Efficacy and Safety Assessment of T4090 Ophthalmic Solution Versus Rhopressa® Ophthalmic Solution in Patients with Open-angle Glaucoma or Ocular Hypertension

Last updated: October 2, 2024
Sponsor: Laboratoires Thea
Overall Status: Active - Not Recruiting

Phase

2

Condition

Stress

Circulation Disorders

Williams Syndrome

Treatment

T4090 0.3%

Rhopressa®

T4090 0.2%

Clinical Study ID

NCT06394973
LT4090-201
  • Ages > 18
  • All Genders

Study Summary

The main purpose is to compare the ocular hypotensive efficacy and safety of two concentrations of T4090 (Kinezodianone R HCl 0.2% and 0.3%) ophthalmic solution with Rhopressa® ophthalmic solution

Eligibility Criteria

Inclusion

Main Inclusion Criteria:

  • Patient (male or female) ≥18 years old

  • Patient with Open Angle Glaucoma or Ocular Hypertension in both eyes

  • Informed consent dated and signed.

Exclusion

Main Exclusion Criteria:

  • Secondary Open Agle Glaucoma (ex. Pseudoexfoliation, Pigmentary glaucoma)

  • Advanced stage of glaucoma

  • History of ocular trauma, eye infection, or/and ocular clinically significantinflammation within the 6 previous months.

  • Known or suspected hypersensitivity to one of the components of the IMPs or otherproduct used in the clinical study

  • Pregnancy (confirmed with a positive urine pregnancy test) or breast-feeding.

Study Design

Total Participants: 126
Treatment Group(s): 3
Primary Treatment: T4090 0.3%
Phase: 2
Study Start date:
August 05, 2024
Estimated Completion Date:
May 31, 2025

Connect with a study center

  • Arizona Advanced Eye Research Institute

    Glendale, Arizona 85306
    United States

    Site Not Available

  • Global Research Management, Inc.

    Glendale, California 91204
    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

    Site Not Available

  • Visionary Research Institute

    Newport Beach, California 92663
    United States

    Site Not Available

  • North Bay Eye Associates

    Petaluma, California 94954
    United States

    Site Not Available

  • Sacramento Eye Consultants, A Medical Corporation

    Sacramento, California 95815
    United States

    Site Not Available

  • Wolstan and Goldberg Eye Associates

    Torrance, California 90505
    United States

    Site Not Available

  • Segal Drug Trials, Inc

    Delray Beach, Florida 33484
    United States

    Site Not Available

  • East Coast Institute for Research, LLC

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Shettle Eye Research, Inc.

    Largo, Florida 33773
    United States

    Site Not Available

  • Mild Florida Eye Center

    Mount Dora, Florida 32757
    United States

    Site Not Available

  • Coastal Research Associates, LLC

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Seidenberg Protzko Eye Associates

    Havre De Grace, Maryland 21078
    United States

    Site Not Available

  • Alterman, Modi and Wolter Ophthalmic Surgeons

    Poughkeepsie, New York 12603
    United States

    Site Not Available

  • James D. Branch, MD

    Winston-Salem, North Carolina 27101
    United States

    Site Not Available

  • Total Eye Care, PA

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Keystone Research

    Austin, Texas 78731
    United States

    Site Not Available

  • Glaucoma Associates of Texas

    Dallas, Texas 75231
    United States

    Site Not Available

  • Houston Eye Associates

    Houston, Texas 53719
    United States

    Site Not Available

  • DCT-Shah Research, LLC sba Discovery Clinical Trials

    Mission, Texas 78572
    United States

    Site Not Available

  • Emerson Clinical Research Institute

    Falls Church, Virginia 22046
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg, Virginia 24502
    United States

    Site Not Available

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