Clinical trial 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
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ocular Hypertension
Primary Open Angle Glaucoma
Lead sponsor: EyePoint Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-05-28
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Intraocular Pressure at Day 28 (Study Eye)
timeFrame: Baseline to Day 28
Secondary outcomes:
measure: Mean Change From Baseline in Diurnal Mean IOP at the Day 14 Visit (Study Eye)
timeFrame: Baseline to Day 14
measure: Mean Change From Baseline in Diurnal Mean IOP on Days 14 and 28 (Both Eyes)
timeFrame: Baseline to Day 14 and Baseline to Day 28
measure: Observed Mean Diurnal Mean IOP on Days 14 and 28 (Both Eyes)
timeFrame: Baseline to Day 14 and Baseline to Day 28
measure: Mean Observed IOP at Each Time Point on Days 14 and 28
timeFrame: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28
measure: Mean Change From Baseline IOP at Each Time Point on Days 14 and 28
timeFrame: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28
measure: Mean Percent Change From Diurnally Adjusted Baseline IOP at Each Time Point on Days 14 and 28
timeFrame: Baseline to each timepoint on Day 14 and Baseline to each timepoint on Day 28
measure: Mean Percent Change From Baseline in Diurnal Mean IOP on Days 14 and 28
timeFrame: Baseline to Day 14 and Baseline to Day 28
measure: Percentages of Subjects Achieving Pre-Specified Mean, Mean Change, and Percent Mean Change in Diurnal Mean IOP Levels
timeFrame: Baseline to Day 28
Other outcomes:
Locations:
city: Inglewood
country: United States
facility: United Medical Research Institute
state: California
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: Largo
country: United States
facility: Shettle Eye Research
state: Florida
city: Morrow
country: United States
facility: Clayton Eye Clinical Research, LLC
state: Georgia
city: Roswell
country: United States
facility: Coastal Research Associates
state: Georgia
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Shawnee Mission
country: United States
facility: Heart of America Eye Care, P.A.
state: Kansas
city: Saint Louis
country: United States
facility: Tekwani Vision Center
state: Missouri
city: Rochester
country: United States
facility: North Valley Eye Medical Group
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose & Throat Assoc. (CEENTA)
state: North Carolina
city: Winston-Salem
country: United States
facility: James D. Branch, MD Ophthalmology
state: North Carolina
city: Cincinnati
country: United States
facility: Apex Eye
state: Ohio
city: Cleveland
country: United States
facility: Abrams Eye Center
state: Ohio
city: Tulsa
country: United States
facility: Mark J. Weiss, MD, Inc.
state: Oklahoma
city: Cranberry Township
country: United States
facility: Scott & Christie and Assoc
state: Pennsylvania
city: Kingston
country: United States
facility: Eye Care Specialists
state: Pennsylvania
city: Memphis
country: United States
facility: Total Eye Care
state: Tennessee
city: Nashville
country: United States
facility: Advancing Vision Research
state: Tennessee
city: Austin
country: United States
facility: Texan Eye / Keystone Research
state: Texas
Study officials:
References: