Saturday, September 24, 2011

Dry eye drugs: Regenerx RGN259 completed Phase II

Results expected late October.

More details in news report.

ROCKVILLE, Md., Sep 23, 2011 (BUSINESS WIRE) -- RegeneRx Biopharmaceuticals, Inc. RGRX -3.13% ("the Company" or "RegeneRx") today announced that treatment and follow-up have been completed on 69 patients in the Company's Phase 2 clinical trial with RGN-259 for the treatment of dry eye syndrome, five more than the number of evaluable patients contemplated in the trial's protocol. After all study data completes the quality control process and data lock it will then undergo statistical analyses. The trial is on schedule for top-line results to be reported in late October.

This double-masked, placebo-controlled clinical trial will evaluate the safety and efficacy of RGN-259, the Company's proprietary preservative-free eye drops, in patients with dry eye syndrome. Patients received RGN-259 or placebo twice daily for 30 days. Signs and symptoms of dry eye, such as the degree of ocular surface damage, ocular itching, burning and grittiness, among others, was graded periodically during and following the treatment period. The trial is being conducted by Ora Inc., an ophthalmic contract research organization that specializes in dry eye research and clinical trials. Additional details regarding the Phase 2 trial are available at:

http://www.clinicaltrials.gov/ct2/show/NCT01387347?term=thymosin +beta+4&rank=5

Abstract: Mucin gene expression useful in diagnosing DES

I always think this area of DES research is not emphasized enough so it is nice to see this study.

OCULAR MUCIN GENE EXPRESSION LEVELS AS BIOMARKERS FOR THE DIAGNOSIS OF DRY EYE SYNDROME.

Purpose:
To evaluate mRNA levels of the ocular mucins MUC1, MUC2, MUC4, MUC5AC, and MUC7 in conjunctival impression cytology samples from patients with moderate to severe dry eye syndrome (DES) compared with a population of healthy subjects; and to investigate the use of the levels of these mucin genes as biomarkers of DES and subsequently as a potential diagnostic test for DES.

Methods:
This prospective study commenced in the year 2000 and ended in the year 2009. Thirty eight DES patients and 43 age- and gender-matched healthy subjects completed the initial part of the study. Investigations were repeated at a later stage in 16 healthy subjects and 30 DES patients, which were used as external validation data. Conjunctival impression cytology was performed in all subjects to test gene expression of ocular mucin genes MUC1, MUC2, MUC4, MUC5AC and MUC7. Statistical analysis was performed to determine if there was a difference in the levels of mucin gene expression between the two groups of subjects. Sensitivity and specificity of mucin gene expression for the diagnosis of the DES was calculated.

Results:
The expression of MUC1, MUC2, MUC4 and MUC5AC (P<0.0001) were significantly lower in conjunctival epithelium of patients with DES compared to normal subjects. These results were replicated in the external control subject and patient groups. MUC1 expression levels demonstrated the greatest sensitivity (83.3%) and specificity (87.5%) among all genes tested.

Conclusions:
Our data strongly suggest that the expression levels of MUC1 may be used as a diagnostic test in DES for investigational and selective clinical trials.


Invest Ophthalmol Vis Sci. 2011 Sep 19. [Epub ahead of print]
Corrales RM, Narayanan S, Fernández I, Mayo A, Galarreta DJ, Fuentes-Páez G, Chaves FJ, Herreras JM, Calonge M.
Source
CIBER-BBN (Networking Center for Biomedical Research-Biomaterials, Bioengineering, and Nanomedicine) in Valladolid; Carlos III Health Institute, Ministry of Science and Innovation, Spain.

Wednesday, September 21, 2011

Drug news: SAR 1118

Whoopie, we finally have an addition to the Phase III trial drugs!

