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

May 1, 2023 updated by: EyePoint Pharmaceuticals, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
194

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Intraocular Pressure at Day 28 (Study Eye)
Time Frame: Baseline to Day 28
Change from Baseline in Diurnal Mean IOP (mmHg) at Day 28 in the Study Eye -- ITT Population
Baseline to Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye)
Time Frame: Baseline to Day 14
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)
Time Frame: 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
Baseline to Day 14 and Baseline to Day 28
Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes)
Time Frame: 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
Baseline to Day 14 and Baseline to Day 28
Mean Observed IOP at Each Time Point on Days 14 and 28
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
Baseline to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
EyePoint Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 5, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 5, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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