Next Generation Rocklatan
- 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).
- Short title
- Next Generation Rocklatan
- Official title
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2025-11-14
- First posted
- 2024-06-04
- Registry last updated
- 2025-11-18
- Primary completion date
- 2025-11-14
- Start date
- 2024-09-04
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Alcon Research
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06441643
- ClinicalTrials.gov ID
- NCT06441643
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Mean diurnal IOP at Day 8 (Stage 1)
Timeframe: 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.
Mean diurnal IOP at Day 29 (Stage 2)
Timeframe: 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 IOP at each post-treatment timepoint (Stage 1)
Timeframe: 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 the diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1)
Timeframe: 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 diurnally adjusted baseline IOP at each post-treatment timepoint (Stage 1)
Timeframe: 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 change from baseline mean diurnal IOP at each post-treatment timepoint (Stage 1)
Timeframe: 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 baseline mean diurnal IOP at each post-treatment timepoint (Stage 1)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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 2)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
Stage 1 Key Inclusion Criteria;
- 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.
Stage 2 Key Inclusion Criteria:
- 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 Exclusion Criteria:
- 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.
- Orange County Ophthalmology Medical GroupGarden Grove, United States
- United Medical Research InstituteInglewood, United States
- Eye Research FoundationNewport Beach, United States
- North Bay Eye AssociatesPetaluma, United States
- Eye Center of Northern Colorado, PCFort Collins, United States
- Coastal Research AssociatesRoswell, United States
- Rochester Ophthalmological GroupRochester, United States
- James D. Branch OphthalmologyWinston-Salem, United States
- Scott & Christie and Associates, PCCranberry Township, United States
- University Eye SpecialistsMaryville, United States
- Total Eye Care PAMemphis, United States
- Piedmont Eye CenterLynchburg, United States
Related records
Drugs (3)
Lead sponsors (1)
Conditions (3)
- Glaucoma
- Ocular hypertension
- Open-angle glaucoma Primary condition