SARcode Bioscience announced on Sept. 14 that enrollment is underway for a Phase 3 trial of SAR 1118 ophthalmic solution:

First Patient Enrolled in SARcode Bioscience's Pivotal Dry Eye Study of SAR 1118 Ophthalmic Solution

BRISBANE, Calif., Sept. 14, 2011 /PRNewswire via COMTEX/ -- SARcode Bioscience, Inc., a privately-held biopharmaceutical company, announced today that the initial patient has been enrolled in the company's pivotal Phase 3 clinical study (OPUS-1) of SAR 1118 ophthalmic solution.


SAR 1118 is a first-in-class molecule that inhibits T-cell inflammation by blocking the binding of two key cellular surface proteins (LFA-1 and ICAM-1) that mediate the chronic inflammatory cascade. SAR 1118 may be able to reduce inflammation associated with dry eye disease.

The OPUS-1 trial will study the safety and efficacy of SAR 1118 in the treatment of dry eye disease. Approximately 588 patients will be randomized to receive SAR 1118 5.0% ophthalmic solution or placebo twice daily over 12 weeks. The co-primary endpoints of the study are corneal fluorescein staining score and visual-related function score (reading, driving at night, computer use, and watching television) as measured by the Ocular Surface Disease Index (OSDI), a validated instrument designed to assess the impact of dry eye upon vision-related activities. The safety and tolerability of SAR 1118 compared to placebo at 12 weeks will also be evaluated.

Abstract: Dry eye in Japan

Prevalence and Risk Factors of Dry Eye Disease in Japan: Koumi Study.

OBJECTIVE:
To estimate the prevalence and risk factors of dry eye disease (DED) in a rural setting in Japan.

DESIGN:
Cross-sectional study.

PARTICIPANTS:
We included 3294 subjects, aged ≥40 years who were in the residential registry for Koumi town.

INTERVENTION:
Subjects in a rural mountain area, Koumi town, completed questionnaires designed to detect dry eye diagnosis and risk factors.

MAIN OUTCOME MEASURES:
Clinically diagnosed DED was defined as the presence of a previous clinical diagnosis of DED by ophthalmologists or severe symptoms of DED (both dryness and irritation constantly or often). Current symptoms of DED and possible risk factors such as age, gender, educational history, smoking history, alcohol drinking history, height and weight, visual display terminal (VDT) use, and contact lens (CL) wear, and past/current history of certain common systemic diseases were the main outcome measures. We used logistic regression analysis to examine associations between DED and other demographic factors.

RESULTS:
Of the 3294 eligible residents, 2791 residents (85%) completed the questionnaire. The percentage of women with a composite outcome of clinically diagnosed DED or severe symptoms (21.6%; 95% confidence interval [CI], 19.5-23.9) was higher than that of men (12.5%; 95% CI, 10.7-14.5; P<0.001). A low body mass index (BMI; odds ratio [OR], 2.07; 95% CI, 0.98-4.39), CL use (OR, 3.84; 95% CI, 1.46-10.10), and hypertension (HT) (OR, 1.39; 95% CI, 0.94-2.06) were risk factors for DED in men. Use of a VDT (OR, 2.33; 95% CI, 1.12-4.85), CL use (OR, 3.61; 95% CI, 2.13-6.10), and myocardial infarction or angina were the risk factors (OR, 2.64; 95% CI, 1.51-4.62), whereas high BMI was a preventive factor (OR, 0.69; 95% CI, 0.48-1.01) for DED in women.

CONCLUSIONS:
Among a Japanese cohort, DED leading to a clinical diagnosis or severe symptoms is prevalent. Use of CLs was a common dry eye risk factor in both genders. The condition is more prevalent in men with low BMI, HT, and in women with myocardial infarction or angina and VDT use. Relevant measures directed against the modifiable risks may provide a positive impact on public health and quality of life of Japanese.

FINANCIAL DISCLOSURE(S):
The authors have no proprietary or commercial interest in any materials discussed in this article.


