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Completed

NCT Number: NCT05283395

Rocklatan® Evaluation

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

North Valley Eye Medical Group, Mission Hills, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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®

Primary outcomes

  1. Mean Percent Change From Baseline in Intraocular Pressure (IOP) at Week 12

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aerie Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 17, 2022
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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