Wednesday, March 9, 2011

Product recall: Soothe XP

First Soothe Xtra Hydration, now Soothe XP - it's a bad quarter for B&L's OTC line.

Voluntary Recall of Soothe® Xtra Protection (XP) Eye Drops

MADISON, N.J.—Bausch + Lomb, the global eye health company, is conducting a voluntary recall of its Soothe® Xtra Protection (XP) eye drops....

Bausch + Lomb chose to initiate this recall based on testing which showed specific lots of the Soothe Xtra Protection (XP) product were out of specification for preservative efficacy prior to their listed date of shelf-life expiration. There have been no adverse events reported for this product which have been attributed to preservative efficacy.

Bausch + Lomb has chosen to voluntarily recall ALL LOTS of Soothe Xtra Protection (XP) eye drops in the interest of patient safety. Product which is out of specification near the end of shelf-life may present insufficient protection against inadvertent microbial contamination during storage and usage of the product. Potential adverse events may include: burning, stinging, eye redness or eye discomfort. Please contact your doctor if you have any of these symptoms.

Contact info:

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

Soothe Xtra Protection (XP) Hotline: 1-866-761-9526

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.

Tuesday, March 8, 2011

CLS Article: Therapeutic lens use in corneal dystrophies

This very thorough article in Contact Lens Spectrum caught my eye....

Managing Corneal Dystrophies With Lenses
New designs and materials can aid practitioners in treating dystrophies and associated conditions.
Long D. Tran, OD, FAAO (CLS March 2011)

The array of symptoms that patients who have corneal dystrophic disease will experience can vary from none to severe. In the early stages of the disease, patients may complain only of blurry vision and/or a foreign body sensation. In the advanced stages of the disease, patients may have limited vision in conjunction with severe discomfort or pain.

Treating these corneal dystrophies, by and large, involves managing patients' symptoms during episodes of epithelial and stromal compromise. Poor epithelial adhesion due to a physiologic change of any of the underlying corneal layers (basement membrane, Bowman's layer, stroma, and endothelium) may result in epithelial defects and erosions. Patients who suffer from corneal erosions require prompt management of the pain and decreased vision. While therapeutic and surgical options are both viable, bandage soft contact lenses can serve as a useful and readily available alternative. In addition to reducing patient symptoms and promoting corneal healing, bandage contact lenses may also delay the need for more invasive treatment procedures such as corneal stromal puncture or phototherapeutic keratectomy.

Of particular interest to me was the table at the end of the article. I had no idea there were so many different dystrophies that could present with recurrent erosions. Other than ABMD and Fuch's many of these were new to me:

Abstract: Meibum collection techniques

Examination of Human Meibum Collection and Extraction Techniques.

To compare various meibum collection methods and extraction techniques.

Sixty subjects, all successful contact lens wearers, were seen on two visits. Meibum was collected from the lower lid of the right eye with a glass microcapillary tube, and with a Dacron swab, cytology microbrush, or spatula from the left eye. Extraction with 2:1 chloroform:methanol was done either immediately or after data collection was complete. Individual samples were divided into four equal aliquots for analysis of total lipids, cholesterol, and inorganic phosphates by assay-based techniques. Effects of collection method, extraction, and dry eye status were examined using repeated measures analysis of variance and logistic regression.

Total lipids showed significance for collection device (p < 0.0001) but not for extraction technique (p = 0.13) or dry eye status (p = 0.97). Dacron swab collection was associated with more total lipid on average than each other collection device (p < 0.0001). The cholesterol assay showed significance of collection device (p < 0.0001) and extraction technique (p = 0.0002) but not dry eye status (p = 0.55). Spatula collection was associated with more cholesterol on average than each other collection device (p < 0.0001). For inorganic phosphates, immediate extraction (p < 0.0001), cytology microbrush collection (p < 0.0001), and non-dry eye status (p = 0.03) were associated with the greater likelihood of detection.

Dacron swab collection was associated with the highest average amount of total lipid detected, whereas spatula collection and immediate extraction was associated with the highest average amount of cholesterol detected. Cytology microbrush collection with immediate extraction on non-dry eye subjects was associated with the highest probability of detection of inorganic phosphates.

