ARVO 2009: Hydroxypropyl Cellulose Ophthalmic Inserts Improve Symptoms, QoL in Dry Eye Syndrome

Deborah Brauser

May 11, 2009

May 11, 2009 (Fort Lauderdale, Florida) — Hydroxypropyl cellulose ophthalmic inserts significantly reduce symptoms and clinical signs of moderate to severe dry-eye syndrome (DES) and improve patient quality-of-life (QoL) scores, according to results from a multicenter open-label study presented here at the Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting.

"Almost 5 million Americans over the age of 50 have DES, which can have a significant impact on daily living," reported lead investigator Bruce H. Koffler, MD, from Koffler Vision Group in Lexington, Kentucky, during a poster presentation. However, he said that there is a lack of correlation between patients' symptoms and the results of clinical trials.

In this 4-week study, Dr. Koffler and colleagues sought to determine the acceptability and ease of use of once-daily hydroxypropyl cellulose ophthalmic inserts for the treatment of DES symptoms.

"This product has been around for a long while," explained Dr. Koffler. "I was using it in the late 70s or early 80s with some significant success. But it experienced some production problems, which made it difficult for patients to get, and I think a lot of doctors got frustrated and stopped prescribing it or forgot about it." The inserts are now made by a new company.

For this study, 520 adult patients with a history of moderate to severe DES in both eyes were enrolled in 1 of 49 study sites across the United States. A total of 418 patients (80.4%) completed the study, 64.8% of whom were female and 54.6% of whom were 50 years or older.

At their first visit, all patients received a general dry-eye evaluation, screened by slit-lamp biomicroscopy and best corrected visual acuity, and filled out a questionnaire to complete the ocular surface disease index (OSDI) for QoL measurement. In addition, each patient was trained at that time on the proper insertion and use of the study drug. On their second visit, on day 28 (±3 days), the patients received another clinical evaluation and completed a second questionnaire to determine changes in their symptoms and QoL.

Results at the 4-week mark showed significant improvements in the DES symptoms of discomfort (24.9% reduction), burning (34.9% reduction), dryness (41.9% reduction), grittiness (29.0% reduction), stinging (28.5% reduction), and sensitivity to light (18.9% reduction) (= .05). Significant improvements were also reported in clinical signs, such as keratitis, conjunctival staining, and tear volume.

In addition, mean OSDI total scores significantly improved by 21.3% (from 41.8 ± 22.38 to 32.9 ± 21.97; P ≤ .0215). This finding surprised Dr. Koffler. "I was looking for more like a 5% or 10% change," he said. "When you get a 20% to 25% change in OSDI, that's a big deal and a big change in patient symptomology."

There were no serious adverse events reported; blurred vision was the most commonly reported adverse event, observed in 8.7% of the patients (n = 45) and leading to discontinuation.

"This is likely due to the thickened precorneal tear film observed after the placement of the inserts," said Dr. Koffler. "This illustrates the importance of instructing patients on the best way to apply the treatment. Maybe instead of using it in the morning, they should put it in at night so it has time to half-way dissolve throughout the nighttime hours, while also giving a lot of nighttime relief."

Finally, 41.5% of the subjects were fully compliant, with the majority (69.4%) of the others missing 1 to 5 doses.

"After only 1 month of treatment, patients had significant reductions in the severity and number of their DES symptoms, along with less difficulty when performing daily tasks, such as reading, ability to drive at night, and ability to watch TV," said Dr. Koffler.

When asked why the study was only 4 weeks in duration, he said: "We wanted to see if we could get statistically significant results in a short period of time, which we did."

Michael A. Lemp, MD, clinical professor of ophthalmology at Georgetown and George Washington University of Medicine in Washington, DC, told Medscape Ophthalmology that "it's an interesting study, but it's not surprising to me. The insert, which has been around for a long time, tended to reduce symptoms in patients. And when you do that, you almost always improve quality of life." Dr. Lemp was not associated with this trial.

"One thing that does stand out in the study, and I understand why they did it, is that this is a group of patients who had a high degree of symptoms," continued Dr. Lemp. "These patients had [an initial] mean score of almost 42 on OSDI, which is a pretty high disease index score for symptoms. But if you didn't have a score this high to start with, you couldn't pick up changes like this. If you started off with a score of 10 or 12, it probably wouldn't have a statistically significant difference. So it was probably appropriate to target this treatment group for this study."

Overall, Dr. Lemp concluded, "I think this is a good study. It shows the utility that the insert has, particularly in patients who have moderate to severe symptoms of [DES]. And I am delighted that this is widely available again, because it's been essentially unavailable except for compassionate use. It gives another option."

This study was funded by Aton Pharma. Dr. Koffler is on the speaker's bureau and advisory board for Aton. Dr. Lemp has consulted for Aton in the past, but not in relation to this study or treatment.

Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting: Abstract 4660. Presented May 6, 2009.


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