Study of Rhopressa® for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting

Ocular Hypertension Clinical Trial

Official title:

A Multicenter, Open-label Study of Rhopressa® (Netarsudil Ophthalmic Solution) 0.02% for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03808688
• Other study ID #: MA-RHO-18-002
• Status: Completed
• Phase: Phase 4
• Start date: December 27, 2018
• Est. completion date: July 26, 2019

Study information

• Verified date: November 2019
• Source: Aerie Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the IOP lowering efficacy of netarsudil ophthalmic solution 0.02% when used as monotherapy or when used concomitantly with other IOP-lowering agents in subjects with elevated IOP due to open angle glaucoma or ocular hypertension in a real-world clinical setting. The study is an open-label design. The patients will receive treatment for 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: July 26, 2019
• Est. primary completion date: July 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Male or female subjects (aged 18 or older)

2. Subjects diagnosed with open-angle glaucoma or ocular hypertension, and determined by the treating physician to require additional intraocular pressure (IOP)-lowering treatment with netarsudil 0.02%.

3. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing questionnaires and completing laboratory tests

Key Exclusion Criteria:

1. Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation

2. Women of childbearing potential who are pregnant, nursing, or planning a pregnancy and not using a medically acceptable form of birth control. Male subjects with a female partner of childbearing potential must have had a prior vasectomy or agree to use an effective method of birth control during the treatment period and for 3 months after the subject has completed the study.

3. Known sensitivity or allergy to the study medication or components

4. 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

5. Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Baseline Visit

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• Netarsudil Ophthalmic Solution 0.02%
1 drop in each eye once daily in the evening

Locations

Country	Name	City	State
United States	Keystone Research	Austin	Texas
United States	Glaucoma Consultants	Baltimore	Maryland
United States	Scott & Christie and Associates, PC	Cranberry Township	Pennsylvania
United States	Cataract & Glaucoma Center	El Paso	Texas
United States	Houston Eye Associates	Houston	Texas
United States	Valley Eye Professionals, LLC	Huntingdon Valley	Pennsylvania
United States	Atlantis Eyecare	Huntington Beach	California
United States	Carolina Cataract & Laser Center	Ladson	South Carolina
United States	Harvard Eye Associates	Laguna Hills	California
United States	Shettle Eye Research Inc	Largo	Florida
United States	Gaddie Eye Centers, LLC	Louisville	Kentucky
United States	Total Eye Care, PA	Memphis	Tennessee
United States	VRF Eye Specialty Group	Memphis	Tennessee
United States	Advancing Vision Research	Nashville	Tennessee
United States	Stiles Eyecare Excellence and Glaucoma Institute, PA	Overland Park	Kansas
United States	North Bay Eye Associates, Inc	Petaluma	California
United States	The Eye Centers of Racine and Kenosha	Racine	Wisconsin
United States	Coastal Research Associates, LLC	Roswell	Georgia
United States	Tekwani Vision Center	Saint Louis	Missouri
United States	Center For Sight	Sarasota	Florida
United States	Mark J. Weiss, M.D., Inc.	Tulsa	Oklahoma
United States	Wheaton Eye Clinic, Ltd	Wheaton	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure (IOP)	Percent Change from Baseline IOP at Week 12, as measured by Goldmann applanation tonometry.; Prostaglandin analog (PGA). Fixed dose combination (FDC).	12 weeks