Optom Vis Sci. 2011 Mar 3. [Epub ahead of print]
Haworth KM, Nichols JJ, Thangavelu M, Sinnott LT, Nichols KK.
*OD, MS †OD, MPH, PhD, FAAO ‡MS §PhD The Ohio State University, College of Optometry, Columbus, Ohio.

Monday, March 7, 2011

Abstract: Ocular rosacea in northern Greece

Funny to see a dry eye study coming from my alma mater (Aristotle U in Thessaloniki)! This one is simple but good.

There has been very little study of the rosacea-dry eye connection. I had a quick scan through the literature and saw little that was recent. Most of what there is was published in Europe. I hope we see more studies soon. In clinic, more and more dry eye in the US is being blamed on rosacea of one sort or another.

Clinical and laboratory study of ocular rosacea in northern Greece.

The prevalence of ophthalmic involvement in rosacea is probably higher than previously presumed and varies considerably among several studies.

This study aimed to determine the incidence of ocular disease among a population of rosacea patients in Northern Greece, to objectively determine the presence of eye dryness in rosacea patients with and without clinical ophthalmic involvement and correlate the severity of ocular disease with the severity of cutaneous rosacea.

One hundred patients with rosacea were assessed for the stage of their disease and examined for ocular symptoms and signs. In 24 of them the tear break up time (TBUT) and Schirmer test were performed in each eye, along with 24 controls.

A total of 33 patients (33%) were positive for ophthalmic findings. The most frequent symptoms and signs were burning sensation and tearing, and conjunctivitis and blepharitis, respectively. Eleven patients with ophthalmic manifestations had mild to moderate erythematotelangiectatic rosacea, 17 had moderate papulopustular rosacea and four exhibited findings of phymatous rosacea. The total mean value of patients' Schirmer tests was significantly lower compared with the healthy controls (P < 0.0001). Mean TBUT was shorter in the rosacea group than that in the age-matched controls (P < 0.0001).

Ocular involvement in rosacea is a common phenomenon with eye dryness being an early sign. Tear function tests, like Schirmer test and TBUT, although not specific, could contribute to the screening and early diagnosis of the disease, to prevent the potential development of sight-threatening conditions.

J Eur Acad Dermatol Venereol. 2011 Mar 2. doi: 10.1111/j.1468-3083.2011.03995.x. [Epub ahead of print]
Lazaridou E, Fotiadou C, Ziakas N, Giannopoulou C, Apalla Z, Ioannides D.
First Departments of Dermatology-Venereology Ophthalmology, Aristotle University Medical School, Thessaloniki, Greece.

Abstract: Genes of the MGD patient

Changes In Gene Expression In Human Meibomian Gland Dysfunction.

Meibomian gland dysfunction (MGD) may be the leading cause of dry eye syndrome throughout the world. However, the precise mechanism(s) underlying the pathogenesis of this disease is unclear. We sought to identify meibomian gland genes that may promote the development and/or progression of human MGD.

Lid tissues were obtained from male and female MGD patients and age-matched controls after eyelid surgeries (e.g. to correct entropion or ectropion). Meibomian glands were isolated and processed for RNA extraction and the analysis of gene expression using BeadChips.

Our results show that MGD is associated with significant alterations in the expression of almost 400 genes in the human meibomian gland. The levels of 197 transcripts, including those encoding various small proline-rich proteins and S100 calcium binding proteins, are significantly increased, while the expression of 194 genes, such as for claudin 3 and cell adhesion molecule 1, is significantly decreased. These changes, which cannot be accounted for by sex differences, are accompanied by alterations in many gene ontologies (e.g. keratinization, cell cycle and DNA repair). Our findings also show that the human meibomian gland contains a number of highly expressed genes that are distinct from those in an adjacent tissue (i.e. conjunctival epithelium).

Our results demonstrate that MGD is accompanied by multiple changes in gene expression in the meibomian gland. The nature of these alterations, including the upregulation of genes encoding small proline-rich proteins and S100 calcium binding proteins, suggest that keratinization plays an important role in the pathogenesis of MGD.

Invest Ophthalmol Vis Sci. 2011 Mar 2. [Epub ahead of print]
Liu S, Richards SM, Lo K, Hatton M, Fay AM, Sullivan DA.
Schepens Eye Research Institute.