. [Epub ahead of print]
Li N, He J, Schwartz CE, Gjorstrup P, Bazan HE.
1 Neuroscience Center of Excellence and the Department of Ophthalmology, Louisiana State University Health Sciences Center , New Orleans, Louisiana.

Purpose: Dry eye (DE) is a common ocular surface disease, particularly among women and the elderly, with chronic symptoms of eye irritation and, in severe cases, blurred vision. Several studies have shown that there is an inflammatory component in DE, although the pathogenesis is not thoroughly understood. Resolvin E1 (RvE1; RX-10001) is an endogenous mediator derived from the omega-3 polyunsaturated fatty acid eicosapentaenoic acid and is involved in inflammation resolution and tissue protection. Here we investigated the role of RvE1 in a DE mouse model.

Methods: Thirteen- to 14-week-old female BALB/C mice were exposed to desiccating conditions. One week after DE exposure, animals were treated topically with drug or vehicle 4 times per day for an additional week. Controls were nontreated animals placed in a normal environment. Schirmer's test was performed before treatment initiation and at days 2 and 4 after treatment. Density of corneal epithelial cells was analyzed in vivo using the Rostock Cornea Module of the Heidelberg Retina Tomograph (HRT-II). Corneas were processed using Western blot analysis and immunofluorescence examination.

Results: Schirmer's test showed a significant decrease in tear production in DE compared with controls. There was no change at 2 and 4 days after treatment with the vehicle, but a significant increase was observed at 2 and 4 days in the RvE1-treated group. The density of the superficial epithelial cells showed a significant decrease after DE compared with controls, which increased after 7 days of RvE1 treatment. Western blot analysis showed that α-smooth muscle actin and cyclooxygenase-2 (COX-2) expression were strongly upregulated after DE and decreased after 7 days of RvE1 treatment. Immunofluorescence confirmed strong positive staining of α-smooth muscle actin and COX-2 in stroma and/or in epithelia after DE, which decreased with RvE1 treatment. The percentage of infiltrating CD4⁺ T cells and CD11b⁺ cells decreased after RvE1 treatment when compared with DE.

Conclusion: RvE1 promotes tear production, corneal epithelial integrity, and a decrease in inflammatory inducible COX-2. In the stroma, RvE1 inhibits keratocyte transformation to myofibroblasts and lowers the number of monocytes/macrophages in this DE mouse model. These results suggest that RvE1 and similar resolvin analogs have therapeutic potential in the treatment of DE.

Abstract: Artificial tears and glaucoma meds

Hm.

Wish the abstract mentioned whether both the beta blocker and the prostoglandin were BAK-preserved.

Effects of osmoprotection on symptoms, ocular surface damage, and tear film modifications caused by glaucoma therapy.
Eur J Ophthalmol. 2010 Sep 24. pii: E93E767B-C4CE-4EA0-900B-A253B96FACB2. [Epub ahead of print]
Monaco G, Cacioppo V, Consonni D, Troiano P.
Ophthalmology Unit, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milan - Italy.

Purpose.
To determine the effects of 2 artificial tear formulas on the ocular surface in patients with glaucoma using topical preserved beta-blockers (BB) or prostaglandins (PG).

Methods.
This was a prospective, comparative, randomized, double-blind study with a crossover design. Twenty patients with dry eye were divided into 2 groups based on glaucoma treatment: BB (10 subjects) or PG (10 subjects). Each group was administered a 4-week course of unpreserved isotonic (300 mOsm/L) solution containing 0.2% sodium hyaluronate (SH) or a preserved isotonic (295-305 mOsm/L) solution containing 0.5% carboxymethylcellulose and 0.9% glycerin as compatible solute (CMCs) administered QID. After a 2-week washout period, the course of treatment was reversed. The primary efficacy criteria consisted of assessing symptoms according to the Ocular Surface Disease Index© (OSDI); the secondary efficacy criteria consisted of evaluating tear film confocal microscopy, central corneal thickness (CCT), and lissamine corneal and conjunctival staining (Oxford Grading System Score [OGSS]).

Results.
Within each group, only CMCs induced a significant improvement in OSDI and OGSS compared to baseline values: OSDI -20.5, p<0.0001; OGSS -0.9, p<0.0001. Tear film confocal microscopy improved after treatment, especially in case of patients who were administered CMCs. No difference in CCT was noticed for any subject.

Conclusions.
This study demonstrates for the first time that the use of concomitant CMCs in the management of glaucoma undergoing treatment with BB or PG may assist in tear film production and could lead to better compliance with intraocular pressure-lowering medication and ultimately better prognosis.

Abstract: Lacrisert

Correlating Patient-Reported Response to Hydroxypropyl Cellulose Ophthalmic Insert (LACRISERT(®)) Therapy with Clinical Outcomes: Tools for Predicting Response.
Curr Eye Res. 2010 Oct;35(10):880-887.
McDonald M, D'Aversa G, Perry HD, Wittpenn JR, Nelinson DS.

