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

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)

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 Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Intervention / Treatment: Drug: Latanoprost ophthalmic solution; Drug: AKB-9778 4%; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Inglewood, California, United States, 90301
      • United Medical Research Institute
    • Mission Hills, California, United States, 91345
      • North Valley Eye Medical Group
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates
  • Florida
    • Largo, Florida, United States, 33773
      • Shettle Eye Research
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Clinical Research, LLC
    • Roswell, Georgia, United States, 30076
      • Coastal Research Associates
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care
    • Shawnee Mission, Kansas, United States, 66204
      • Heart of America Eye Care, P.A.
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • Tekwani Vision Center
  • New York
    • Rochester, New York, United States, 14618
      • North Valley Eye Medical Group
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Charlotte Eye, Ear, Nose & Throat Assoc. (CEENTA)
    • Winston-Salem, North Carolina, United States, 27101
      • James D. Branch, MD Ophthalmology
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Apex Eye
    • Cleveland, Ohio, United States, 44115
      • Abrams Eye Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Mark J. Weiss, MD, Inc.
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Assoc
    • Kingston, Pennsylvania, United States, 18704
      • Eye Care Specialists
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care
    • Nashville, Tennessee, United States, 37205
      • Advancing Vision Research
  • Texas
    • Austin, Texas, United States, 78731
      • Texan Eye / Keystone Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AKB-9778 4% QD + Latanoprost; • AKB-9778 4% daily (AM) and placebo for ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days	Drug: Latanoprost ophthalmic solution; Latanoprost opthalmic solution to be dosed once daily; Drug: AKB-9778 4%; Razuprotafib opthalmic solution
Experimental: AKB-9778 4% BID + Latanoprost; • AKB-9778 4% twice daily (AM & PM) plus latanoprost daily (PM) for 28 days	Drug: Latanoprost ophthalmic solution; Latanoprost opthalmic solution to be dosed once daily; Drug: AKB-9778 4%; Razuprotafib opthalmic solution
Placebo Comparator: Placebo Twice Daily + Latanoprost; • Placebo for AKB-9778 4% ophthalmic solution twice daily (AM & PM) plus latanoprost daily (PM) for 28 days	Drug: Latanoprost ophthalmic solution; Latanoprost opthalmic solution to be dosed once daily; Drug: Placebo; placebo for razuprotafib opthalmic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: EyePoint Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2020
• Primary Completion (Actual): November 5, 2020
• Study Completion (Actual): November 5, 2020

Study Registration Dates

• First Submitted: May 23, 2020
• First Submitted That Met QC Criteria: May 23, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Pharmaceutical Solutions; Ophthalmic Solutions; Latanoprost
• Other Study ID Numbers: AKB-9778-CI-OS-2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No