Rocklatan® Evaluation
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
1 other identifier
interventional
136
1 country
21
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 therapy regimen and dose with Rocklatan for the duration of the study (12 weeks).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2022
Shorter than P25 for phase_4
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2022
CompletedFirst Posted
Study publicly available on registry
March 17, 2022
CompletedStudy Start
First participant enrolled
March 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2023
CompletedResults Posted
Study results publicly available
April 3, 2024
CompletedApril 3, 2024
January 1, 2024
12 months
March 7, 2022
March 8, 2024
March 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Rocklatan
EXPERIMENTALNetarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, one drop in each eye in the evening for 12 weeks
Interventions
Commercially available ophthalmic solution indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
North Valley Eye Medical Group
Mission Hills, California, 91345, United States
Visionary Eye Institute
Newport Beach, California, 92663, United States
California Eye Specialists Medical Group
Pasadena, California, 91107, United States
North Bay Eye Associates
Petaluma, California, 94954, United States
Shettle Eye Research
Largo, Florida, 33773, United States
Center For Sight
Venice, Florida, 34285, United States
Georgia Eye Partners
Atlanta, Georgia, 30342, United States
Coastal Research Associates LLC
Roswell, Georgia, 30076, United States
Tekwani Vision Center
St Louis, Missouri, 63128, United States
OCLI Vision
Manhasset, New York, 11030, United States
Mark J. Weiss, MD, Inc.
Tulsa, Oklahoma, 74104, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066, United States
Advancing Vision Research
Goodlettsville, Tennessee, 37072, United States
VRF Eye Specialty Group
Memphis, Tennessee, 38120, United States
Total Eye Care, PA
Memphis, Tennessee, 38199, United States
Keystone Research
Austin, Texas, 78731, United States
Louis M. Alpern, M.D., M.P.H., P.A
El Paso, Texas, 79902, United States
Houston Eye Associates
Houston, Texas, 77025, United States
Emerson Clinical Research Institute
Falls Church, Virginia, 22046, United States
Vistar Eye Center
Roanoke, Virginia, 24016, United States
The Eye Centers of Racine and Kenosha
Racine, Wisconsin, 53405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Scientific Advisor, Clinical R&D
- Organization
- Alcon Research, LLC
Study Officials
- STUDY DIRECTOR
Scientific Advisor, Clinical R&D
Alcon Research, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2022
First Posted
March 17, 2022
Study Start
March 28, 2022
Primary Completion
March 22, 2023
Study Completion
March 22, 2023
Last Updated
April 3, 2024
Results First Posted
April 3, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share