Rocklatan® Evaluation

Sponsor
Aerie Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05283395
Collaborator
(none)
180
14
1
14.1
12.9
0.9

Study Details

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 individual agents/bottles with another mechanism of action.

Condition or Disease Intervention/Treatment Phase
  • Drug: Rocklatan® (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Enrollment will be stratified based on subject's current Baseline Intraocular Pressure (IOP) lowering therapy regimen.Enrollment will be stratified based on subject's current Baseline Intraocular Pressure (IOP) lowering therapy regimen.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 28, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%

Drug: Rocklatan® (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
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

Outcome Measures

Primary Outcome Measures

  1. Intraocular Pressure (IOP) [Week 12]

    Percentage change of IOP from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 North Valley Eye Medical Group Mission Hills California United States 91345
2 Visionary Eye Institute Newport Beach California United States 92663
3 North Bay Eye Associates Petaluma California United States 94954
4 Center For Sight Venice Florida United States 34285
5 Georgia Eye Partners Atlanta Georgia United States 30342
6 Coastal Research Associates LLC Roswell Georgia United States 30076
7 Tekwani Vision Center Saint Louis Missouri United States 63128
8 Mark J. Weiss, MD, Inc. Tulsa Oklahoma United States 74104
9 Scott & Christie and Associates, PC Cranberry Township Pennsylvania United States 16066
10 Total Eye Care, PA Memphis Tennessee United States 38199
11 Keystone Research Austin Texas United States 78731
12 Louis M. Alpern, M.D., M.P.H., P.A El Paso Texas United States 79902
13 Houston Eye Associates Houston Texas United States 77025
14 The Eye Centers of Racine and Kenosha Racine Wisconsin United States 53405

Sponsors and Collaborators

  • Aerie Pharmaceuticals

Investigators

  • Study Director: Michelle S Senchyna, PhD, Aerie Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT05283395
Other Study ID Numbers:
  • MA-ROC-22-003
First Posted:
Mar 17, 2022
Last Update Posted:
Aug 15, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2022