Ophthalmology. 2011 Sep 1. [Epub ahead of print]
Uchino M, Nishiwaki Y, Michikawa T, Shirakawa K, Kuwahara E, Yamada M, Dogru M, Schaumberg DA, Kawakita T, Takebayashi T, Tsubota K.
Source
Department of Ophthalmology, School of Medicine, Keio University, Tokyo, Japan; Ryogoku Eye Clinic, Tokyo, Japan.

Abstract: Non-contact meibography

I kind of like the sound of this. Anything that can truthfully claim to be predictive of dry eye symptoms has something going for it.

Non-contact meibography: Keep it simple but effective.

PURPOSE:
Meibography is reported to be important in Meibomian Gland Dysfunction (MGD) evaluation. Our purpose was to investigate the usefulness of a standard infra-red video security camera in meibography.

METHODS:
Meibographs were taken of the right lower lid of 17 subjects (female 10; age=44.3years ±13.3 SD), randomly selected from the patient pool of Horst Riede GmbH, Weinheim, Germany. Meibomian glands (MG) were photographed by an near adapted infra-red video security camera and extend of MG loss (MGL) was measured by digital image analyzes. Lipid-layer and non-invasive break-up time (NIBUT) was measured by tearscope, dry eye symptoms were evaluated by the Ocular Surface Disease Index (OSDI). Correlations between MGL scores and ocular signs, tearfilm and symptoms were analyzed by Pearsons, differences between gender by U-test. The ability of MGL to predict dry eye symptoms was evaluated by area under the receiver operative characteristic curve (AUC).

RESULTS:
MGL scores were significantly correlated to lipid-layer pattern (r=-0.68, p=0.001) NIBUT (-0.46, 0.032) OSDI (0.89, 0.001) and age (0.61, 0.005). MGL was significantly larger in female (p=0.001). AUC of MGL was 95.8% (p=0.001; sensitivity=88.9%; specificity=87.5%; threshold=32.3%).

CONCLUSIONS:
MGL is a predictive test of dry eye symptoms. The analyzed significant correlation between MGL and tearfilm and dry eye symptoms indicates the usefulness of the non-contact IR meibograph (PNCM).


Cont Lens Anterior Eye. 2011 Aug 30. [Epub ahead of print]
Pult H, Riede-Pult BH.
Source
Optometry and Vision Research, Weinheim, Germany; Contact Lens & Anterior Eye Research Unit, School of Optometry & Vision Sciences, Cardiff University, UK.

Abstract: Contacts and computers (again)

Approximately one gajillion studies have been published to date showing the effects of any one or all of office air, computers and contact lenses for the ocular surface. Occasionally they're even somewhat interesting or informative.

The Impact of Contact Lens Wear and Visual Display Terminal Work on Ocular Surface and Tear Functions in Office Workers.

PURPOSE:
To evaluate the effect of contact lens (CL) wear and visual display terminal (VDT) work on the ocular surface and tear functions.

DESIGN:
Prospective case-control study.

METHODS:
Sixty-nine CL wearers (45 women and 24 men; mean age, 35.2 ± 7.3 years), and 102 age- and sex-matched non-CL wearers were enrolled in the study (66 women and 36 men; mean age, 36.7 ± 7.3 years). Ocular surface and tear function tests, including vital stainings (fluorescein and rose bengal), Schirmer test, tear meniscus height measurement, and tear film break-up time were performed. The subjective symptoms of dry eyes were evaluated using a dry eye symptom questionnaire. The participants were divided into 4 subgroups according to the total time of VDT work in 1 day (VDT work time in 1 day ≥ 4 hours or < 4 hours) and presence of CL wear. Main outcome measures included ocular surface vital staining scores, Schirmer test results, tear film break-up time, tear meniscus height measurement, and symptom questionnaire score.

RESULTS:
CL users and long-term VDT workers showed significantly worse tear meniscus height values than non-CL users and short-term VDT workers (P < .001). The mean visual symptom scores in CL wearers and long-term VDT workers were significantly higher than the other groups (P < .001).

