COMPLETED

Next Generation Rocklatan

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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

Quick Facts

Study Start:2024-09-04
Study Completion:2025-11-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06441643

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of OAG or OHT in both eyes.
  2. * High unmedicated IOP measurements in the study eye as specified in the protocol.
  3. * Corrected visual acuity equal to or better than +0.7 logMAR (Snellen equivalent equal to or better than 20/100) in the study eye.
  4. * Other protocol-specified inclusion criteria may apply.
  1. * Current use of more than 2 ocular hypotensive medications within 30 days (either eye).
  2. * Intraocular pressure greater than 36 millimeters mercury (mmHg) at Screening.
  3. * Glaucoma other than OAG.
  4. * Previous glaucoma surgery.
  5. * Any abnormality preventing reliable measurements.
  6. * Unable to demonstrate proper eyedrop instillation.
  7. * Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Principal Investigator

Clinical Trial Lead, Pharma
STUDY_DIRECTOR
Alcon Research, LLC

Study Locations (Sites)

Orange County Ophthalmology Medical Group
Garden Grove, California, 92843
United States
United Medical Research Institute
Inglewood, California, 90301
United States
Eye Research Foundation
Newport Beach, California, 92663
United States
North Bay Eye Associates
Petaluma, California, 94954
United States
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, 80528
United States
Coastal Research Associates
Roswell, Georgia, 30076
United States
Rochester Ophthalmological Group
Rochester, New York, 14618
United States
James D. Branch Ophthalmology
Winston-Salem, North Carolina, 27101
United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066
United States
University Eye Specialists
Maryville, Tennessee, 37803
United States
Total Eye Care PA
Memphis, Tennessee, 38119
United States
Piedmont Eye Center
Lynchburg, Virginia, 24502
United States

Collaborators and Investigators

Sponsor: Alcon Research

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-04
Study Completion Date2025-11-14

Study Record Updates

Study Start Date2024-09-04
Study Completion Date2025-11-14

Terms related to this study

Keywords Provided by Researchers

  • Glaucoma
  • IOP

Additional Relevant MeSH Terms

  • Open Angle Glaucoma
  • Ocular Hypertension