Evaluating new eye drops for treating glaucoma and ocular hypertension
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
PHASE2 · Alcon Research · NCT06441643
This study is testing two new eye drops to see if they can safely help people with glaucoma or high eye pressure feel better.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alcon Research (industry) |
| Locations | 12 sites (Garden Grove, California and 11 other locations) |
| Trial ID | NCT06441643 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and effectiveness of two new ophthalmic solutions, AR-17043 and PG043, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). The trial is divided into two stages: the first stage involves approximately 100 participants who will receive different concentrations of AR-17043 or a placebo for 7 days. The second stage will include around 350 participants who will be randomized to receive various formulations, including PG043 and other established treatments, over a 28-day period.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with open-angle glaucoma or ocular hypertension with specific intraocular pressure measurements.
Not a fit: Patients currently using more than two ocular hypotensive medications or those with other types of glaucoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could lead to more effective treatment options for patients suffering from glaucoma and ocular hypertension.
How similar studies have performed: Other studies have shown promise with similar approaches in treating glaucoma, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Garden Grove, California and 11 other locations
- Orange County Ophthalmology Medical Group — Garden Grove, California, United States (NOT_YET_RECRUITING)
- United Medical Research Institute — Inglewood, California, United States (NOT_YET_RECRUITING)
- Eye Research Foundation — Newport Beach, California, United States (RECRUITING)
- North Bay Eye Associates — Petaluma, California, United States (NOT_YET_RECRUITING)
- Eye Center of Northern Colorado, PC — Fort Collins, Colorado, United States (NOT_YET_RECRUITING)
- Coastal Research Associates — Roswell, Georgia, United States (NOT_YET_RECRUITING)
- Rochester Ophthalmological Group — Rochester, New York, United States (NOT_YET_RECRUITING)
- James D. Branch Ophthalmology — Winston-Salem, North Carolina, United States (NOT_YET_RECRUITING)
- Scott & Christie and Associates, PC — Cranberry Township, Pennsylvania, United States (RECRUITING)
- University Eye Specialists — Maryville, Tennessee, United States (NOT_YET_RECRUITING)
- Total Eye Care PA — Memphis, Tennessee, United States (NOT_YET_RECRUITING)
- Piedmont Eye Center — Lynchburg, Virginia, United States (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Alcon Call Center
- Email: alcon.medinfo@alcon.com
- Phone: 1-888-451-3937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Open Angle Glaucoma, Ocular Hypertension, Glaucoma, IOP