CONCLUSIONS:
Office workers who wore CLs and spent more than 4 hours engaged in VDT work had a lower tear meniscus volume with significant dry eye and visual symptoms triggered by environmental factors.


Am J Ophthalmol. 2011 Aug 24. [Epub ahead of print]
Kojima T, Ibrahim OM, Wakamatsu T, Tsuyama A, Ogawa J, Matsumoto Y, Dogru M, Tsubota K.
Source
Johnson & Johnson Ocular Surface and Visual Optics Department, Keio University School of Medicine, Tokyo, Japan; Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan.

Diagnostics: Health Canada approves InflammaDry Detector

RPS Announces Health Canada Approval of RPS InflammaDry Detector™
(August 22, 2011)
Ten-minute test allows clinicians to detect inflammation in the tears of patients with Dry Eye disease


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Sarasota, FL (PRWEB) August 22, 2011

On August 11, Health Canada granted Rapid Pathogen Screening, Inc. a Medical Device License for the RPS InflammaDry Detector, the first and only rapid, in-office test to detect elevated levels of MMP-9 in tear fluid. Receiving a Medical Device License allows RPS to begin marketing the RPS InflammaDry Detector in Canada, following the product’s recent release in Europe and Asia. RPS anticipates that the RPS InflammaDry Detector will soon be available for sale in Canada through a reputable distribution partner.

Clinical signs of Dry Eye aren’t always directly related to patient complaints, making this disease difficult to diagnose. Additionally, inflammation is often present in Dry Eye patients long before the appearance of clinical signs. Matrix metalloproteinase-9 (MMP-9) is an inflammatory marker that has consistently been shown to be elevated in the tears of patients with Dry Eye disease. Elevated levels of MMP-9 correlate with clinical exam findings and research shows that MMP-9 may be a more sensitive marker than clinical signs when diagnosing Dry Eye. In addition, studies show that the diagnosis and treatment of elevated levels of MMP-9 prior to LASIK surgery may result in improved wound healing and reduced complications.

The RPS InflammaDry Detector requires only a small sample of human tears to detect elevated levels of MMP-9 and provides results in just 10 minutes. Similar to the company’s first product, the presence of a single blue control line indicates a negative test result and the appearance of both a blue control line and a red result line indicate a positive result. This in-office test can be performed on patients that present with signs and symptoms of Dry Eye or as part of pre-operative screening on patients having LASIK or cataract surgery. By using the RPS InflammaDry Detector, clinicians can make an accurate diagnosis and implement an appropriate treatment plan before patients leave the office.

“Receiving a Medical Device License from Health Canada for the RPS InflammaDry Detector is yet another exciting recent accomplishment for RPS,” says Dr. Robert Sambursky, president and chief medical officer of RPS. “Providing clinicians with a rapid and accurate in-office screening test to detect hidden Dry Eye disease will help identify patients that may benefit from perioperative therapy to improve their ocular surface, leading to better surgical and medical patient outcomes.”

The RPS InflammaDry Detector has a clinical sensitivity of 85% and a specificity of 94%. This level of accuracy allows the clinician to make an appropriate diagnosis and an informed treatment decision during the initial office visit. To learn more about the RPS InflammaDry Detector or other RPS products, visit http://www.rpsdetectors.com.

Abstract: Serum drops from SJS vs other dry eye patients

Interesting... in case any SJS patients were worried their blood might not be as good as the next person's for serum drops.

Stability of Epitheliotrophic Factors in Autologous Serum Eye Drops from Chronic Stevens-Johnson Syndrome Dry Eye Compared to Non-autoimmune Dry Eye.

Purpose:
To compare the concentrations of epitheliotrophic factors in autologous serum eye drops (ASE) prepared from sera of chronic Stevens-Johnson syndrome (SJS) patients with dry eyes to those prepared from non-autoimmune dry eye controls and to study the stability of the epitheliotrophic factors in different storage conditions.

