Status:
COMPLETED
Rocklatan® Evaluation
Lead Sponsor:
Aerie Pharmaceuticals
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 therap...
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 (...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2023
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT05283395
Start Date
March 28 2022
End Date
March 22 2023
Last Update
April 3 2024
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
North Valley Eye Medical Group
Mission Hills, California, United States, 91345
2
Visionary Eye Institute
Newport Beach, California, United States, 92663
3
California Eye Specialists Medical Group
Pasadena, California, United States, 91107
4
North Bay Eye Associates
Petaluma, California, United States, 94954