Status:
COMPLETED
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
Lead Sponsor:
EyePoint Pharmaceuticals, Inc.
Conditions:
Ocular Hypertension
Primary Open Angle Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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% adminis...
Eligibility Criteria
Inclusion
- Key
- 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 or both eyes 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
- 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
Key Trial Info
Start Date :
June 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2020
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT04405245
Start Date
June 6 2020
End Date
November 5 2020
Last Update
May 25 2023
Active Locations (21)
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1
United Medical Research Institute
Inglewood, California, United States, 90301
2
North Valley Eye Medical Group
Mission Hills, California, United States, 91345
3
Eye Research Foundation
Newport Beach, California, United States, 92663
4
North Bay Eye Associates
Petaluma, California, United States, 94954