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

Abstract

Purpose: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.

Dorzolamide/Timolol Fixed Combination: Learning from the Past and Looking Toward the Future

“…There is little evidence [ 33 – 35 ] concerning the role of FCs as initial therapy in glaucoma. In general medical practice, initial therapy with FCs has been found to provide an improved clinical outcome in the management of several chronic diseases [ 36 , 37 ].…”

“…In general medical practice, initial therapy with FCs has been found to provide an improved clinical outcome in the management of several chronic diseases [ 36 , 37 ]. The most ample evidence in ophthalmology is with DTFC as initial therapy to promptly lower unacceptably high IOP in the presence of significant damage and particularly so in glaucomas with alarming 24-h IOP characteristics [ 33 – 35 ]. However, concerns exist if FCs are employed without a clear understanding of the clinical profile and safety of the components [ 24 ].…”

Improvement in Glaucoma Patient Quality of Life by Therapy Switch to Preservative-Free Timolol/Dorzolamide Fixed Combination

“…1 Mean change from baseline (in percent) of GSS total scores and both symptomatic (GSS-SYMP) and functional (GSS-FUNC) subcategories at the end of the study (week 8). The superscript letter a indicates a statistically significant difference compared to baseline; the superscript letter b indicates a clinically significant difference compared to baseline (difference in GSS score greater than 7, which is the amount of change used as surrogate for clinically significant improvement) [23]. Data presented as means and 95% confidence interval. …”

“…Our real-life assessment of the patient's own perception led to the choice of the validated and simple-to-use GSS questionnaire. This questionnaire stems from an adaptation to the Ocular Hypertension Treatment Study protocol questions and has been widely used in glaucoma studies focusing on the QoL [3,23,24]. In addition, it has been shown to possess a good correlation with ocular surface disease-related symptoms and suggested as an ideal instrument to be used without the need for an external observer [12], thus circumventing the limitations of an observational study setting.…”

Carbonic Anhydrase Inhibitors in the Treatment of Glaucoma. Review. Part II

“…Указанный эффект можно объяснить отсутствием консерванта Бензалкония Хлорида (БХ) и его токсического действия на ткани переднего отрезка глаза. Так, например, согласно данным экспериментального исследования, выполненного Kwon и соавт., повреждение эндотелия роговицы вызвано именно БХ, а не составляющими компонентами ФК Д/Т [21]. Применение ФК Д/Т, не содержащей консервантов, заметно повышает качество жизни больных глаукомой [22].…”