Friday, February 4, 2011

Product recall: Soothe Xtra Hydration

Voluntary Recall of Soothe® Xtra Hydration (XH) Eye Drops


FOR RELEASE WEDNESDAY, JANUARY 19, 2011

MADISON, N.J. -- Bausch + Lomb, the global eye health company, is conducting a voluntary recall of its Soothe® Xtra Hydration (XH) eye drops, only available within the United States.

Bausch + Lomb chose to initiate this recall based on a small number of consumer reports citing the presence of possible foreign matter in the tip of the bottles. Initial testing by Bausch + Lomb on the opened, partially-used product has identified the particles as mold.

Bausch + Lomb has chosen to voluntarily recall all existing lots of the Soothe® Xtra Hydration (XH) eye drops in the interest of patient safety. After the bottle is opened, eye drops which may become contaminated may also cause eye infections, as such the Company is taking this voluntary action to protect our consumers.

Bausch + Lomb has alerted the U.S. Food and Drug Administration of this voluntary recall.

Bausch + Lomb is currently conducting an ongoing investigation into the reports of mold in the tip of the bottles. A determination of future product distribution will be made at the close of this investigation which could last several months.

Soothe® Xtra Hydration (XH) eye drops have been available since April 2010 in the U.S. only. Approximately 1.3 million bottles have been distributed in the United States.

The voluntary recall is limited only to the United States; it does not affect locations in Europe, the Middle East or Asia-Pacific regions. The Soothe® Xtra Hydration (XH) eye drops are the only eye drops affected in this recall; all other Soothe® eye products remain on the market.

Bausch + Lomb has directly contacted U.S. retailers who have been shipped this product to initiate the recall and inform them of the steps they should take to return the product to us. The Company has also contacted eye care professionals to alert them of the recall.

The Company is asking consumers who currently have Soothe® Xtra Hydration (XH) eye drops to return the product to Bausch + Lomb. Even if consumers are comfortable using the eye drops, we urge them to return the product.

Consumers who have this product in their home should call one of the following numbers for instructions on returns and reimbursement:

Soothe® Xtra Hydration (XH) Recall Hotline: 1-877-907-9964
Bausch + Lomb customer service center: 1-800-553-5340


Bausch + Lomb’s customer service line is open to consumers 9 a.m.-5 p.m. EST Monday through Friday.

RECALLED PRODUCT DETAILS:

Lot Numbers:

GC0124, GD0146, GF0121, GF0157, GJ0023, GK0044, GC0135, GC0142, GE0049, GE0050/GE0074, GF0063, GF0064/GF0065, GF0021, GG0035, GG0036, GG0055, GJ0003, GJ0004

UPC Code:

310119022337

Case Codes:

10310119022334 (15ml size)
10310119022341 (accessory kits of 3ml size)

Expiration Dates:

09/2011, 10/2011, 12/2011, 05/2012, 04/2012
03/2011, 05/2011, 06/2011, 07/2011

Packaging and Dosage:

The product is packaged in a single, sterile 0.5 FL OZ (15ml) bottle. There are 3 ml sample bottles for physicians. It is dosed as 1 to 2 drops per affected eye(s) as needed or directed by your physician.

Thursday, February 3, 2011

Abstract: OCT, LIPCOF and DE

Any more acronyms anyone?

Imaging lid-parallel conjunctival folds with OCT and comparing its grading with the slit lamp classification in dry eye patients and normal subjects.

Purpose:
to visualize and describe the morphological appearance of lid-parallel conjunctival folds (LIPCOF) using optical coherence tomography (OCT) and to relate it to dry eye signs and symptoms.

Methods:
LIPCOF grade, non-invasive tear film break-up time (NIBUT), lipid layer's interference pattern and dry eye symptoms were recorded in 17 normal and 33 dry eye cases. LIPCOF was evaluated with slit lamp and visualized with OCT. Three different algorithms for OCT was developed to grade LIPCOF using either tear meniscus height or the covering tear film on the folds evaluated by OCT.

