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OpenTrials
Completed

NCT Number: NCT04405245

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

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.

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Key information

Conditions

Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Primary Open Angle Glaucoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

United Medical Research Institute, Inglewood, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Latanoprost ophthalmic solution

Drug

Latanoprost opthalmic solution to be dosed once daily

AKB-9778 4%

Drug

Razuprotafib opthalmic solution

Placebo

Drug

placebo for razuprotafib opthalmic solution

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

EyePoint Pharmaceuticals, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 28, 2020
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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