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Rocklatan® Evaluation

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rocklatan® (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
Sponsored by
Aerie Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North Valley Eye Medical Group
  • Visionary Eye Institute
  • California Eye Specialists Medical Group
  • North Bay Eye Associates
  • Shettle Eye Research
  • Center For Sight
  • Georgia Eye Partners
  • Coastal Research Associates LLC
  • Tekwani Vision Center
  • OCLI Vision
  • Mark J. Weiss, MD, Inc.
  • Scott & Christie and Associates, PC
  • Advancing Vision Research
  • VRF Eye Specialty Group
  • Total Eye Care, PA
  • Keystone Research
  • Louis M. Alpern, M.D., M.P.H., P.A
  • Houston Eye Associates
  • Emerson Clinical Research Institute
  • Vistar Eye Center
  • The Eye Centers of Racine and Kenosha

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%

Arm Description

Outcomes

Primary Outcome Measures

Intraocular Pressure (IOP)
Percentage change of IOP from baseline

Secondary Outcome Measures

Full Information

First Posted
March 7, 2022
Last Updated
April 19, 2023
Sponsor
Aerie Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05283395
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
March 22, 2023 (Actual)
Study Completion Date
March 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerie Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to evaluate whether the IOP lowering with Rocklatan® is similar, or demonstrates additional IOP lowering, in subjects on a current regimen of latanoprost alone or latanoprost plus addition of either one or two IOP-lowering agents with another mechanism of action.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Enrollment will be stratified based on subject's current Baseline Intraocular Pressure (IOP) lowering therapy regimen.
Masking
None (Open Label)
Allocation
N/A
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Rocklatan® (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
Intervention Description
Enrolled subjects will be instructed to self-instill 1 drop of Rocklatan® (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% in each eye daily in the evening
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Description
Percentage change of IOP from baseline
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle S Senchyna, PhD
Organizational Affiliation
Aerie Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
North Valley Eye Medical Group
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Visionary Eye Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
California Eye Specialists Medical Group
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
North Bay Eye Associates
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Shettle Eye Research
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
Center For Sight
City
Venice
State/Province
Florida
ZIP/Postal Code
34285
Country
United States
Facility Name
Georgia Eye Partners
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Coastal Research Associates LLC
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Tekwani Vision Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
OCLI Vision
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Mark J. Weiss, MD, Inc.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Scott & Christie and Associates, PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Advancing Vision Research
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
VRF Eye Specialty Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Total Eye Care, PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38199
Country
United States
Facility Name
Keystone Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Louis M. Alpern, M.D., M.P.H., P.A
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Emerson Clinical Research Institute
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22046
Country
United States
Facility Name
Vistar Eye Center
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Facility Name
The Eye Centers of Racine and Kenosha
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Rocklatan® Evaluation

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