NCT04405245

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

Phase 2 Multi-Center, Double-Masked, Randomized, 28-Day Study to Assess the Efficacy, Safety and Tolerability of Single or Twice Daily Doses of AKB-9778 Ophthalmic Solution as an Adjunct to Latanoprost in Patients With Ocular Hypertension (OHT) or Open Angle Glaucoma (OAG)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: EyePoint Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ocular Hypertension
• Primary Open Angle Glaucoma

Interventions

Type	Name	Description
DRUG	Latanoprost ophthalmic solution	Latanoprost opthalmic solution to be dosed once daily
DRUG	AKB-9778 4%	Razuprotafib opthalmic solution
DRUG	Placebo	placebo for razuprotafib opthalmic solution

Timeline

• Start date: 2020-06-06
• Primary completion: 2020-11-05
• Completion: 2020-11-05
• First posted: 2020-05-28
• Last updated: 2023-05-25
• Results posted: 2023-05-25

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study