Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Completed · Phase 3
Conditions studied: Open-angle Glaucoma, Ocular Hypertension
In brief
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.
Key facts
- Study ID
- NCT02558400
- Run by
- Aerie Pharmaceuticals
- People needed
- 718
- Starts
- 2015-09-18
- Expected to finish
- 2017-06-30
- Last updated by the study team
- 2019-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years of age or older
- Diagnosis of open angle glaucoma or ocular hypertension in both eyes
- Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualification visits. Both eyes had to qualify at all qualification visits
- Corrected visual acuity equivalent to 20/200 Snellen or better
- Able to give informed consent and follow study instructions
You may not qualify if…
- Clinically significant ocular disease
- Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
- Unmedicated Intraocular pressure ≥36mmHg
- Use of more than 2 ocular hypotensive medications within 30 days of screening
- Known hypersensitivity to any component of the formulation
- Previous glaucoma surgery or refractive surgery
- Ocular trauma within 6 months prior to screening
- Any ocular surgery or non-refractive laser treatment within 3 months prior to screening
- Recent or current ocular infection or inflammation in either eye
- Used ocular medication in either eye of any kind within 30 days of screening
- Mean central corneal thickness >620µm at screening
- Any abnormality preventing reliable applanation tonometry of either eye
- Clinically significant abnormalities in lab tests at screening
- Clinically significant systemic disease
- Participation in any investigational study within 60 days prior to screening
- Used any systemic medication that could have a substantial effect on intraocular pressure within 30 days prior to screening
- Women who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control
Where it is running
- Aerie Pharmaceuticals — Bedminster, New Jersey, United States
Full record on ClinicalTrials.gov
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