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

NCT03808688 | Completed Phase 4 Results FDA Drug

• 1 other identifier: MA-RHO-18-002
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 22

Brief 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.

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Netarsudil Ophthalmic Solution 0.02%

OTHER

Drug: Netarsudil Ophthalmic Solution 0.02%

Interventions

Netarsudil Ophthalmic Solution 0.02% DRUG

1 drop in each eye once daily in the evening

Also known as: Rhopressa

Netarsudil Ophthalmic Solution 0.02%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects (aged 18 or older)
• 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%.
• Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing questionnaires and completing laboratory tests

You may not qualify if:

• Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation
• 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.
• Known sensitivity or allergy to the study medication or components
• 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
• Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Baseline Visit

Sponsors & Collaborators

• Aerie Pharmaceuticals: lead

Study Sites (22)

Atlantis Eyecare

Huntington Beach, California, 92647, United States

Location

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

North Bay Eye Associates, Inc

Petaluma, California, 94954, United States

Location

Shettle Eye Research Inc

Largo, Florida, 33773, United States

Location

Center For Sight

Sarasota, Florida, 34238, United States

Location

Coastal Research Associates, LLC

Roswell, Georgia, 30076, United States

Location

Wheaton Eye Clinic, Ltd

Wheaton, Illinois, 60187, United States

Location

Stiles Eyecare Excellence and Glaucoma Institute, PA

Overland Park, Kansas, 66213, United States

Location

Gaddie Eye Centers, LLC

Louisville, Kentucky, 40241, United States

Location

Glaucoma Consultants

Baltimore, Maryland, 21204, United States

Location

Tekwani Vision Center

St Louis, Missouri, 63128, United States

Location

Mark J. Weiss, M.D., Inc.

Tulsa, Oklahoma, 74104, United States

Location

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, 16066, United States

Location

Valley Eye Professionals, LLC

Huntingdon Valley, Pennsylvania, 19006, United States

Location

Carolina Cataract & Laser Center

Ladson, South Carolina, 29456, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

VRF Eye Specialty Group

Memphis, Tennessee, 38120, United States

Location

Advancing Vision Research

Nashville, Tennessee, 37204, United States

Location

Keystone Research

Austin, Texas, 78731, United States

Location

Cataract & Glaucoma Center

El Paso, Texas, 79902, United States

Location

Houston Eye Associates

Houston, Texas, 77025, United States

Location

The Eye Centers of Racine and Kenosha

Racine, Wisconsin, 53405, United States

Location

Related Publications (1)

• Zaman F, Gieser SC, Schwartz GF, Swan C, Williams JM. A multicenter, open-label study of netarsudil for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension in a real-world setting. Curr Med Res Opin. 2021 Jun;37(6):1011-1020. doi: 10.1080/03007995.2021.1901222. Epub 2021 Mar 27.

  PMID: 33733980 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Results Point of Contact

• Title: VP, Medical Affairs
• Organization: Aerie Pharmaceuticals

jmwilliams@aeriepharma.com

949-246-8731

Study Officials

• David Hollander, MD, MBA

  Aerie Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: January 10, 2019
• First Posted: January 17, 2019
• Study Start: December 27, 2018
• Primary Completion: July 26, 2019
• Study Completion: July 26, 2019
• Last Updated: September 29, 2020
• Results First Posted: September 29, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (22)