Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension

Last updated: March 9, 2018
Sponsor: Aerie Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Stress

Ocular Hypertension

Glaucoma

Treatment

N/A

Clinical Study ID

NCT02558374
AR-13324-CS304
  • Ages > 18
  • All Genders

Study Summary

To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 18 years of age or older

  2. Diagnosis of open angle glaucoma or ocular hypertension in both eyes

  3. Post-washout intraocular pressure >20mmHg and <30mmHg in 1 or both eyes at 2qualification visits

  4. Corrected visual acuity equivalent to 20/200

  5. Able to give informed consent and follow study instructions

Exclusion

Exclusion Criteria:

  1. Clinically significant ocular disease

  2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closureor narrow angles

  3. Unmedicated intraocular pressure ≥30mmHg

  4. Use of more than 2 ocular hypotensive medications within 30 days of screening

  5. Known hypersensitivity to any component of the formulation

  6. Previous glaucoma surgery or refractive surgery

  7. Ocular trauma within 6 months prior to screening

  8. Any ocular surgery or non-refractive laser treatment within 3 months prior toscreening

  9. Recent or current ocular infection or inflammation in either eye

  10. Used ocular medication in either eye of any kind within 30 days of screening

  11. Mean central corneal thickness >620µm at screening

  12. Any abnormality preventing reliable applanation tonometry of either eye

  13. Clinically significant abnormalities in lab tests at screening

  14. Known hypersensitivity or contraindication to beta-adrenoceptor antagonists

  15. Clinically significant systemic disease

  16. Participation in any investigational study within 60 days prior to screening

  17. Used any systemic medication that could have a substantial effect in intraocularpressure within 30 days prior to screening

  18. Women who are pregnant, nursing, planning a pregnancy or not using a medicallyacceptable form of birth control

Study Design

Total Participants: 708
Study Start date:
September 01, 2015
Estimated Completion Date:
December 31, 2016

Connect with a study center

  • Aerie Pharmaceuticals

    Bedminster, New Jersey 07921
    United States

    Site Not Available

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