Clinical trial

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

Name

GLR305-E001

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).

Trial arms

Trial start

2024-09-01

Estimated PCD

2025-11-01

Trial end

2025-11-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

AR-17043 Ophthalmic Solution

Investigational monotherapy supplied in three concentration levels: low, medium, high

Arms:

AR-17043 high concentration (Stage 1), AR-17043 high concentration (Stage 2), AR-17043 low concentration (Stage 1), AR-17043 medium concentration (Stage 1)

PG043 Ophthalmic Solution

Investigational fixed dose combination supplied in two concentration levels: low and high

Arms:

PG043 high concentration (Stage 2), PG043 low concentration (Stage 2)

Latanoprost 0.005% Ophthalmic Solution

Marketed monotherapy

Arms:

Latanoprost (Stage 2)

Other names:

Latanoprost

Netarsudil 0.02% Ophthalmic Solution

Marketed monotherapy

Arms:

Rhopressa (Stage 1)

Other names:

Rhopressa®

Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution

Marketed fixed dose combination

Arms:

Rocklatan (Stage 2)

Other names:

Rocklatan®

AR-17043 Vehicle

Placebo comparator

Arms:

AR-17043 vehicle (Stage 1)

Size

450

Primary endpoint

Mean diurnal IOP at Day 8 (Stage 1)

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

Mean diurnal IOP at Day 29 (Stage 2)

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

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 450, 'type': 'ESTIMATED'}}

Updated at

2024-06-04

1 organization

5 products

2 indications

Organization

Alcon Research

Product

AR-17043

Indication

Glaucoma

Indication