Safety and Efficacy of T-2345 Compared to Xalatan in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Summary
This is a Phase 3 study to evaluate the safety and efficacy of T-2345 dosed to one of both eyes once daily for 84 days compared to Xalatan dosed to one of both eyes once daily for 84 days in patients with elevated eye pressure.
Timeline
- Start
- 2014-01
- Primary completion
- 2015-01
- Completion
- 2015-01
Outcome
Met primary endpoint
registry analysis (equivalence test); T-2345 vs Xalatan; p = 0.0091; Mean Difference (Final Values) 0.781 (95% CI 0.195 to 1.366); ANCOVA NCT02059278 ↗
registry analysis (equivalence test); T-2345 vs Xalatan; p = 0.0098; Mean Difference (Final Values) 0.664 (95% CI 0.161 to 1.167); ANCOVA NCT02059278 ↗
registry analysis (equivalence test); T-2345 vs Xalatan; p = 0.0398; Mean Difference (Final Values) 0.542 (95% CI 0.025 to 1.058); ANCOVA NCT02059278 ↗
registry analysis (equivalence test); T-2345 vs Xalatan; p = 0.1008; Mean Difference (Final Values) 0.478 (95% CI -0.093 to 1.050); ANCOVA NCT02059278 ↗
registry analysis (equivalence test); T-2345 vs Xalatan; p = 0.0558; Mean Difference (Final Values) 0.505 (95% CI -0.013 to 1.024); ANCOVA NCT02059278 ↗
registry analysis (equivalence test); T-2345 vs Xalatan; p = 0.0491; Mean Difference (Final Values) 0.538 (95% CI 0.002 to 1.074); ANCOVA NCT02059278 ↗
registry analysis (equivalence test); T-2345 vs Xalatan; p = 0.0025; Mean Difference (Final Values) 0.808 (95% CI 0.286 to 1.329); ANCOVA NCT02059278 ↗
registry analysis (equivalence test); T-2345 vs Xalatan; p = 0.0113; Mean Difference (Final Values) 0.627 (95% CI 0.143 to 1.111); ANCOVA NCT02059278 ↗
registry analysis (equivalence test); T-2345 vs Xalatan; p = 0.0649; Mean Difference (Final Values) 0.456 (95% CI -0.063 to 0.975); ANCOVA NCT02059278 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Latanoprost | Small molecule | 0.005 % | Other |