Study to Assess the Efficacy, Safety and Tolerability of AKB-9778 Ophthalmic Solution as and Adjunct to Latanoprost in Patients With Ocular Hypertension or Open Angle Glaucoma
Summary
This is a phase 2, double masked, randomized, multi-center, parallel-group, 28-day study assessing the safety, tolerability and ocular hypotensive efficacy of AKB-9778 Ophthalmic Solution 4.0% administered once (AM) or twice (AM \& PM) daily when used as an adjunctive therapy to latanoprost ophthalmic solution 0.005% once daily (PM) in subjects with elevated IOP due to OAG or OHT.
Timeline
- Start
- 2020-06-06
- Primary completion
- 2020-11-05
- Completion
- 2020-11-05
Outcome
Mixed primary results
registry analysis (superiority test); AKB-9778 4% QD + Latanoprost; p = 0.8070; Mean Difference (Final Values) 0.09 (95% CI -0.63 to 0.81); ANCOVA NCT04405245 ↗
registry analysis (superiority test); AKB-9778 4% BID + Latanoprost; p = 0.0130; Mean Difference (Final Values) -0.92 (95% CI -1.64 to -0.20); ANCOVA NCT04405245 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AKB-9778 | Unknown | 4 % | Other |
| Background | Latanoprost | Small molecule | 0.005 % | Other |