Clinical trial NCT05283395: Rocklatan® Evaluation
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: Glaucoma
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-03-17
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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 (Latanoprost +1)
* Latanoprost plus 2 additional IOP-lowering agents (Latanoprost +2)

Aerie Pharmaceuticals was acquired by Alcon Research LLC on November 22, 2022.

Eligibility 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

Primary outcomes:
measure: Mean Percent Change From Baseline in Intraocular Pressure (IOP) at Week 12
timeFrame: Baseline (Day 0 pretreatment), Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Mission Hills
country: United States
facility: North Valley Eye Medical Group
state: California
city: Newport Beach
country: United States
facility: Visionary Eye Institute
state: California
city: Pasadena
country: United States
facility: California Eye Specialists Medical Group
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: Largo
country: United States
facility: Shettle Eye Research
state: Florida
city: Venice
country: United States
facility: Center For Sight
state: Florida
city: Atlanta
country: United States
facility: Georgia Eye Partners
state: Georgia
city: Roswell
country: United States
facility: Coastal Research Associates LLC
state: Georgia
city: Saint Louis
country: United States
facility: Tekwani Vision Center
state: Missouri
city: Manhasset
country: United States
facility: OCLI Vision
state: New York
city: Tulsa
country: United States
facility: Mark J. Weiss, MD, Inc.
state: Oklahoma
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Goodlettsville
country: United States
facility: Advancing Vision Research
state: Tennessee
city: Memphis
country: United States
facility: VRF Eye Specialty Group
state: Tennessee
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Austin
country: United States
facility: Keystone Research
state: Texas
city: El Paso
country: United States
facility: Louis M. Alpern, M.D., M.P.H., P.A
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Falls Church
country: United States
facility: Emerson Clinical Research Institute
state: Virginia
city: Roanoke
country: United States
facility: Vistar Eye Center
state: Virginia
city: Racine
country: United States
facility: The Eye Centers of Racine and Kenosha
state: Wisconsin
Study officials:
affiliation: Alcon Research, LLC
name: Scientific Advisor, Clinical R&D
role: STUDY_DIRECTOR
References: