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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

Primary Purpose

Ocular Hypertension, Primary Open Angle Glaucoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Latanoprost ophthalmic solution
AKB-9778 4%
Placebo
Sponsored by
EyePoint Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • United Medical Research Institute
  • North Valley Eye Medical Group
  • Eye Research Foundation
  • North Bay Eye Associates
  • Shettle Eye Research
  • Clayton Eye Clinical Research, LLC
  • Coastal Research Associates
  • Kannarr Eye Care
  • Heart of America Eye Care, P.A.
  • Tekwani Vision Center
  • North Valley Eye Medical Group
  • Charlotte Eye, Ear, Nose & Throat Assoc. (CEENTA)
  • James D. Branch, MD Ophthalmology
  • Apex Eye
  • Abrams Eye Center
  • Mark J. Weiss, MD, Inc.
  • Scott & Christie and Assoc
  • Eye Care Specialists
  • Total Eye Care
  • Advancing Vision Research
  • Texan Eye / Keystone Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

AKB-9778 4% QD + Latanoprost

AKB-9778 4% BID + Latanoprost

Placebo Twice Daily + Latanoprost

Arm Description

• AKB-9778 4% daily (AM) and placebo for ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days

• AKB-9778 4% twice daily (AM & PM) plus latanoprost daily (PM) for 28 days

• Placebo for AKB-9778 4% ophthalmic solution twice daily (AM & PM) plus latanoprost daily (PM) for 28 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
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
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
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

Full Information

First Posted
May 23, 2020
Last Updated
May 1, 2023
Sponsor
EyePoint Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04405245
Brief Title
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
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 6, 2020 (Actual)
Primary Completion Date
November 5, 2020 (Actual)
Study Completion Date
November 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EyePoint Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Primary Open Angle Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AKB-9778 4% QD + Latanoprost
Arm Type
Experimental
Arm Description
• AKB-9778 4% daily (AM) and placebo for ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days
Arm Title
AKB-9778 4% BID + Latanoprost
Arm Type
Experimental
Arm Description
• AKB-9778 4% twice daily (AM & PM) plus latanoprost daily (PM) for 28 days
Arm Title
Placebo Twice Daily + Latanoprost
Arm Type
Placebo Comparator
Arm Description
• Placebo for AKB-9778 4% ophthalmic solution twice daily (AM & PM) plus latanoprost daily (PM) for 28 days
Intervention Type
Drug
Intervention Name(s)
Latanoprost ophthalmic solution
Intervention Description
Latanoprost opthalmic solution to be dosed once daily
Intervention Type
Drug
Intervention Name(s)
AKB-9778 4%
Intervention Description
Razuprotafib opthalmic solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo for razuprotafib opthalmic solution
Primary Outcome Measure Information:
Title
Change From Baseline in Intraocular Pressure at Day 28 (Study Eye)
Description
Change from Baseline in Diurnal Mean IOP (mmHg) at Day 28 in the Study Eye -- ITT Population
Time Frame
Baseline to Day 28
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye)
Description
Change from Baseline in Diurnal Mean IOP (mmHg) at Day 14 in the Study Eye -- ITT Population
Time Frame
Baseline to Day 14
Title
Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes)
Description
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
Title
Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes)
Description
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
Title
Mean Observed IOP at Each Time Point on Days 14 and 28
Description
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
Title
Mean Change From Baseline IOP at Each Time Point on Days 14 and 28
Description
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
Title
Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28
Description
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
Title
Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28
Description
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
Title
Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
United Medical Research Institute
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
North Valley Eye Medical Group
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
North Bay Eye Associates
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Shettle Eye Research
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
Clayton Eye Clinical Research, LLC
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Coastal Research Associates
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Kannarr Eye Care
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Heart of America Eye Care, P.A.
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Tekwani Vision Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
North Valley Eye Medical Group
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Charlotte Eye, Ear, Nose & Throat Assoc. (CEENTA)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
James D. Branch, MD Ophthalmology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
Apex Eye
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Abrams Eye Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Mark J. Weiss, MD, Inc.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Scott & Christie and Assoc
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Eye Care Specialists
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Total Eye Care
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Advancing Vision Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Texan Eye / Keystone Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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