Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Condition: Open-angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: PG324 Ophthalmic Solution 0.02%/0.005%; Netarsudil (AR-13324) Ophthalmic Solution 0.02%; Latanoprost Ophthalmic Solution 0.005%
Intervention description: 1 drop once daily (QD), in the evening (PM) in both eyes (OU); 1 drop once daily (QD), in the evening (PM) in both eyes (OU); 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
Intervention MeSH terms: Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 718.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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 both eyes at 2 qualification
             visits. Both eyes had to qualify at all qualification visits

          4. Corrected visual acuity equivalent to 20/200 Snellen or better

          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