drugset / Trial / NCT02017327

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

NCT02017327

Phase 4 Completed 379 enrolled Laboratoires Thea
RandomizedParallel-groupSingle-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bimatoprost Other / unclassified 0.01 % Topical
Comparator Bimatoprost Other / unclassified 0.03 % Topical
Subject Latanoprost Small molecule 0.005 % Topical