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

NCT ID: NCT03808688

Last Updated: 2020-09-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-27

Study Completion Date

2019-07-26

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma, Open-Angle Ocular Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Netarsudil Ophthalmic Solution 0.02%

Group Type OTHER

Netarsudil Ophthalmic Solution 0.02%

Intervention Type DRUG

1 drop in each eye once daily in the evening

Interventions

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Netarsudil Ophthalmic Solution 0.02%

1 drop in each eye once daily in the evening

Intervention Type DRUG

Other Intervention Names

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Rhopressa

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aerie Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Hollander, MD, MBA

Role: STUDY_DIRECTOR

Aerie Pharmaceuticals, Inc.

Locations

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Atlantis Eyecare

Huntington Beach, California, United States

Site Status

Harvard Eye Associates

Laguna Hills, California, United States

Site Status

North Bay Eye Associates, Inc

Petaluma, California, United States

Site Status

Shettle Eye Research Inc

Largo, Florida, United States

Site Status

Center For Sight

Sarasota, Florida, United States

Site Status

Coastal Research Associates, LLC

Roswell, Georgia, United States

Site Status

Wheaton Eye Clinic, Ltd

Wheaton, Illinois, United States

Site Status

Stiles Eyecare Excellence and Glaucoma Institute, PA

Overland Park, Kansas, United States

Site Status

Gaddie Eye Centers, LLC

Louisville, Kentucky, United States

Site Status

Glaucoma Consultants

Baltimore, Maryland, United States

Site Status

Tekwani Vision Center

St Louis, Missouri, United States

Site Status

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

Tulsa, Oklahoma, United States

Site Status

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, United States

Site Status

Valley Eye Professionals, LLC

Huntingdon Valley, Pennsylvania, United States

Site Status

Carolina Cataract & Laser Center

Ladson, South Carolina, United States

Site Status

Total Eye Care, PA

Memphis, Tennessee, United States

Site Status

VRF Eye Specialty Group

Memphis, Tennessee, United States

Site Status

Advancing Vision Research

Nashville, Tennessee, United States

Site Status

Keystone Research

Austin, Texas, United States

Site Status

Cataract & Glaucoma Center

El Paso, Texas, United States

Site Status

Houston Eye Associates

Houston, Texas, United States

Site Status

The Eye Centers of Racine and Kenosha

Racine, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33733980 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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MA-RHO-18-002

Identifier Type: -

Identifier Source: org_study_id

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