A Phase II, Prospective, Two-Stage, Double-Masked, Randomized, Multi-Center, Controlled, Dose-Response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-17043 and PG043 (AR-17043/Latanoprost) Ophthalmic Solutions in Subjects With Elevated Intraocular Pressure

Status: Active_not_recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this two-stage clinical trial is to assess the safety and hypotensive efficacy of AR-17043 and PG043 ophthalmic solutions in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 +1.0 logMAR (Snellen equivalent equal to or better than 20/200) in the study eye.

• Other protocol-specified inclusion criteria may apply.

• 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.

• Other protocol-specified inclusion criteria may apply.

Locations
United States
California
Orange County Ophthalmology Medical Group
Garden Grove
United Medical Research Institute
Inglewood
Eye Research Foundation
Newport Beach
North Bay Eye Associates
Petaluma
Colorado
Eye Center of Northern Colorado, PC
Fort Collins
Georgia
Coastal Research Associates
Roswell
North Carolina
James D. Branch Ophthalmology
Winston-salem
New York
Rochester Ophthalmological Group
Rochester
Pennsylvania
Scott & Christie and Associates, PC
Cranberry Township
Tennessee
University Eye Specialists
Maryville
Total Eye Care PA
Memphis
Virginia
Piedmont Eye Center
Lynchburg
Time Frame
Start Date: 2024-09-04
Completion Date: 2025-11
Participants
Target number of participants: 426
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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.
Placebo_comparator: 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.
Active_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.
Experimental: PG043 low concentration (Stage 2)
PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Experimental: PG043 high concentration (Stage 2)
PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Active_comparator: AR-17043 high concentration (Stage 2)
AR-17043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Active_comparator: Latanoprost (Stage 2)
Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Active_comparator: Rocklatan (Stage 2)
Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
Sponsors
Leads: Alcon Research

This content was sourced from clinicaltrials.gov