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

EyePoint Pharmaceuticals, Inc.194 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

194

Conditions

Ocular Hypertension Primary Open Angle Glaucoma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 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 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

Locations (21)

United Medical Research Institute

Inglewood, California, United States

North Valley Eye Medical Group

Mission Hills, California, United States

Eye Research Foundation

Newport Beach, California, United States

North Bay Eye Associates

Petaluma, California, United States

Shettle Eye Research

Largo, Florida, United States

Clayton Eye Clinical Research, LLC

Morrow, Georgia, United States

Coastal Research Associates

Roswell, Georgia, United States

Kannarr Eye Care

Pittsburg, Kansas, United States

Heart of America Eye Care, P.A.

Shawnee Mission, Kansas, United States

Tekwani Vision Center

St Louis, Missouri, United States

...and 11 more locations

Outcomes

Primary Outcomes

Change From Baseline in Intraocular Pressure at Day 28 (Study Eye)

Change from Baseline in Diurnal Mean IOP (mmHg) at Day 28 in the Study Eye -- ITT Population

Time frame: Baseline to Day 28

Secondary Outcomes

Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye)

Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 in the Study Eye -- ITT Population

Time frame: Baseline to Day 14

Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes)

Mean change from baseline in diurnal mean IOP (measured in mmHg) at Day 14 and 28 in both eyes - ITT Population

Time frame: Baseline to Day 14 and Baseline to Day 28

Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes)

Mean of the Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in both eyes -- ITT Population

Time frame: Baseline to Day 14 and Baseline to Day 28

Mean Observed IOP at Each Time Point on Days 14 and 28

Mean observed IOP measured in mmHg at each time point on Days 14 and 28 (study eye) - ITT Population

Time frame: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28

Mean Change From Baseline IOP at Each Time Point on Days 14 and 28

Change from Baseline in Mean IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population

Time frame: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28

Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28

Percent Change from Baseline IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population

Time frame: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28

Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28

Percent Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in the Study Eye -- ITT Population

Time frame: Baseline to Day 14 and Baseline to Day 28

Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels

Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels in Study Eye -- ITT Population

Time frame: Baseline to Day 28