Clinical trial NCT03808688: Study of Rhopressa® for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-01-17
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Atlantis Eyecare
state: California
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates, Inc
state: California
city: Largo
country: United States
facility: Shettle Eye Research Inc
state: Florida
city: Sarasota
country: United States
facility: Center For Sight
state: Florida
city: Roswell
country: United States
facility: Coastal Research Associates, LLC
state: Georgia
city: Wheaton
country: United States
facility: Wheaton Eye Clinic, Ltd
state: Illinois
city: Overland Park
country: United States
facility: Stiles Eyecare Excellence and Glaucoma Institute, PA
state: Kansas
city: Louisville
country: United States
facility: Gaddie Eye Centers, LLC
state: Kentucky
city: Baltimore
country: United States
facility: Glaucoma Consultants
state: Maryland
city: Saint Louis
country: United States
facility: Tekwani Vision Center
state: Missouri
city: Tulsa
country: United States
facility: Mark J. Weiss, M.D., Inc.
state: Oklahoma
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Huntingdon Valley
country: United States
facility: Valley Eye Professionals, LLC
state: Pennsylvania
city: Ladson
country: United States
facility: Carolina Cataract & Laser Center
state: South Carolina
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Memphis
country: United States
facility: VRF Eye Specialty Group
state: Tennessee
city: Nashville
country: United States
facility: Advancing Vision Research
state: Tennessee
city: Austin
country: United States
facility: Keystone Research
state: Texas
city: El Paso
country: United States
facility: Cataract & Glaucoma Center
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Racine
country: United States
facility: The Eye Centers of Racine and Kenosha
state: Wisconsin
Study officials:
affiliation: Aerie Pharmaceuticals, Inc.
name: David Hollander, MD, MBA
role: STUDY_DIRECTOR
References:
citation: 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.