Rocklatan® Evaluation

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05283395
• Other study ID #: MA-ROC-22-003
• Status: Completed
• Phase: Phase 4
• Start date: March 28, 2022
• Est. completion date: March 22, 2023

Study information

• Verified date: January 2024
• Source: Aerie Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: March 22, 2023
• Est. primary completion date: March 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

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

Locations

Country	Name	City	State
United States	Georgia Eye Partners	Atlanta	Georgia
United States	Keystone Research	Austin	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	Advancing Vision Research	Goodlettsville	Tennessee
United States	Houston Eye Associates	Houston	Texas
United States	Shettle Eye Research	Largo	Florida
United States	OCLI Vision	Manhasset	New York
United States	Total Eye Care, PA	Memphis	Tennessee
United States	VRF Eye Specialty Group	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	The Eye Centers of Racine and Kenosha	Racine	Wisconsin
United States	Vistar Eye Center	Roanoke	Virginia
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	Center For Sight	Venice	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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