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
- Conditions
- Primary Open Angle GlaucomaOcular Hypertension
- Interventions
- Registration Number
- NCT04405245
- Lead Sponsor
- EyePoint Pharmaceuticals, Inc.
- 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% 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 194
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AKB-9778 4% BID + Latanoprost Latanoprost ophthalmic solution • AKB-9778 4% twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days AKB-9778 4% BID + Latanoprost AKB-9778 4% • AKB-9778 4% twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days AKB-9778 4% QD + Latanoprost Latanoprost ophthalmic solution • AKB-9778 4% daily (AM) and placebo for ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days AKB-9778 4% QD + Latanoprost AKB-9778 4% • AKB-9778 4% daily (AM) and placebo for ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days Placebo Twice Daily + Latanoprost Latanoprost ophthalmic solution • Placebo for AKB-9778 4% ophthalmic solution twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days Placebo Twice Daily + Latanoprost Placebo • Placebo for AKB-9778 4% ophthalmic solution twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days
- Primary Outcome Measures
Name Time Method Change From Baseline in Intraocular Pressure at Day 28 (Study Eye) Baseline to Day 28 Change from Baseline in Diurnal Mean IOP (mmHg) at Day 28 in the Study Eye -- ITT Population
- Secondary Outcome Measures
Name Time Method Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes) Baseline to Day 14 and Baseline to Day 28 Mean of the Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in both eyes -- ITT Population
Mean Observed IOP at Each Time Point on Days 14 and 28 Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28 Mean observed IOP measured in mmHg at each time point on Days 14 and 28 (study eye) - ITT Population
Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28 Baseline to Day 14 and Baseline to Day 28 Percent Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 and Day 28 in the Study Eye -- ITT Population
Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes) Baseline to Day 14 and Baseline to Day 28 Mean change from baseline in diurnal mean IOP (measured in mmHg) at Day 14 and 28 in both eyes - ITT Population
Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye) Baseline to Day 14 Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 in the Study Eye -- ITT Population
Mean Change From Baseline IOP at Each Time Point on Days 14 and 28 Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28 Change from Baseline in Mean IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population
Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28 Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28 Percent Change from Baseline IOP (mmHg) at Each Time Point on Day 14 and Day 28 in the Study Eyes -- ITT Population
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels Baseline to Day 28 Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels in Study Eye -- ITT Population
Trial Locations
- Locations (20)
Kannarr Eye Care
🇺🇸Pittsburg, Kansas, United States
Heart of America Eye Care, P.A.
🇺🇸Shawnee Mission, Kansas, United States
Shettle Eye Research
🇺🇸Largo, Florida, United States
Tekwani Vision Center
🇺🇸Saint Louis, Missouri, United States
United Medical Research Institute
🇺🇸Inglewood, California, United States
Eye Research Foundation
🇺🇸Newport Beach, California, United States
Coastal Research Associates
🇺🇸Roswell, Georgia, United States
Apex Eye
🇺🇸Cincinnati, Ohio, United States
North Valley Eye Medical Group
🇺🇸Rochester, New York, United States
North Bay Eye Associates
🇺🇸Petaluma, California, United States
Charlotte Eye, Ear, Nose & Throat Assoc. (CEENTA)
🇺🇸Charlotte, North Carolina, United States
James D. Branch, MD Ophthalmology
🇺🇸Winston-Salem, North Carolina, United States
Abrams Eye Center
🇺🇸Cleveland, Ohio, United States
Mark J. Weiss, MD, Inc.
🇺🇸Tulsa, Oklahoma, United States
Scott & Christie and Assoc
🇺🇸Cranberry Township, Pennsylvania, United States
Total Eye Care
🇺🇸Memphis, Tennessee, United States
Texan Eye / Keystone Research
🇺🇸Austin, Texas, United States
Clayton Eye Clinical Research, LLC
🇺🇸Morrow, Georgia, United States
Advancing Vision Research
🇺🇸Nashville, Tennessee, United States
Eye Care Specialists
🇺🇸Kingston, Pennsylvania, United States