Methods:
Twenty-percent ASE were prepared from 10 chronic SJS patients with dry eyes and 10 age-matched non-autoimmune dry eye controls. The concentrations of major epitheliotrophic factors comprising epidermal growth factor (EGF), transforming growth factor-beta1 (TGF-β1), transforming growth factor-beta2 (TGF-β2), and fibronectin in those ASE preparations were determined by enzyme-linked immunosorbent assay (ELISA) at baseline and after different storage conditions: at 4°C for 1 week and 1 month; and at -20°C for 1, 3 and 6 months.

Results:
There were no significant differences in the concentrations of EGF, TGF-β1, TGF-β2 and fibronectin in 20% ASE between the SJS and control groups (EGF: 176.9 ± 40.9 vs. 185.5 ± 36.9 pg/mL, TGF-β1: 9.5 ± 2.1 vs. 9.5 ± 1.9 ng/mL, TGF-β2: 55.3 ± 30.0 vs. 63.91 ± 45.6 pg/mL and fibronectin: 70.5 ± 20.2 vs. 62.2 ± 21.3 µg/mL, respectively). These factors were stable at 4°C for up to 1 month. Storage at -20°C for up to 6 months resulted in a slight decrease in TGF-β1 (SJS: from 9.5-8.4 ng/mL, p < 0.01 and control: from 9.5-8.1 ng/mL, p < 0.01).

Conclusions:
The results suggested that the epitheliotrophic capacity of ASE from chronic SJS should be comparable to those from non-autoimmune dry eye patients, and that ASE should be sufficiently stable for up to 6 months, if stored properly at -20°C.

Curr Eye Res. 2011 Sep;36(9):775-81.
Phasukkijwatana N, Lertrit P, Liammongkolkul S, Prabhasawat P.
Source
Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University , Bangkok , Thailand.

Abstract: Modified fluorescein strip in BUT measurements

A new modified fluorescein strip: Its repeatability and usefulness in tear film break-up time analysis.

PURPOSE:
To (i) analyze the repeatability of fluorescein instillation from a modified fluorescein strip (MFS) compared to a standard fluorescein strip (FS), and to (ii) observe its usefulness in the measurement of the fluorescein break-up time (FBUT) in comparison to the Tearscope (NIBUT).

METHODS:
In-vitro: Intra- and inter-observer repeatability in fluorescein instillation from the MFS and FS was evaluated by fluorescence analysis (n=10, each). In-vivo: BUT of the right eye of 20 randomly selected subjects (mean age 43.3±11.5, range=21-60 years, 8 males, 12 females) was measured by use of the Tearscope and MFS. Subjects were grouped by the Ocular Surface Disease Index (OSDI) score into 8 OSDI+ and 12 OSDI- by a cut-off value of 15.

RESULTS:
In-vitro: Intra-observer 95% limit of agreement (LoA) of the MFS was similar to the FS LoA in observer 1 (O1), but better than the FS LoA in observer (O2) (MFS: O1: LoA=±1.98mW; p=0.179; O2: ±2.71; 0.442; FS: O1: ±1.71; 0.246; O2: ±4.11; 0.512). Inter-observer LoA in fluorescence was better in MFS (±1.42; 0.111) than in FS (±3.71; 0.003). In-vivo: MFS-BUT was significantly shorter than the NIBUT (p=0.002), but significantly correlated (r=0.864, p<0.001). NIBUT and MFS-BUT were significant discriminators (p<0.001) of OSDI±(0.948/8s and 0.938/5s [AUC/cut-off value]; NIBUT and MFS-BUT, respectively).

CONCLUSIONS:
The MFS was better in the repeatability of fluorescein instillation than the FS. NIBUT and MFS-BUT were good discriminators of dry eye symptoms, but differ in their cut-off values.


Cont Lens Anterior Eye. 2011 Aug 16. [Epub ahead of print]
Pult H, Riede-Pult BH.
Source
Optometry and Vision Research, Weinheim, Germany; Contact Lens & Anterior Eye Research Unit (CLAER), School of Optometry and Vision Sciences, Cardiff University, UK.