Ophthalmic Consultants of Long Island, Lynbrook, New York.
Abstract

Background/Aims:
To determine whether patient-reported improvement in symptoms of dry eye syndrome, activities of daily living, and other quality-of-life measures after treatment with hydroxypropyl cellulose ophthalmic inserts correlates significantly with physician assessment of clinical outcomes.

Methods:
Patient registry of those treated for 1 month with inserts as monotherapy or in combination with existing treatments for moderate-to-severe dry eye syndrome. A total of 520 participants were enrolled. Of those, 418 patients completed the study. Results of this registry were evaluated and correlations were calculated to determine whether patient-reported symptoms, quality of life, and changes in disease severity based on the Ocular Surface Disease Index, and activities of daily living outcomes are predictive of physician assessment of clinical signs, symptoms, and adherence to therapy.

Results:
Most patients reported overall improvement in their condition. Patient-reported improvements in the symptoms of dry eye syndrome and activities of daily living were significant predictors of physician assessment of compliance with insert therapy, improvement in symptoms and clinical signs, effectiveness of therapy, and acceptance of use as adjunctive therapy.

Conclusions:
Patient-reported symptoms and activities of daily living are predictors of patient compliance and treatment success with the use of inserts, as reported by treating physicians. The benefits were additive to the standard of care that was continued during the course of the study. These predictors, along with clinical diagnostic tests, can be used by eye care professionals to assess the efficacy of treatment for moderate-to-severe dry eye syndrome quickly and reliably.

Abstract: Using a confocal to diagnose Demodex

In vivo evaluation of Ocular Demodicosis using Laser Scanning Confocal Microscopy.
Invest Ophthalmol Vis Sci. 2010 Sep 16. [Epub ahead of print]
Kojima T, Ishida R, Sato EA, Kawakita T, Ibrahim OM, Matsumoto Y, Kaido M, Dogru M, Tsubota K.
Keio University School of Medicine, J&J Ocular Surface and Visual Optics, Tokyo, Japan.

Purpose:
To investigate the applicability of in vivo laser scanning confocal microscopy in the diagnosis and follow up of ocular demodicosis infestation in a prospective controlled study

Methods:
Fifteen right eyes of 15 patients with blepharitis associated with cylindrical dandruff (10 males, 5 males; mean age: 62.9±9 years) and 8 right eyes of 8 age and sex matched control subjects underwent HRTII/ RCM, evaluation of ocular symptom scores, tear function tests including vital stainings, Schirmer test, tear clearance test and evaluation of mite numbers in the eye lids.
Results:
In vivo confocal microscopy effectively disclosed the mites in the terminal bulbs of the eyelashes which were not observed after treatment. Eyelids with Demodicosis infestation showed marked inflammatory infiltrates around the meibomian glands and conjunctiva which cleared with tea tree oil treatment.

Conclusion:
Laser scanning confocal microscopy seems to be an efficient non-invasive tool in the diagnosis and follow up of ocular demodicosis infestation.

Abstract: GvHD and the eyes

Phew.

I hope that the "possible strategies" for ocular GvHD discussed in the full article had the BOSP at the top of the list. I think it is unconscionable to fail to educate GvHD patients on the potential of this treatment, given how serious the complications can be for the eyes when other treatments fail.

Ocular Involvement in Chronic Graft-Versus-Host Disease: Therapeutic Approaches to Complicated Courses.
Cornea. 2010 Sep 15. [Epub ahead of print]
Koch KR, Joussen AM, Huber KK.
From the Department of Ophthalmology, University of Duesseldorf, Duesseldorf, Germany.

Chronic graft-versus-host disease (cGvHD) is a major concomitant phenomenon in recipients of allogeneic hematopoietic stem cell transplantations, affecting multiple organ systems including the eye. Ocular structures, such as lacrimal gland, conjunctiva, and eyelids with meibomian glands, are frequently involved with clinical features ranging from dry eyes and common inflammatory conjunctival disease to severe complications like corneal ulcerations or even perforations. We present 2 patients with complicated courses of ocular cGvHD. In both cases, keratoconjunctivitis sicca refractory to systemic immunosuppressive therapy and to conventional topical treatment resulted in progressive binocular corneal melting and finally repeated perforations. According to our 2 cases and to the current pathophysiological understanding, we discuss possible strategies for the treatment and prevention of ocular cGvHD complications.

Abstract: Report from Lacrisert patient registry

Efficacy of Hydroxypropyl Cellulose Ophthalmic Inserts (LACRISERT) in Subsets of Patients With Dry Eye Syndrome: Findings From a Patient Registry.
Cornea. 2010 Sep 15. [Epub ahead of print]
Luchs JI, Nelinson DS, Macy JI; for the LAC-07-01 Study Group.
From the *South Shore Eye Care, Wantagh, NY; †InterQuest Medical and Scientific, LLC, Parsippany, NJ; and ‡Macy Eye Center, Los Angeles, CA.

