Next Generation Rocklatan

Description

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).

Conditions

Open Angle Glaucoma, Ocular Hypertension

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Study Overview

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Study Details

Study overview

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).

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

Next Generation Rocklatan

Condition
Open Angle Glaucoma
Intervention / Treatment

-

Contacts and Locations

Garden Grove

Orange County Ophthalmology Medical Group, Garden Grove, California, United States, 92843

Inglewood

United Medical Research Institute, Inglewood, California, United States, 90301

Newport Beach

Eye Research Foundation, Newport Beach, California, United States, 92663

Petaluma

North Bay Eye Associates, Petaluma, California, United States, 94954

Fort Collins

Eye Center of Northern Colorado, PC, Fort Collins, Colorado, United States, 80528

Roswell

Coastal Research Associates, Roswell, Georgia, United States, 30076

Rochester

Rochester Ophthalmological Group, Rochester, New York, United States, 14618

Winston-Salem

James D. Branch Ophthalmology, Winston-Salem, North Carolina, United States, 27101

Cranberry Township

Scott & Christie and Associates, PC, Cranberry Township, Pennsylvania, United States, 16066

Maryville

University Eye Specialists, Maryville, Tennessee, United States, 37803

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alcon Research,

Clinical Trial Lead, Pharma, STUDY_DIRECTOR, Alcon Research, LLC

Study Record Dates

2025-11