Abstract: Oral azithromycin for posterior bleph

Unimpressive results. What do we care if some fraction of our numbers improve and we still feel lousy?

Oral azithromycin for treatment of posterior blepharitis.

PURPOSE:: To evaluate the effects of oral azithromycin in patients with posterior blepharitis.

METHODS:: Twenty-six eyes of 13 patients with posterior blepharitis diagnosed by a qualified ophthalmologist were enrolled in this study. Patients were instructed to use oral azithromycin 500 mg per day for 3 days in 3 cycles with 7-day intervals. Subjective clinical outcomes were graded and scored 1 day before and 30 days after the end of the treatment (53 days after initiating the treatment) based on severity scores of: (1) eyelid debris; (2) eyelid telangiectasia; (3) swelling of the eyelid margin; (4) redness of the eyelid margin; and (5) ocular mucus secretion. For the assessment of global efficacy, patients were asked by the investigator to rate the subjective symptoms (eyelid itching, ocular itching, eyelid hyperemia, ocular hyperemia, ocular mucus secretion, photophobia, foreign body sensation, and dry eye sensation) on a scale of 0 (no symptoms) to 5 (severe symptoms). Break-up time, Schirmer I test, corneal fluorescein staining score, and rose bengal staining score were also performed in all patients.

RESULTS:: All clinical outcomes scoring showed statistically significant improvement after oral azithromycin, except for eyelid swelling. Average subjective symptom grading improved statistically after treatment with oral azithromycin, except for eyelid hyperemia, photophobia, and foreign body sensation. Average tear film break-up time values showed statistically significant improvement after the treatment with oral azithromycin. No statistically significant improvement was observed on average values of Schirmer I test, corneal fluorescein staining score, and rose bengal staining score.

CONCLUSIONS:: The combination of multiple clinical parameters shown in this study supports the clinical efficacy of pulsed oral azithromycin therapy for the management of posterior blepharitis.



Cornea. 2011 Oct;30(10):1145-9.
Igami TZ, Holzchuh R, Osaki TH, Santo RM, Kara-Jose N, Hida RY.
Source
From the *Department of Ophthalmology, Hospital das Clínicas of Universidade de São Paulo (USP), Sao Paulo, Brazil; and †Department of Ophthalmology, Santa Casa de São Paulo, Sao Paulo, Brazil.

OTC: Tears Again advanced liposome spray

Based on past experience I feel like i need to add a disclaimer to this kind of post:

I am posting this NOT because I am personally recommending the product, but rather because there was a press release and there may be people among my readers (past users of liposome sprays?) who will be interested in knowing. One of my many goals with the websites and newsletter is to help people access products that are not widely known or are not available in every drugstore.

Tears Again® advanced Liposome Spray Now Available at CVS

ROSENBERG, Texas, Aug. 16, 2011 /PRNewswire/ -- OCuSOFT, Inc., an ophthalmic research, development, and supply company is pleased to announce that Tears Again® advanced Liposome Spray, an adjunct to OCuSOFT® Lid Scrub™ Eyelid Cleansers, is now available nationwide at all CVS drug stores.
Recent reports from the International Workshop on Meibomian Gland Dysfunction* (MGD) demonstrate an improvement of symptoms associated with Evaporative Dry Eye and Stage 2 MGD when a liposome spray, namely Tears Again® advanced Liposome Spray, was added to treatment plans. Compared with hyaluronate eye drops and triglyceride gels, the liposome spray was significantly more effective at reducing lid margin inflammation and improving tear film stability.
Utilizing patented liposome technology to deposit water and lipids as well as vitamins A, C, and E, Tears Again® advanced Liposome Spray provides moisture to soothe and relieve discomfort. Simply spray the cool, refreshing mist onto closed eyelids throughout the day as often as needed.
For a complete eyelid hygiene regimen, use Tears Again® advanced Liposome Spray in conjunction with OCuSOFT® Lid Scrub™ Eyelid Cleansers, which are also conveniently available at your local CVS.
For more information, visit www.tearsagainspray.com or call (800) 233-5469.
*Nichols KK, Foulks GN, Bron AJ, Glasgow BJ, Dogru M, Tsubota K, Lemp MA, Sullivan DA. The International Workshop on Meibomian Gland Dysfunction, Investigative Ophthalmology & Visual Science, Special Issue 2011, Vol. 52, No. 4

