Study of Rhopressa® for the Reduction of Elevated Intraocular Pressure in Patients With Glaucoma or Ocular Hypertension in a Real-world Setting
Status: | Recruiting |
---|---|
Conditions: | High Blood Pressure (Hypertension), Ocular |
Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/24/2019 |
Start Date: | December 27, 2018 |
End Date: | September 2019 |
Contact: | Julia Williams |
Email: | jmwilliams@aeriepharma.com |
Phone: | 949-526-8731 |
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
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.
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.
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
We found this trial at
17
sites
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