Slow-Release Ophthalmic Inserts Improve Signs and Symptoms of Dry Eye

Fran Lowry

May 11, 2010

May 11, 2010 (Fort Lauderdale, Florida) — One month of treatment with hydroxypropyl cellulose ophthalmic inserts (HCOI) improved the signs and symptoms of dry eye syndrome, according to a registry study of 418 patients presented in a poster here at the Association for Research in Vision and Ophthalmology 2010 Annual Meeting.

The inserts, called Lacriserts (Aton Pharma, Inc), were originally marketed in the 1970s by Merck, Jodi Luchs, MD, from Albert Einstein College of Medicine and South Shore Eye Care in Wantagh, New York, told Medscape Ophthalmology. "Many clinicians aren't aware that the product is back on the market. We're trying to get the word out that this is a good way of treating patients who are in the moderate-to-severe category who really don't have a lot of good options currently available to them."

The patients filled out a questionnaire that asked them about their symptoms and degree of ocular discomfort in various environmental conditions at baseline and 1 month after treatment. Of these patients, 65% were designated as being moderate or severe, according to the Ocular Surface Disease Index (OSDI) and activities of daily living scale. Tear film break-up time (TFBUT) was also measured.

The hydroxypropyl cellulose ophthalmic inserts were inserted once daily.

After 1 month of treatment, there were significant differences in OSDI scores between severe and moderate groups, Dr. Luchs reported. The largest decrease in scores was seen in the severe group (29.8%; P < .001). Scores in the moderate group decreased by 18.9% (P = .016).

Improvement in OSDI scores for patients in the study was over and above any improvement patients gained from dry eye therapies that they received before the study, Dr. Luchs said.

The study also found that there were significant increases in OSDI scores of 83.7% (P =.001) and 30.2% (P =.01) for the normal and mild groups, respectively. There was also a significant shift in the severity category. At the beginning of the study, 65% of patients had severe dry eye syndrome. After 1 month, 44% of those patients scored within the severe range, shifting the distribution to normal, mild, and moderate groups.

Dr. Luchs also reported that there was a significant increase in TFBUT for the left eye in the normal group (P <.05), compared with baseline, but there were no increases in either eye for mild or moderate groups. In the severe group of patients, there was a significant increase in TFBUT for both eyes (P < .005), compared with baseline.

The most commonly reported adverse effect was blurred vision, Dr. Luchs said.

"[HCOI] is a rod of material made up of hydroxypropyl cellulose that is placed into the interior eyelid sac where it remains throughout the day, slowly dissolving and releasing the material, so it is considered sustained-release artificial tears," he explained. "You put it in, similar to a contact lens, you feel it for about a minute, and then it sits there and slowly dissolves. It has been approved by the [US Food and Drug Administration] for years."

He added that "this study did not exclude patients who were on [cyclosporine] and, in fact, we think that patients who are on [cyclosporine] and who have moderate-to-severe dry eye do better with [HCOI] added to their regimen."

Asked to comment on this study for Medscape Ophthalmology, Elizabeth Yeu, MD, from the Cullen Eye Institute, Baylor College of Medicine, in Houston, Texas, said the findings support her experience with HCOI in her dry eye patients.

"The findings of this poster are very relevant, clinically. Because there sometimes is a disconnect between patients' symptoms and clinicians' exam findings, the OSDI is a wonderful tool to help clinicians translate the severity of patients' dry eye disease," said Dr. Yeu, who was not part of the study.

"As demonstrated, the patients who benefit the most from HCOI are those who have more moderate-to-severe disease processes, where there is a frequent demand for lubrication to alleviate their symptoms," she added. "Patients who need artificial lubrication more than 4 to 6 times daily experience a great improvement in their quality of life from having the consistent moisture provided by the insert."

The study was supported by Aton Pharma, Inc. Dr. Luchs and Dr. Yeu report financial relationships with Aton Pharma Inc.

Association for Research in Vision and Ophthalmology (ARVO) 2010 Annual Meeting: Abstract 6262. Presented May 6, 2010.

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