Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
136 participants
INTERVENTIONAL
2022-03-28
2023-03-22
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rocklatan
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Aerie Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Scientific Advisor, Clinical R&D
Role: STUDY_DIRECTOR
Alcon Research, LLC
Locations
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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
Shettle Eye Research
Largo, Florida, United States
Center For Sight
Venice, Florida, United States
Georgia Eye Partners
Atlanta, Georgia, United States
Coastal Research Associates LLC
Roswell, Georgia, United States
Tekwani Vision Center
St Louis, Missouri, United States
OCLI Vision
Manhasset, New York, United States
Mark J. Weiss, MD, Inc.
Tulsa, Oklahoma, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States
Advancing Vision Research
Goodlettsville, Tennessee, United States
VRF Eye Specialty Group
Memphis, Tennessee, United States
Total Eye Care, PA
Memphis, Tennessee, United States
Keystone Research
Austin, Texas, United States
Louis M. Alpern, M.D., M.P.H., P.A
El Paso, Texas, United States
Houston Eye Associates
Houston, Texas, United States
Emerson Clinical Research Institute
Falls Church, Virginia, United States
Vistar Eye Center
Roanoke, Virginia, United States
The Eye Centers of Racine and Kenosha
Racine, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MA-ROC-22-003
Identifier Type: -
Identifier Source: org_study_id
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