Summary
BACKGROUND: Perfluorohexyloctane ophthalmic solution (PFHO) is indicated for the treatment of signs and symptoms of dry eye disease (DED). In randomized controlled trials, significant reductions in signs and symptoms of DED were observed beginning at day 15 (the first postbaseline assessment) for PFHO compared with a hypotonic saline control. This prospective, multicenter, open-label, phase 4 study evaluated patient perceptions and satisfaction during the first 14 days of treatment with PFHO.
METHOD: This study enrolled adults with a history of DED for =6 months and clinical signs of Meibomian gland dysfunction. PFHO was instilled in both eyes QID for 14 days. Patients completed early outcome surveys during 4 clinic visits: day 1 (pretreatment [baseline]; 5 and 60 minutes post-PFHO instillation) and days 3, 7, and 14. DED symptom severity (overall and each of 8 individual symptoms) and treatment satisfaction were rated on a visual analog scale (range, 0-100). The Ocular Surface Disease Index (OSDI) was completed at baseline and day 14.
RESULTS: Ninety-nine patients were enrolled (mean age, 61.3 years; 85.9% females). Mean (SD) VAS score for overall DED symptom severity was 72.1 (17.0) at baseline and decreased to 38.5 (22.8) at 5 minutes post-instillation, 31.7 (22.1) at 60 minutes post-instillation, 33.2 (25.1) at day 3, 27.8 (22.3) at day 7 (primary endpoint), and 24.7 (23.0) at day 14. Reduction in overall symptom severity was statistically significant at all postbaseline timepoints, including the day 7 primary endpoint (mean change from baseline: -44.5 [61.7% reduction]; P<0.0001). significant reductions in severity were also observed for all 8 symptoms eye dryness burning stinging eye itching light sensitivity eye pain eye tiredness eye irritation and blurred vision at all postbaseline assessments p><0.0001). mean sd osdi total score decreased from 50.5 16.7 at baseline to 18.4 13.9 at day 14 mean change from baseline: -32.1 p><0.0001). median ratings of treatment satisfaction were 83.0 at day 3 86.0 at day 7 and 90.0 at day 14.>0.0001).>0.0001).>0.0001).>
CONCLUSION: Early in the course of treatment with PFHO, patients with DED experienced significant reductions in dry eye symptom severity. Treatment satisfaction with PFHO was high.