This trial is active, not recruiting.

Conditions open-angle glaucoma, ocular hypertension
Treatments pg324 ophthalmic solution, netarsudil (ar-13324) ophthalmic solution, latanoprost ophthalmic solution
Phase phase 3
Sponsor Aerie Pharmaceuticals
Start date September 2015
End date June 2017
Trial size 690 participants
Trial identifier NCT02558400, PG324-CS301


To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to Netarsudil (AR-13324) Ophthalmic Solution and Latanoprost Ophthalmic Solution.

Following completion of the Month 12 study visit procedures, subjects will be offered the opportunity to participate in a 2-month observational (i.e., non-interventional) trial extension.

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
1 drop daily (evening) both eyes
pg324 ophthalmic solution
1 drop daily (evening) both eyes
(Active Comparator)
1 drop daily (evening) both eyes
netarsudil (ar-13324) ophthalmic solution
1 drop daily (evening) both eyes
(Active Comparator)
1 drop daily (evening) both eyes
latanoprost ophthalmic solution
1 drop daily (evening) both eyes

Primary Outcomes

Intraocular pressure
time frame: 3 months

Secondary Outcomes

Number of participants with adverse events as a measure of safety and tolerability
time frame: 12 months
Changes in visual acuity from baseline
time frame: 12 months
Changes in visual field test from baseline
time frame: 12 months
Changes in pupil size from baseline
time frame: 12 months

Eligibility Criteria

All 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. Unmedicated intraocular pressure >20mmHg and <36mmHg in 1 or both eyes at 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 ≥36mmHg 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. Clinically significant systemic disease 15. Participation in any investigational study within 60 days prior to screening 16. Used any systemic medication that could have a substantial effect on intraocular pressure within 30 days prior to screening 17. 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 January 2017.
Information provided to ClinicalTrials.gov by Aerie Pharmaceuticals.