Next Generation Rocklatan

Last updated: September 16, 2024
Sponsor: Alcon Research
Overall Status: Active - Recruiting

Phase

2

Condition

Ocular Hypertension

Glaucoma

Open Angle Glaucoma

Treatment

Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution

AR-17043 Vehicle

AR-17043 Ophthalmic Solution

Clinical Study ID

NCT06441643
GLR305-E001
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 equivalentequal 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 equivalentequal to or better than 20/100) in the study eye.

  • Other protocol-specified inclusion criteria may apply.

Exclusion

Stage 1 and Stage 2 Key Exclusion Criteria:

  • Current use of more than 2 ocular hypotensive medications within 30 days (eithereye).

  • 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.

Study Design

Total Participants: 450
Treatment Group(s): 6
Primary Treatment: Netarsudil 0.02%/Latanoprost 0.005% Ophthalmic Solution
Phase: 2
Study Start date:
September 04, 2024
Estimated Completion Date:
November 30, 2025

Study Description

During Stage 1, approximately 100 adult subjects with OAG or OHT will be randomized to 5 arms: 3 different concentrations of AR-17043, placebo comparator, or netarsudil 0.02% (Rhopressa®) for a treatment duration of 7 days.

During Stage 2, approximately 350 adult subjects with OAG or OHT will be randomized to 5 arms: low and high concentrations of PG043 (AR-17043/latanoprost 0.005%), AR-17043 high concentration, latanoprost, or netarsudil 0.02%/latanoprost 0.005% (Rocklatan®) for a treatment duration of 28 days.

Connect with a study center

  • Orange County Ophthalmology Medical Group

    Garden Grove, California 92843
    United States

    Site Not Available

  • United Medical Research Institute

    Inglewood, California 90301
    United States

    Site Not Available

  • Eye Research Foundation

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • North Bay Eye Associates

    Petaluma, California 94954
    United States

    Site Not Available

  • Eye Center of Northern Colorado, PC

    Fort Collins, Colorado 80528
    United States

    Site Not Available

  • Coastal Research Associates

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Rochester Ophthalmological Group

    Rochester, New York 14618
    United States

    Site Not Available

  • James D. Branch Ophthalmology

    Winston-Salem, North Carolina 27101
    United States

    Site Not Available

  • Scott & Christie and Associates, PC

    Cranberry Township, Pennsylvania 16066
    United States

    Active - Recruiting

  • University Eye Specialists

    Maryville, Tennessee 37803
    United States

    Site Not Available

  • Total Eye Care PA

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg, Virginia 24502
    United States

    Site Not Available

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