Next Generation Rocklatan
- Conditions
- Open Angle GlaucomaOcular Hypertension
- Interventions
- Drug: AR-17043 Ophthalmic SolutionDrug: AR-17043 VehicleDrug: PG043 Ophthalmic Solution
- Registration Number
- NCT06441643
- Lead Sponsor
- Alcon Research
- Brief 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).
- Detailed Description
During Stage 1, approximately 100 adult subjects with OAG or OHT will be randomized to 5 arms: 3 different concentrations of AR-17043, placebo comparator, or netarsudil 0.02% (Rhopressa®) for a treatment duration of 7 days.
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 450
- 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.
Stage 1 and Stage 2 Key
- Current use of more than 2 ocular hypotensive medications within 30 days (either eye).
- 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.
- Other protocol-specified exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AR-17043 low concentration (Stage 1) AR-17043 Ophthalmic Solution 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 medium concentration (Stage 1) AR-17043 Ophthalmic Solution 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 high concentration (Stage 1) AR-17043 Ophthalmic Solution 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 vehicle (Stage 1) AR-17043 Vehicle 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. Rhopressa (Stage 1) Netarsudil 0.02% Ophthalmic Solution 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. PG043 low concentration (Stage 2) PG043 Ophthalmic Solution PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28. PG043 high concentration (Stage 2) PG043 Ophthalmic Solution PG043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28. AR-17043 high concentration (Stage 2) AR-17043 Ophthalmic Solution AR-17043 Ophthalmic Solution, one drop in each eye in the evening on Days 1-28. Latanoprost (Stage 2) Latanoprost 0.005% Ophthalmic Solution Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28. Rocklatan (Stage 2) Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution, one drop in each eye in the evening on Days 1-28.
- Primary Outcome Measures
Name Time Method Mean diurnal IOP at Day 29 (Stage 2) Day 29 (8:00, 10:00, 16:00) Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the three measurements.
Mean diurnal IOP at Day 8 (Stage 1) Day 8 (8:00, 10:00, 12:00, 16:00) Intraocular pressure (IOP) will be measured with a Goldmann tonometer. Diurnal IOP will be calculated as the average of the four measurements.
- Secondary Outcome Measures
Name Time Method Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1) Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00) Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.
Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1) Baseline (8:00, 10:00, 12:00, 16:00); Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00) Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the four baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.
Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2) Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00) Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.
Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2) Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00) Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the three baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.
Mean percent change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 2) Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00) Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the three baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.
Mean IOP at each post-treatment timepoint (Stage 1) Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00) Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint.
Mean change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1) Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00) Intraocular pressure (IOP) will be measured with a Goldmann tonometer. The baseline mean diurnal IOP will be calculated as the average of the four baseline measurements. Baseline is defined as the last visit prior to initiation of treatment.
Mean IOP at each post-treatment timepoint (Stage 2) Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00) Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint.
Mean change from the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 2) Baseline (8:00, 10:00, 16:00); Day 8 (8:00, 10:00, 16:00); Day 15 (8:00, 10:00, 16:00); Day 29 (8:00, 10:00, 16:00) Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.
Mean percent change from diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1) Baseline (8:00, 10:00, 12:00, 16:00), Day 1 (8:00, 10:00, 12:00), Day 8 (8:00, 10:00, 12:00, 16:00) Intraocular pressure (IOP) will be measured with a Goldmann tonometer at each post-treatment timepoint and compared to the time-relevant (corresponding) baseline measurement. Baseline is defined as the last visit prior to initiation of treatment.
Trial Locations
- Locations (12)
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