Rocklatan® Evaluation

Aerie Pharmaceuticals

Status and phase

Completed

Phase 4

Conditions

Glaucoma

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT05283395

MA-ROC-22-003

Details and patient eligibility

About

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).

Full 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.

Enrollment

136 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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