Overview

This trial is active, not recruiting.

Conditions open-angle glaucoma, ocular hypertension
Treatments netarsudil (ar-13324) ophthalmic solution, timolol maleate ophthalmic solution
Phase phase 3
Sponsor Aerie Pharmaceuticals
Start date September 2015
End date November 2016
Trial size 700 participants
Trial identifier NCT02558374, AR-13324-CS304

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
1 drop placebo daily (morning), both eyes 1 drop active (evening), both eyes
netarsudil (ar-13324) ophthalmic solution
1 drop placebo (morning) both eyes 1 drop active (evening) both eyes
(Active Comparator)
1 drop twice daily (morning/evening), both eyes
timolol maleate ophthalmic solution
1 drop twice daily (morning/evening) both eyes

Primary Outcomes

Measure
Mean intraocular pressure
time frame: 3 months

Secondary Outcomes

Measure
Number of participants with adverse events as a measure of safety and tolerability
time frame: 6 months
Changes in visual acuity from baseline
time frame: 6 months
Changes in visual field test from baseline
time frame: 6 months
Changes in pupil size from baseline
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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 2 qualification visits 4. Corrected visual acuity equivalent to 20/200 5. Able to give informed consent and follow study instructions Exclusion Criteria: 1. Clinically significant ocular disease 2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or 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 to screening 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 intraocular pressure within 30 days prior to screening 18. Women who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control

Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Aerie Pharmaceuticals.