Drug development: RGN259 Phase II trial underway

Safety and Efficacy of Thymosin Beta 4 Ophthalmic Solution in Patients With Dry Eye (clinicaltrials.gov page)

Newsblurb from August 26

RegeneRx Biopharmaceuticals reported enrolling all 72 patients in its phase 2 trial of its RGN-259 treatment for dry-eye syndrome.

Patients will receive RGN-259 or a placebo twice daily until Sept. 23. The Rockville biotech expects preliminary data available in October.

In animal models, RGN-259 worked better than Restasis — the only FDA-approved drug for dry-eye syndrome — for certain conditions, according to a RegeneRx statement.

Abstract: Safety of re-using Refresh Plus vials

This is an interesting study that raises lots of questions about re-use of preservative free eyedrop vials.

There are many eyedrops in "single-use vials" which are common used by people with dry eye, from OTC preservative-free lubricants to Restasis. Most are so costly and entail so much waste if used only once that they are often re-used. Many doctors support such re-use and some manufacturers may as well. In the early days of Restasis I seem to recall they even provided a little contraption to store them safely for re-use. We see debates now and then on the bulletin board as to whether refrigeration is appropriate.

This study basically says that for a vial of Refresh Plus (pretty much the most commonly used artificial tear on the market), if the common bacterium pseudomonas aeruginosa gets in it, it will thrive and could do some nasty things to your cornea. Not good.

At the very least this sounds like a cautionary word for users of unpreserved carboxymethylcellulose-based artificial tears, i.e. if you're re-using them, you may want to reconsider. I would be interested to know of it has implications for other polymer-based unpreserved drops. This is certainly enough to make me reconsider whether I suggest to anyone that they carefully re-use vials.

Pseudomonas aeruginosa Growth in Refresh Plus(®).

Abstract Purpose:
To assess Pseudomonas aeruginosa growth in Refresh Plus(®), a unit-dose preservative-free ophthalmic solution indicated for the treatment of dry eye and after laser-assisted in situ keratomileusis (LASIK) surgery, which contains carboxymethylcellulose 0.5% as its active ingredient.

Methods:
Multiple test tubes of Refresh Plus were inoculated with 3 clinical ocular isolates of P. aeruginosa to achieve a target concentration of ∼100 colony-forming units (CFU)/mL. The tubes were incubated at 25°C and samples were aseptically removed at 6, 12, and 24 h. The samples were cultured to enumerate the population at each time point.

Results:
After 6 h incubation, the number of CFU/mL was 3,200 for isolate 1, 2,000 for isolate 2, and 6,480 CFU/mL for isolate 3. For all 3 organisms tested, the number of CFU/mL after 12 and 24 h incubation was >10(6) CFU/mL.

Conclusions:
Under the conditions of this experiment, Refresh Plus appears to support P. aeruginosa growth, suggesting that if the solution in a unit-dose vial of Refresh Plus were contaminated with P. aeruginosa during use, the organism would survive and replicate in the solution over time. Noncompliance with the manufacturer's recommendations (i.e., reuse of an open vial) may result in contamination of the solution with P. aeruginosa, which may cause severe keratitis.


J Ocul Pharmacol Ther. 2011 Aug 12. [Epub ahead of print]
Pinna A, Usai D, Zanetti S.
Source
1 Section of Ophthalmology, Department of Surgery, Microsurgery, and Medico-surgical Specialties, University of Sassari , Sassari, Italy .