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

• Status: Completed
• Trial end date: 2020-11-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aerpio Therapeutics
• Treatments: Latanoprost; Ophthalmic Solutions

Criteria

Key Inclusion Criteria:

• Diagnosis of OAG or OHT in each eye (OAG in one eye and OHT in the fellow eye is acceptable)

• Must be receiving treatment with a stable regimen of topical prostaglandin eyedrop for a minimum of 2 weeks prior to the Screening Visit; may be taking one additional IOP lowering eyedrop

• IOP of ≥ 18 mmHg and ≤ 27 mmHg in one eye at Screening visit

• Following 4 week washout period, IOP ≥ 24 mmHg and < 36 mmHg at 08:00 hour and IOP ≥ 22 mmHg and < 36 mmHg in both eyes at 10:00, 12:00 and 16:00 hours.

Key Exclusion Criteria:

• Clinically significant ocular disease which might interfere with interpretation of the study efficacy endpoints or with safety assessments

• Pseudoexfoliation or pigment dispersion component glaucoma

• History of angle closure glaucoma, or narrow angles or with evidence of peripheral anterior synechiae (PAS) ≥ 180 degrees by gonioscopy within 6 months prior to Screening

• Intraocular pressure ≥ 36 mmHg

• Cup/disc ratio of > 0.8 in either eye

• Severe visual field defect or significant defect (sensitivity of ≤ 10dB) within 10 degrees of fixation in either eye