Tolerability and effectiveness of preservative-free dorzolamide–timolol (preservative-free Cosopt®) in patients with open-angle glaucoma or ocular hypertension

Abstract

Cindy Hutnik1, David Neima2, Fahim Ibrahim3, Robert Scott4, Julie Vaillancourt5, Denis Haine5, John S Sampalis5, Natacha Bastien6, Sylvain Foucart61Ivey Eye Institute, St Joseph Healthcare, London, Ontario, Canada; 2New Westminster, British Columbia, Canada; 3Point Edward, Ontario, Canada; 4Kentville, Nova Scotia, Canada; 5JSS Medical Research, Westmount, Quebec, Canada; 6Merck Frosst Canada Ltd, Kirkland, Quebec, CanadaPurpose: To assess the effect of preservative-free dorzolamide–timolol on nonvisual symptoms and intraocular pressure (IOP) in newly diagnosed and untreated patients with open-angle glaucoma or ocular hypertension.Methods: This was a prospective, 8-week, open-label, Canadian multicenter study. All patients were treated with preservative-free dorzolamide–timolol formulation. The primary outcome was the change in the nonvisual symptom score of the Glaucoma Symptom Scale (GSS-SYMP-6) from baseline to 8 weeks. Secondary effectiveness outcome measures were absolute and percent changes in IOP from baseline to 4 and 8 weeks.Results: One hundred and seventy-eight patients were enrolled. Mean (SD) age was 65.6 (12.1) years and 90 (50.6%) were females. There were 92 patients diagnosed with open-angle glaucoma, 62 with ocular hypertension, and 23 with both diseases (diagnosis was missing for one patient). The mean (SD) GSS-SYMP-6 score increased from 73.6 (21.8) at baseline to 76.1 (20.7) at 8 weeks (P = 0.097). Mean (SD) IOP significantly decreased by 11.7 (5.1) mmHg at 4 weeks (P < 0.001) and by 11.5 (5.3) mmHg at 8 weeks (P < 0.001), representing reductions of -38.5% (P < 0.001) and -38.0% (P < 0.001), respectively.Conclusion: Preservative-free dorzolamide–timolol does not increase eye discomfort while significantly reducing IOP in patients with open-angle glaucoma or ocular-hypertension. Keywords: open-angle glaucoma, ocular hypertension, GSS-SYMP-6, intraocular pressure, dorzolamide–timolol, preservative-free