drugset / Trial / NCT06394973

Efficacy and Safety Assessment of T4090 Ophthalmic Solution Versus Rhopressa® Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension

NCT06394973 ↗

Phase 2 Completed 161 enrolled Laboratoires Thea
RandomizedParallel-groupSingle-blindTreatment

Summary

The main purpose is to compare the ocular hypotensive efficacy and safety of two concentrations of T4090 (Kinezodianone R HCl 0.2% and 0.3%) ophthalmic solution with Rhopressa® ophthalmic solution

Timeline

Start
2024-08-05
Primary completion
2024-11-21
Completion
2024-11-21

Outcome

Missed primary endpoint

registry analysis (other test); T4090 0.2% vs Rhopressa®; p = 0.376; Mean Difference (Final Values) -0.49; Mixed Models Analysis NCT06394973 ↗

registry analysis (other test); T4090 0.3% vs Rhopressa®; p = 0.518; Mean Difference (Final Values) -0.36; Mixed Models Analysis NCT06394973 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Kinezodianone R Unknown 0.2 % Other
Subject Kinezodianone R Unknown 0.3 % Other
Comparator Netarsudil Small molecule 0.02 % Other