Trial Information
Current as of February 19, 2025
Recruiting
Keywords
ClinConnect Summary
The Next Generation Rocklatan clinical trial is studying two eye drop medications, AR-17043 and PG043, to see how safe they are and how well they can lower eye pressure in people with open-angle glaucoma (OAG) or ocular hypertension (OHT). This trial is in its second phase and is currently looking for participants aged between 65 and 74 years. To be eligible for the trial, participants must have a diagnosis of OAG or OHT in both eyes and high eye pressure measurements without current medication. Additionally, they need to have a certain level of vision in the study eye.
If you choose to participate, you will be assessed for your eye health and medical history to ensure you meet the criteria. Throughout the trial, you will receive the study eye drops and regular check-ups to monitor your eye pressure and overall safety. It’s important to note that those currently using more than two eye pressure-lowering medications or who have had previous glaucoma surgery may not be eligible. This study aims to find effective new treatments to help manage eye pressure for individuals with glaucoma and ocular hypertension.
Gender
ALL
Eligibility 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.
Trial Officials
Clinical Trial Lead, Pharma
Study Director
Alcon Research, LLC
About Alcon Research
Alcon Research is a leading global company dedicated to advancing eye care through innovative research and development. As a subsidiary of Novartis, Alcon focuses on the development of cutting-edge products and therapies for vision correction and eye health, including surgical, pharmaceutical, and consumer eye care solutions. With a commitment to enhancing the quality of life for patients worldwide, Alcon Research conducts rigorous clinical trials to evaluate the safety and efficacy of its products, ensuring that they meet the highest standards of care. Through collaboration with healthcare professionals and institutions, Alcon remains at the forefront of ophthalmic advancements, driving progress in the field of vision science.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Petaluma, California, United States
Inglewood, California, United States
Rochester, New York, United States
Newport Beach, California, United States
Roswell, Georgia, United States
Cranberry Township, Pennsylvania, United States
Lynchburg, Virginia, United States
Maryville, Tennessee, United States
Memphis, Tennessee, United States
Garden Grove, California, United States
Winston Salem, North Carolina, United States
Fort Collins, Colorado, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0