CompletedPhase 2

Next Generation Rocklatan

United States426 participantsStarted 2024-09-04

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Mean diurnal IOP at Day 8 (Stage 1)

Timeframe: Day 8 (8:00, 10:00, 12:00, 16:00)

Mean diurnal IOP at Day 29 (Stage 2)

Timeframe: Day 29 (8:00, 10:00, 16:00)

Trial details

NCT IDNCT06441643

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-14

View on ClinicalTrials.gov More Open Angle Glaucoma trials