Rocklatan® Evaluation

Last updated: March 8, 2024
Sponsor: Aerie Pharmaceuticals
Overall Status: Completed

Phase

4

Condition

Glaucoma

Treatment

Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution

Clinical Study ID

NCT05283395
MA-ROC-22-003
  • Ages > 18
  • All Genders

Study Summary

The objective of this study is to evaluate the IOP-lowering effect when subjects are switched from various latanoprost-based regimens to Rocklatan. Subjects will stop their IOP-lowering medical therapy regimen and dose with Rocklatan for the duration of the study (12 weeks).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Male or female subjects age 18 or older
  • Current diagnosis of open-angle glaucoma or ocular hypertension
  • Subject currently being treated with latanoprost alone or latanoprost plus 1 or 2additional agents/bottles. Current IOP lowering regimen is stable for at least 30 daysprior to Baseline Visit
  • Treated IOP ≥ 20 mmHg measured in the morning (before noon) at the Baseline Visit byGoldmann applanation tonometer
  • Best corrected Snellen visual acuity of 20/100 or better in both eyes
  • Willingness to follow protocol requirements, including signed informed consent andhealth information release forms, routine follow-up schedule, completingquestionnaires

Exclusion

Key Exclusion Criteria:

  • Have any active ocular disease other than open-angle glaucoma or ocular hypertensionthat would interfere with study interpretation
  • Use of fixed dose combination agents as part of the patient's Baseline IOP loweringtherapy regimen, if not also on latanoprost
  • Active ocular infection/inflammation or history of uveitis
  • Aphakic or pseudophakic patients with a torn posterior lens capsule, or with knownrisk factors for macular edema
  • Any systemic disease or clinical evidence of any condition which would make thesubject, in the opinion of the investigator, unsuitable for the study or couldpotentially confound the study results
  • Use of topical, periorbital, intravitreal or systemic steroid within previous 3 monthsor expected use during the course of the study
  • Prior participation in any investigational drug or device study within the last 30days prior to the Baseline Visit.
  • Known sensitivity or allergy to the study medication or components
  • Females who are pregnant, nursing, or planning a pregnancy during the study
  • Positive pregnancy test at Baseline Visit (women of childbearing potential only)
  • Women of childbearing potential who are not using a medically acceptable form of birthcontrol

Study Design

Total Participants: 136
Treatment Group(s): 1
Primary Treatment: Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution
Phase: 4
Study Start date:
March 28, 2022
Estimated Completion Date:
March 22, 2023

Study Description

Enrollment will be stratified according to subject's IOP-lowering medical therapy regimen as follows:

  • Latanoprost monotherapy (Latanoprost Mono)

  • Latanoprost plus 1 additional IOP-lowering agent (Latanoprost +1)

  • Latanoprost plus 2 additional IOP-lowering agents (Latanoprost +2)

Aerie Pharmaceuticals was acquired by Alcon Research LLC on November 22, 2022.

Connect with a study center

  • North Valley Eye Medical Group

    Mission Hills, California 91345
    United States

    Site Not Available

  • Visionary Eye Institute

    Newport Beach, California 92663
    United States

    Site Not Available

  • California Eye Specialists Medical Group

    Pasadena, California 91107
    United States

    Site Not Available

  • North Bay Eye Associates

    Petaluma, California 94954
    United States

    Site Not Available

  • Shettle Eye Research

    Largo, Florida 33773
    United States

    Site Not Available

  • Center For Sight

    Venice, Florida 34285
    United States

    Site Not Available

  • Georgia Eye Partners

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Coastal Research Associates LLC

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Tekwani Vision Center

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • OCLI Vision

    Manhasset, New York 11030
    United States

    Site Not Available

  • Mark J. Weiss, MD, Inc.

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Scott & Christie and Associates, PC

    Cranberry Township, Pennsylvania 16066
    United States

    Site Not Available

  • Advancing Vision Research

    Goodlettsville, Tennessee 37072
    United States

    Site Not Available

  • Total Eye Care, PA

    Memphis, Tennessee 38199
    United States

    Site Not Available

  • VRF Eye Specialty Group

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Keystone Research

    Austin, Texas 78731
    United States

    Site Not Available

  • Louis M. Alpern, M.D., M.P.H., P.A

    El Paso, Texas 79902
    United States

    Site Not Available

  • Houston Eye Associates

    Houston, Texas 77025
    United States

    Site Not Available

  • Emerson Clinical Research Institute

    Falls Church, Virginia 22046
    United States

    Site Not Available

  • Vistar Eye Center

    Roanoke, Virginia 24016
    United States

    Site Not Available

  • The Eye Centers of Racine and Kenosha

    Racine, Wisconsin 53405
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.