PURPOSE: To determine acceptability and efficacy of hydroxypropyl cellulose ophthalmic inserts in patients with dry eye syndrome (DES) and additional comorbidities.

DESIGN: A multicenter, 2-visit, open-label, 4-week registry study.

PARTICIPANTS: Five hundred twenty patients were recruited to the intent-to-treat group. Four hundred eighteen patients completed the study including 86 contact lens wearers, 79 with cataract diagnosis, 52 with prior cataract surgery, 22 with prior laser-assisted in situ keratomileusis, and 15 with glaucoma.

METHODS: Patient questionnaires were completed at baseline and after 4 weeks of treatment to assess mean change in severity of DES symptoms, ocular surface disease index (OSDI) scores, frequency of occurrence of DES symptoms, occurrence of difficulty when performing activities of daily living (ADLs), and frequency of discomfort in various environmental conditions. Mean change was measured from visit 1 to visit 2.

MAIN OUTCOME MEASURES: Symptoms, OSDI scores, and measure of degree of difficulty when performing ADLs.

RESULTS: Four hundred eighteen patients completed the study. Compared with baseline, this population of patients demonstrated statistically significant improvements in mean OSDI scores (P = 0.0215) and symptoms of discomfort, burning, dryness, grittiness, stinging, and light sensitivity (P < 0.05). Mean improvement in OSDI scores of patients in the 5 identified subsets of patients with comorbid conditions were significant for patients using contact lenses (P < 0.025), who had undergone prior cataract surgery (P < 0.04), and with prior laser-assisted in situ keratomileusis surgery (P < 0.05). Patients diagnosed with cataracts or glaucoma did not show significant changes in any measures in this study. Patients with DES and comorbid conditions experienced relief of symptoms and benefit to ADLs and quality of life similar to patients without comorbid conditions.

CONCLUSIONS: In subsets of patients with moderate to severe DES and comorbid conditions, hydroxypropyl cellulose ophthalmic inserts improve the symptoms of DES, ability to perform ADLs, and quality of life. The reported benefits may be additive to those seen with patients' existing therapies.

Abstract: How often MGD (and other stuff) coincide with DE

The Association of Meibomian Gland Dysfunction and Other Common Ocular Diseases With Dry Eye: A Population-Based Study in Spain.
Cornea. 2010 Sep 15. [Epub ahead of print]
Viso E, Gude F, Rodríguez-Ares MT.
From the *Department of Ophthalmology, Complexo Hospitalario de Pontevedra, Pontevedra, Spain; †Clinical Epidemiology Unit and ‡Department of Ophthalmology, Hospital Clínico Universitario de Santiago; and §Department of Ophthalmology, University of Santiago de Compostela and Instituto de Investigaciones Sanitarias de Santiago, Santiago de Compostela, Spain.

PURPOSE: To investigate the relationship of meibomian gland dysfunction (MGD) and other prevalent ocular diseases with dry eye (DE) in a general adult population.

METHODS: An age-stratified random sample of 1155 subjects aged ≥40 years was selected in O Salnés, Spain. From 937 eligible subjects, 654 (69.8%) participated (mean age (SD): 63.6 (14.4) years; range: 40-96; and 37.2% males). A standardized DE questionnaire was administered. Objective evaluation included the Schirmer test, tear film breakup time (TBUT), fluorescein staining, and rose bengal staining. DE was defined as the simultaneous presence of symptoms and at least one sign. The relationship of MGD and other ocular diseases with DE was investigated. A design-based analysis was performed, and all calculations were weighted to give unbiased estimates.

RESULTS: DE and MGD prevalence were 11.0% [95% confidence interval (CI), 8.6-13.3] and 30.5% (95% CI, 26.9-34.1), respectively. MGD was present in 45.8% (95% CI, 34.8-57.2) of subjects with DE and was associated, after controlling for age and sex, with DE [adjusted odds ratios (ORa), 1.81]; with symptoms (ORa, 2.26); and with TBUT (ORa, 1.97), fluorescein staining (ORa, 2.09) and rose bengal staining (ORa, 3.25). The remaining ocular diseases were not associated with symptoms. However, pterygium was significantly associated with fluorescein staining (ORa, 1.89); cataract surgery with TBUT (ORa, 2.79); trauma and pseudoexfoliation with rose bengal staining (ORa, 2.75 and ORa, 4.04); and glaucoma with TBUT (ORa, 3.26), fluorescein staining (ORa, 3.40), and rose bengal staining (ORa, 3.46).

CONCLUSIONS: DE and MGD are common diseases in this population. MGD is strongly associated with symptoms and signs of DE. Nearly half of the subjects with DE have MGD. Pterygium, trauma, cataract surgery, pseudoexfoliation, and glaucoma are associated with signs of DE.