By Fred Gebhart
SAN FRANCISCO -- October 29, 2009 -- Active treatment topical cyclosporine 0.05% is an appropriate option for many patients with dry eye, according to second-year trial data presented as a poster at the 2009 Joint Meeting of the American Association of Ophthalmology and Pan-American Association of Ophthalmology (AAO-PAAO).
Data came from a 1-year crossover extension of a trial that compared topical cyclosporine with traditional palliative treatment for dry eye, said Sanjay Rao, MD, Lakeside Eye Clinic, Chicago, Illinois. An international task force recommended in 2006 that patients with level 2 severity use topical anti-inflammatory treatment, but patients with dry eye are typically advised to use palliative products such as artificial tears.
In the original trial, 36 patients with level 2 or level 3 dry eye used an ophthalmic cyclosporine 0.05% emulsion twice daily and 22 patients with similar disease severity used artificial tears for 12 months. In a second-year crossover trial, patients who had started on artificial tears switched to cyclosporine and cyclosporine patients were randomised 2:1 to continue cyclosporine or switch to artificial tears.
At the end of the first year, topical cyclosporine slowed or prevented the progression of dry eye compared with artificial tears. Dr. Rao reported similar results here on October 26 from the crossover trial.
Among patients who were already taking cyclosporine and continued the drug, 85% showed no progression in disease and 15% showed improvement. Patients who switched from artificial tears to cyclosporine showed similar results -- 85% with no progression and 15% with improvement. None of the patients who received cyclosporine during this second year reported disease progression. Among patients who switched from cyclosporine to artificial tears, however, 50% showed progression of disease and 50% showed no progression. None of the patients on artificial tears during the second year reported any improvement in symptoms.
Schirmer test scores showed a similar pattern. The mean percentage change in Schirmer score among patients who continued on cyclosporine (+10.4%) and patients who switched from artificial tears to cyclosporine (+24.0%) was significantly better than among patients who switched from cyclosporine to artificial tears (-15.7%) (P < .001).
Results were the same for tear breakup time as measured by fluorescein dye, goblet-cell density determined by impression cytology, ocular-surface staining as evaluated by the Oxford method, and symptoms of ocular irritation as assessed by the Ocular Surface Disease Index (OSDI). In all 4 measures, the cyclosporine-to-artificial tears arm scored significantly more poorly than the cyclosporine-only arm or the artificial-tears-to-cyclosporine arm (P < .001 for all 4 measures).
The only reported adverse event attributable to the study agents was discomfort upon instillation.
Dr. Rao noted that these results suggest that topical cyclosporine 0.05% is both safe for long-term use and effective in controlling progression of dry-eye disease. Earlier use of cyclosporine may result in improved outcomes.
[Presentation title: Topical Cyclosporine 0.05% for Prevention of Dry Eye Disease: Year Two. Abstract PO386]
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