Rocklatan® Evaluation

A Multicenter, Open-Label Rocklatan® (Netarsudil/Latanoprost Ophthalmic Solution) 0.02%/0.005% Evaluation of IOP Lowering Efficacy and Safety as Replacement of Current Medical Therapy Regimen for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension

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).

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Drug: Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Mission Hills, California, United States, 91345
      • North Valley Eye Medical Group
    • Newport Beach, California, United States, 92663
      • Visionary Eye Institute
    • Pasadena, California, United States, 91107
      • California Eye Specialists Medical Group
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates
  • Florida
    • Largo, Florida, United States, 33773
      • Shettle Eye Research
    • Venice, Florida, United States, 34285
      • Center For Sight
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Georgia Eye Partners
    • Roswell, Georgia, United States, 30076
      • Coastal Research Associates LLC
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • Tekwani Vision Center
  • New York
    • Manhasset, New York, United States, 11030
      • OCLI Vision
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Mark J. Weiss, MD, Inc.
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Associates, PC
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Advancing Vision Research
    • Memphis, Tennessee, United States, 38120
      • VRF Eye Specialty Group
    • Memphis, Tennessee, United States, 38199
      • Total Eye Care, PA
  • Texas
    • Austin, Texas, United States, 78731
      • Keystone Research
    • El Paso, Texas, United States, 79902
      • Louis M. Alpern, M.D., M.P.H., P.A
    • Houston, Texas, United States, 77025
      • Houston Eye Associates
  • Virginia
    • Falls Church, Virginia, United States, 22046
      • Emerson Clinical Research Institute
    • Roanoke, Virginia, United States, 24016
      • Vistar Eye Center
  • Wisconsin
    • Racine, Wisconsin, United States, 53405
      • The Eye Centers of Racine and Kenosha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 2 additional agents/bottles. Current IOP lowering regimen is stable for at least 30 days prior to Baseline Visit
• Treated IOP ≥ 20 mmHg measured in the morning (before noon) at the Baseline Visit by Goldmann applanation tonometer
• Best corrected Snellen visual acuity of 20/100 or better in both eyes
• Willingness to follow protocol requirements, including signed informed consent and health information release forms, routine follow-up schedule, completing questionnaires

Key Exclusion Criteria:

• Have any active ocular disease other than open-angle glaucoma or ocular hypertension that would interfere with study interpretation
• Use of fixed dose combination agents as part of the patient's Baseline IOP lowering therapy 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 known risk factors for macular edema
• Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results
• Use of topical, periorbital, intravitreal or systemic steroid within previous 3 months or expected use during the course of the study
• Prior participation in any investigational drug or device study within the last 30 days 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 birth control

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rocklatan; Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks	Drug: Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution; Commercially available ophthalmic solution indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension; Other Names: Rocklatan®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Change From Baseline in Intraocular Pressure (IOP) at Week 12	IOP was measured using Goldmann applanation tonometry at the Baseline and Week 12 visits. One eye (study eye) contributed data to this analysis. A negative value indicates an improvement in IOP. No hypothesis testing was prespecified for this endpoint.	Baseline (Day 0 pretreatment), Week 12

Collaborators and Investigators

• Sponsor: Aerie Pharmaceuticals
• Investigators: Study Director: Scientific Advisor, Clinical R&D, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): March 22, 2023
• Study Completion (Actual): March 22, 2023

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Pharmaceutical Solutions; Ophthalmic Solutions; Latanoprost
• Other Study ID Numbers: MA-ROC-22-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No