Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
426 participants
INTERVENTIONAL
2024-09-04
2025-11-14
Brief Summary
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Detailed Description
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During Stage 2, approximately 350 adult subjects with OAG or OHT will be randomized to 5 arms: low and high concentrations of PG043 (AR-17043/latanoprost 0.005%), AR-17043 high concentration, latanoprost, or netarsudil 0.02%/latanoprost 0.005% (Rocklatan®) for a treatment duration of 28 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AR-17043 low concentration (Stage 1)
AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
AR-17043 Ophthalmic Solution
Investigational monotherapy supplied in three concentration levels: low, medium, high
AR-17043 medium concentration (Stage 1)
AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
AR-17043 Ophthalmic Solution
Investigational monotherapy supplied in three concentration levels: low, medium, high
AR-17043 high concentration (Stage 1)
AR-17043 Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
AR-17043 Ophthalmic Solution
Investigational monotherapy supplied in three concentration levels: low, medium, high
AR-17043 vehicle (Stage 1)
AR-17043 Vehicle, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
AR-17043 Vehicle
Placebo comparator
Rhopressa (Stage 1)
Netarsudil 0.02% Ophthalmic Solution, one drop in each eye in the morning on Day 1, followed by one drop in each eye in the evening on Days 2-7.
Netarsudil 0.02% Ophthalmic Solution
Marketed monotherapy
PG043 low concentration (Stage 2)
PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
PG043 Ophthalmic Solution
Investigational fixed dose combination supplied in two concentration levels: low and high
PG043 high concentration (Stage 2)
PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
PG043 Ophthalmic Solution
Investigational fixed dose combination supplied in two concentration levels: low and high
AR-17043 high concentration (Stage 2)
AR-17043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
AR-17043 Ophthalmic Solution
Investigational monotherapy supplied in three concentration levels: low, medium, high
Latanoprost (Stage 2)
Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Latanoprost 0.005% Ophthalmic Solution
Marketed monotherapy
Rocklatan (Stage 2)
Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution
Marketed fixed dose combination
Interventions
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AR-17043 Ophthalmic Solution
Investigational monotherapy supplied in three concentration levels: low, medium, high
PG043 Ophthalmic Solution
Investigational fixed dose combination supplied in two concentration levels: low and high
Latanoprost 0.005% Ophthalmic Solution
Marketed monotherapy
Netarsudil 0.02% Ophthalmic Solution
Marketed monotherapy
Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution
Marketed fixed dose combination
AR-17043 Vehicle
Placebo comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* High unmedicated IOP measurements in the study eye as specified in the protocol.
* Corrected visual acuity equal to or better than +1.0 logMAR (Snellen equivalent equal to or better than 20/200) in the study eye.
* Diagnosis of OAG or OHT in both eyes.
* High unmedicated IOP measurements in the study eye as specified in the protocol.
* Corrected visual acuity equal to or better than +0.7 logMAR (Snellen equivalent equal to or better than 20/100) in the study eye.
Exclusion Criteria
* Intraocular pressure greater than 36 millimeters mercury (mmHg) at Screening.
* Glaucoma other than OAG.
* Previous glaucoma surgery.
* Any abnormality preventing reliable measurements.
* Unable to demonstrate proper eyedrop instillation.
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Lead, Pharma
Role: STUDY_DIRECTOR
Alcon Research, LLC
Locations
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Orange County Ophthalmology Medical Group
Garden Grove, California, United States
United Medical Research Institute
Inglewood, California, United States
Eye Research Foundation
Newport Beach, California, United States
North Bay Eye Associates
Petaluma, California, United States
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, United States
Coastal Research Associates
Roswell, Georgia, United States
Rochester Ophthalmological Group
Rochester, New York, United States
James D. Branch Ophthalmology
Winston-Salem, North Carolina, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States
University Eye Specialists
Maryville, Tennessee, United States
Total Eye Care PA
Memphis, Tennessee, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
Countries
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Other Identifiers
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GLR305-E001
Identifier Type: -
Identifier Source: org_study_id
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