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

Ocular Hypertension Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04405245
• Other study ID #: AKB-9778-CI-OS-2001
• Status: Completed
• Phase: Phase 2
• Start date: June 6, 2020
• Est. completion date: November 5, 2020

Study information

• Verified date: May 2023
• Source: EyePoint Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: November 5, 2020
• Est. primary completion date: November 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open Angle Glaucoma

Intervention

Drug:
• Latanoprost ophthalmic solution
Latanoprost opthalmic solution to be dosed once daily
• AKB-9778 4%
Razuprotafib opthalmic solution
• Placebo
placebo for razuprotafib opthalmic solution

Locations

Country	Name	City	State
United States	Texan Eye / Keystone Research	Austin	Texas
United States	Charlotte Eye, Ear, Nose & Throat Assoc. (CEENTA)	Charlotte	North Carolina
United States	Apex Eye	Cincinnati	Ohio
United States	Abrams Eye Center	Cleveland	Ohio
United States	Scott & Christie and Assoc	Cranberry Township	Pennsylvania
United States	United Medical Research Institute	Inglewood	California
United States	Eye Care Specialists	Kingston	Pennsylvania
United States	Shettle Eye Research	Largo	Florida
United States	Total Eye Care	Memphis	Tennessee
United States	North Valley Eye Medical Group	Mission Hills	California
United States	Clayton Eye Clinical Research, LLC	Morrow	Georgia
United States	Advancing Vision Research	Nashville	Tennessee
United States	Eye Research Foundation	Newport Beach	California
United States	North Bay Eye Associates	Petaluma	California
United States	Kannarr Eye Care	Pittsburg	Kansas
United States	North Valley Eye Medical Group	Rochester	New York
United States	Coastal Research Associates	Roswell	Georgia
United States	Tekwani Vision Center	Saint Louis	Missouri
United States	Heart of America Eye Care, P.A.	Shawnee Mission	Kansas
United States	Mark J. Weiss, MD, Inc.	Tulsa	Oklahoma
United States	James D. Branch, MD Ophthalmology	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
EyePoint Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline to Day 28
Secondary	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	Baseline to Day 14
Secondary	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	Baseline to Day 14 and Baseline to Day 28
Secondary	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	Baseline to Day 14 and Baseline to Day 28
Secondary	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	Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28
Secondary	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	Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28
Secondary	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	Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28
Secondary	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	Baseline to Day 14 and Baseline to Day 28
Secondary	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	Baseline to Day 28