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)
1 other identifier
interventional
194
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2020
Shorter than P25 for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2020
CompletedFirst Posted
Study publicly available on registry
May 28, 2020
CompletedStudy Start
First participant enrolled
June 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2020
CompletedResults Posted
Study results publicly available
May 25, 2023
CompletedMay 25, 2023
May 1, 2023
5 months
May 23, 2020
September 21, 2022
May 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye)
Baseline to Day 14
Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes)
Baseline to Day 14 and Baseline to Day 28
Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes)
Baseline to Day 14 and Baseline to Day 28
Mean Observed IOP at Each Time Point on Days 14 and 28
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
Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28
- +3 more secondary outcomes
Study Arms (3)
AKB-9778 4% QD + Latanoprost
EXPERIMENTAL• AKB-9778 4% daily (AM) and placebo for ophthalmic solution daily (PM) plus latanoprost daily (PM) for 28 days
AKB-9778 4% BID + Latanoprost
EXPERIMENTAL• AKB-9778 4% twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days
Placebo Twice Daily + Latanoprost
PLACEBO COMPARATOR• Placebo for AKB-9778 4% ophthalmic solution twice daily (AM \& PM) plus latanoprost daily (PM) for 28 days
Interventions
Latanoprost opthalmic solution to be dosed once daily
Razuprotafib opthalmic solution
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
United Medical Research Institute
Inglewood, California, 90301, United States
North Valley Eye Medical Group
Mission Hills, California, 91345, United States
Eye Research Foundation
Newport Beach, California, 92663, United States
North Bay Eye Associates
Petaluma, California, 94954, United States
Shettle Eye Research
Largo, Florida, 33773, United States
Clayton Eye Clinical Research, LLC
Morrow, Georgia, 30260, United States
Coastal Research Associates
Roswell, Georgia, 30076, United States
Kannarr Eye Care
Pittsburg, Kansas, 66762, United States
Heart of America Eye Care, P.A.
Shawnee Mission, Kansas, 66204, United States
Tekwani Vision Center
St Louis, Missouri, 63128, United States
North Valley Eye Medical Group
Rochester, New York, 14618, United States
Charlotte Eye, Ear, Nose & Throat Assoc. (CEENTA)
Charlotte, North Carolina, 28210, United States
James D. Branch, MD Ophthalmology
Winston-Salem, North Carolina, 27101, United States
Apex Eye
Cincinnati, Ohio, 45242, United States
Abrams Eye Center
Cleveland, Ohio, 44115, United States
Mark J. Weiss, MD, Inc.
Tulsa, Oklahoma, 74104, United States
Scott & Christie and Assoc
Cranberry Township, Pennsylvania, 16066, United States
Eye Care Specialists
Kingston, Pennsylvania, 18704, United States
Total Eye Care
Memphis, Tennessee, 38119, United States
Advancing Vision Research
Nashville, Tennessee, 37205, United States
Texan Eye / Keystone Research
Austin, Texas, 78731, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Bauer
- Organization
- EyePoint Pharmaceuticals, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2020
First Posted
May 28, 2020
Study Start
June 6, 2020
Primary Completion
November 5, 2020
Study Completion
November 5, 2020
Last Updated
May 25, 2023
Results First Posted
May 25, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share