Results:
The three OCT methods showed significant correlations with the slit lamp method (r=0.470--0.473, P<0.01). The OCT LIPCOF methods were independent of NIBUT. The Dry Eye Questionnaire (DEQ) scores correlated with the height of the folds, and the absence of tear film coverage of the folds (r=0.574, P<0.001, and r=-0.527, P<0.001, respectively). The OCT LIPCOF grades correlated with the DEQ scores (r=0.494, P<0.001 and r=0.310, P=0.029). The slit lamp grade did not correlate with the DEQ scores in the whole population, but in the normal group (r=0.458, P=0.024). The OCT LIPCOF grades showed inverse correlation with lipid pattern in the normal group (r=-0.422-0.481, P=0.05), however this association disappeared in the dry eye group.

Conclusions:
The OCT enabled a non-invasive high resolution method for imaging, evaluating and grading of the LIPCOF. These novel classifications correlated well with the slit lamp grade and the DEQ scores promising a new, more objective evaluation of dry eye.


Invest Ophthalmol Vis Sci. 2011 Jan 31. [Epub ahead of print]
Veres A, Tapaszto B, Kosina-Hagyó K, Somfai GM, Németh J.
Department of Ophthalmology, Semmelweis University, Budapest, Hungary.

Abstract: Estradiol-drospirenone effect on dry eye

Improvement to OSDI, TBUT and Schirmer after oral hormone drug.

Effects of estradiol-drospirenone on ocular and nasal functions in postmenopausal women.

Background 
Hormones may have an impact on the incidence and course of dry-eye syndrome, and also nasal obstruction, especially in postmenopausal women. The aim of this study was to investigate the effects of drospirenone 2 mg + estradiol 1 mg (Angeliq®, Bayer AG, Berlin, Germany) on ocular functions and nasal airflow in postmenopausal women.

Methods Thirty-four postmenopausal women were recruited for the study. A questionnaire on ocular surface disease index (OSDI) was administered; after routine ophthalmologic examination, tear film break-up time (TBUT) and Schirmer tests were performed. Intraocular pressure was measured with a Goldmann applanation tonometer. Nasal airflow resistance values were measured using rhinomanometry. Participants were submitted to oral daily treatment with drospirenone 2 mg + estradiol 1 mg. The duration of the study was 6 months and the participants were studied in the basal condition and after 6 months of therapy.

Results The OSDI score and intraocular pressure were significantly higher before treatment than after treatment (p < 0.001); however, the results of the TBUT and Schimer test were significantly lower (p < 0.05). Rhinomanometric values were better during drospirenone 2 mg + estradiol 1 mg therapy than those observed at baseline (p < 0.001).

Conclusions Oral daily treatment with drospirenone 2 mg + estradiol 1 mg reduces the risks for ocular diseases and nasal obstruction in postmenopausal women.



Climacteric. 2011 Feb 1. [Epub ahead of print]
Coksuer H, Ozcura F, Oghan F, Haliloglu B, Coksuer C.
Departments of * Obstetrics and Gynecology.

Abstract: Lipiflow

(Well, the abstract doesn't say so, but that's what it is.)

A novel thermodynamic treatment for meibomian gland dysfunction.

Purpose:
To evaluate a novel thermodynamic treatment for obstructive meibomian gland dysfunction (MGD).

Materials and Methods:
Fourteen adult subjects (10 females, 4 males, mean age = 54.2 ± 9.6 yr) were recruited in a multi-center, feasibility clinical trial in Durham and Cary, North Carolina and Boston, Massachusetts. Inclusion criteria included: previous diagnosis of moderate to severe dry eye; dry eye symptoms for at least three months prior; daily topical lubricant use; and evidence of meibomian gland (MG) obstruction in the central five glands of both eyes lower eyelids. Exclusion criteria included: history of recent acute or chronic ocular inflammation or infection and lid surface abnormalities affecting lid function. The treatment: the device heats the palpebral surface of upper and lower eyelids while simultaneously applying graded pulsatile pressure to the outer eyelid for 12 min, thereby expressing the MGs during heating. One eye was randomly selected to undergo additional manual heated expression with another treatment device.

Results:
The mean MG secretion score, tear break-up time, corneal staining score, number of MGs yielding liquid secretion and symptom scores all improved significantly from baseline to 1 week. This was maintained through the 3-month follow-up. There was no statistically significant difference in any outcome between the automated device treatment only and the additional heated manual expression.

