Safety and Efficacy Assessment of Monoprost® in Comparison With Lumigan® 0.01 % and Lumigan® 0.03% Unit Dose

Summary

Primary objective: The primary objective is to demonstrate the superiority of Monoprost® versus Lumigan® 0.01% and Lumigan® 0.03% Unit Dose in term of safety with respect to the assessment of conjunctival hyperaemia in the worse eye at Day 84. The conjunctival hyperaemia will be scored using the MacMonnies photographic scale (0 to 5).

Timeline

Start

2013-12

Primary completion

2016-07

Completion

2016-07

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

registry analysis (superiority test); Monoprost vs Lumigan 0.03% Unit Dose; p <0.0001; Cochran-Mantel-Haenszel NCT02017327 ↗

Drugs

Indications