Rocklatan® Evaluation

Phase 4

Completed

• Conditions: Glaucoma
• Interventions: Drug: Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution

• Registration Number: NCT05283395
• Lead Sponsor: Aerie Pharmaceuticals

Brief 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).

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 Timeline

• Study First Submitted: 2022-03-07
• Study First Submitted QC: 2022-03-14
• Study First Posted: 2022-03-17
• Study Start: 2022-03-28
• Primary Completion: 2023-03-22
• Study Completion: 2023-03-22
• Status Verified: 2024-01
• Results First Submitted: 2024-03-08
• Results First Submitted QC: 2024-03-08
• Last Update Submitted: 2024-03-08
• Results First Posted: 2024-04-03
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rocklatan	Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution	Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks

Primary Outcome Measures

Name	Time	Method
Mean Percent Change From Baseline in Intraocular Pressure (IOP) at Week 12	Baseline (Day 0 pretreatment), 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.

Trial Locations

Locations (21)

Keystone Research; 🇺🇸 Austin, Texas, United States

Total Eye Care, PA; 🇺🇸 Memphis, Tennessee, United States

North Valley Eye Medical Group; 🇺🇸 Mission Hills, California, United States

Visionary Eye Institute; 🇺🇸 Newport Beach, California, United States

California Eye Specialists Medical Group; 🇺🇸 Pasadena, California, United States

North Bay Eye Associates; 🇺🇸 Petaluma, California, United States

Georgia Eye Partners; 🇺🇸 Atlanta, Georgia, United States

OCLI Vision; 🇺🇸 Manhasset, New York, United States

Coastal Research Associates LLC; 🇺🇸 Roswell, Georgia, United States

Tekwani Vision Center; 🇺🇸 Saint Louis, Missouri, United States

Mark J. Weiss, MD, Inc.; 🇺🇸 Tulsa, Oklahoma, United States

Houston Eye Associates; 🇺🇸 Houston, Texas, United States

Scott & Christie and Associates, PC; 🇺🇸 Cranberry Township, Pennsylvania, United States

Louis M. Alpern, M.D., M.P.H., P.A; 🇺🇸 El Paso, Texas, United States

Emerson Clinical Research Institute; 🇺🇸 Falls Church, Virginia, United States

Vistar Eye Center; 🇺🇸 Roanoke, Virginia, United States

Advancing Vision Research; 🇺🇸 Goodlettsville, Tennessee, United States

VRF Eye Specialty Group; 🇺🇸 Memphis, Tennessee, United States

Shettle Eye Research; 🇺🇸 Largo, Florida, United States

Center For Sight; 🇺🇸 Venice, Florida, United States

The Eye Centers of Racine and Kenosha; 🇺🇸 Racine, Wisconsin, United States