Status:

COMPLETED

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

Lead Sponsor:

Aerie Pharmaceuticals

Conditions:

Glaucoma, Open-Angle

Ocular Hypertension

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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 op...

Eligibility Criteria

Inclusion

  • Key
  • 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
  • Key

Exclusion

  • 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

Key Trial Info

Start Date :

December 27 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 26 2019

Estimated Enrollment :

261 Patients enrolled

Trial Details

Trial ID

NCT03808688

Start Date

December 27 2018

End Date

July 26 2019

Last Update

September 29 2020

Active Locations (22)

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Page 1 of 6 (22 locations)

1

Atlantis Eyecare

Huntington Beach, California, United States, 92647

2

Harvard Eye Associates

Laguna Hills, California, United States, 92653

3

North Bay Eye Associates, Inc

Petaluma, California, United States, 94954

4

Shettle Eye Research Inc

Largo, Florida, United States, 33773