Conclusion:
The combination of heat applied to the palpebral surface, while simultaneously expressing MGs during a single 12-minute treatment, was effective, in this feasibility study, in treating obstructive MG dysfunction and dry eye signs and symptoms for the 3-month study period.



Curr Eye Res. 2011 Feb;36(2):79-87.
Friedland BR, Fleming CP, Blackie CA, Korb DR.
TearScience, Inc., Morrisville, North Carolina, USA.

Abstract: Inducing dry eye with BAK (for a dry eye model)

A mouse dry eye model induced by topical administration of benzalkonium chloride.

PURPOSE: To develop a dry eye model of mouse induced by topical administration of benzalkonium chloride (BAC) and investigate the possible mechanisms.

METHODS: BAC at concentration of 0.2% was applied to the mouse ocular surface for 7 days. Phenol red thread tear test, tear break-up time (BUT) test, corneal inflammatory index scoring, fluorescein and rose bengal test were performed to evaluate the toxic effects of BAC on the ocular surface. Global specimens were collected on day (D) 7 and labeled with a series of antibodies including cytokeratin 10 (K10) and mucin 5AC (MUC5AC). Apoptosis of ocular surface epithelium was evaluated by in situ terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay. Histologic analysis and transmission electron microscopy (TEM) were performed on D7.

RESULTS: BAC at a concentration of 0.2% successfully induced a dry eye condition with decreased tear volume and BUTs, increased corneal fluorescein and rose bengal scores. The Inflammatory index was increased in accompanyment with higher tumor necrosis factor-α (TNF-α) expression and more inflammatory infiltration in the cornea. Immunolabeling revealed positive K10 expression in BAC-treated corneal epithelium and fewer MUC5AC-positive cells in the BAC-treated conjunctival fornix. TUNEL assay showed more apoptotic cells in the corneal basal epithelium. TEM showed that the size and intervals of the microvillis were both reduced in the corneal epithelium.

CONCLUSIONS: Topical administration of 0.2% BAC in mouse induces changes resembling that of dry eye syndrome in humans, and thus, represents a novel model of dry eye.


Mol Vis. 2011 Jan 25;17:257-64.
Lin Z, Liu X, Zhou T, Wang Y, Bai L, He H, Liu Z.

Abstract: More demodex and blepharitis

[Demodex-related marginal blepharitis in Japan].

PURPOSE: Some marginal blepharitis is related to demodex, but this has not yet been reported in Japan. In this study, patients with severe marginal blepharitis with cylindrical dandruff were studied to examine the number of demodex in their cilia.

METHODS: Ten eyes of 10 patients (7 men and 3 women, mean age: 62.9 +/- 9.0 years) with unilateral marginal blepharitis which had cylindrical dandruff in their cilia were studied. Three cilia which had the most cylindrical dandruff were removed from the eyelids for microscopic examination. After cleaning the eyelid margins for 1 week, the examination was repeated. Scoring of itching and foreign body sensation of the patients was performed both before and after the treatment.

RESULTS: Demodex folliculorum was detected in the cilia of 8 out of 10 eyes (80%), and 22 cilia out of 30 with cylindrical dandruff. The average number of demodex/cilia was 1.6 +/- 0.9. In all cases, the number of demodex/cillium decreased significantly with the improvement in symptoms and blepharitis.

CONCLUSION: An Increase in the number of demodex might be the pathogen causing blepharitis with cylindrical dandruff, and cleaning of the eyelid margin is effective as a therapeutic method.



Nippon Ganka Gakkai Zasshi. 2010 Dec;114(12):1025-9.
[Article in Japanese]
Kawakita T, Kawashima M, Ibrahim O, Murato D, Tsubota K.
Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan. kawakita@sc.itc.keio.ac.jp

Abstract: Ocular rosacea - or maybe demodex after all?

Interesting.

Some of you without facial rosacea who have been diagnosed with ocular rosacea might want to discuss this "rosacea-like demodicidosis" concept with your doctor.

It's always heartening to see a study (even just a case study) saying things like "complete remission without recurrence".

[Rosacea-like demodicidosis and chronic blepharitis.]

Demodicidosis is a parasitic skin disease caused by the follicle mites Demodex sp. In this article, we present a case of rosacea-like demodicidosis, discuss the clinical features of Demodex infestation in man and review their diagnosis and therapeutic modalities. A 37-year-old woman presented in our department with chronic blepharitis present for one year. On physical examination, the patient presented blepharitis and papulovesicles with fine scaling limited to the face. There was no telangectasia. The patient did not report flushing episodes or any kind of photosensitivity. A diagnosis of rosacea-like demodicidosis and Demodex blepharitis was based on the presence of numerous Demodex folliculorum in the eyelashes and scrapings of skin lesions. The patient was put on topic and oral metronidazole for 2 months and on yellow mercury ointment for 15 days. The course involved disappearance of the facial mites and complete remission without recurrence. Screening for Demodex sp is essential to establish the correct diagnosis and ensure suitable treatment.


Ann Dermatol Venereol. 2011 Jan;138(1):30-34.
[Article in French]
Anane S, Mokni M, Beltaief O.
Laboratoire de parasitologie, faculté de médecine de Tunis, 15, rue Djebel Lakhdhar, 1007 Tunis, Tunisie.

Abstract: Other medical conditions common amongst people with blepharitis

Associated Morbidity of Blepharitis.

OBJECTIVE: To evaluate the prevalence of systemic medical conditions in patients with blepharitis.

DESIGN: A retrospective observational case-control study.

PARTICIPANTS AND CONTROLS: All the members who were diagnosed with blepharitis in the Central District of Clalit Health Services in Israel (years 2000-2009; n=16706) and 16706 age- and gender-matched controls randomly selected from the district members.

METHODS: Analysis of the prevalence of various ocular and systemic conditions, risk factors, age, gender, marriage status, country of origin, place of residency, and socioeconomic status.

MAIN OUTCOME MEASURES: The prevalence of any associated morbidity.

RESULTS: Demographically, a significantly higher tendency to develop blepharitis was found in populations of lower socioeconomic class, populations living in urban areas, and Ashkenazi Jews. A significant association of P<0.001 was found with some inflammatory diseases (gastritis, peptic ulcer, asthma, arthropathy, and ulcerative colitis), psychologic conditions (anxiety, irritable bowel syndrome, neuroses, and depression), hormonal conditions (hypothyroidism and prostatic hypertrophy), cardiovascular diseases (carotid artery disease, hyperlipidemia, hypertension, and ischemic heart disease), and other eye conditions (chalazion, pterygium). The strongest associations found were between blepharitis and chalazia (odds ratio [OR] 4.7; confidence interval [CI], 3.8-5.7), rosacea (OR 3; CI, 2.1-4.3), pterygia (OR 2.0; CI, 1.5-2.6), ulcerative colitis (OR 2.3; CI, 1.2-4.2), irritable bowel syndrome (OR 1.8; CI, 1.3-2.5), anxiety (OR 1.6; CI, 1.4-1.9), and gastritis (OR 1.6; CI, 1.4-1.7).

CONCLUSIONS: Some ocular and systemic conditions are more prevalent among patients with blepharitis. Better understanding of the pathophysiologic association between those diseases and blepharitis may help in its treatment and prevention.

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


Ophthalmology. 2011 Jan 26. [Epub ahead of print]
Nemet AY, Vinker S, Kaiserman I.
Department of Ophthalmology, Meir Medical Center, Kfar Sava, Israel.

OTC news: Puralube is back

For some few of you who have been missing it.... For those who aren't familiar with it, it's another night ointment like the various "PM" products on the market. Most of these PM products are made of petrolatum and mineral oil in varying proportions. This one is 85% petrolatum and 15% mineral oil, like Genteal PM I believe.

Fera Pharmaceuticals Launches OTC Puralube® Ophthalmic Ointment for Dry Eye

Puralube, a preservative free ophthalmic ointment, is one that has been relied upon by patients and healthcare professionals for years to relieve the symptoms of dry eye. When the original manufacturer of Puralube discontinued the product, Fera was inundated with requests to bring the product back.

Frank DellaFera, President of Fera states, “Puralube is a product that fits perfectly with our eye care portfolio. We are so pleased to make Puralube available again, giving patients, pharmacists and physicians a cost effective and reliable treatment option for dry eye symptoms”.

Fera is launching Puralube in a 3.5 g tube as well as a carton of 20 1 g tubes. It will be available through retail, wholesale and mail order pharmacy.