Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle 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 daily in the evening (PM) in both eyes (OU); 1 drop daily in the evening (PM) in both eyes (OU); 1 drop daily 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: 750.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to
      netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older (19 years of age or older in Canada)

          2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension(OHT) in both eyes

          3. Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualification
             visits

          4. Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better

          5. Able to give informed consent and follow study instructions

        Exclusion Criteria:

        Ophthalmic:

          1. Clinically significant ocular disease

          2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure
             or narrow angles

          3. Unmedicated intraocular pressure ≥36mmHg in either eye or use of more than 2 ocular
             hypotensive medications within 30 days of screening

          4. Known hypersensitivity to any component of the formulation or latanoprost

          5. Previous glaucoma surgery or refractive surgery

          6. Ocular trauma within 6 months prior to screening

          7. Any ocular surgery or non-refractive laser treatment within 3 months prior to
             screening

          8. Recent or current ocular infection or inflammation in either eye

          9. Use of ocular medication in either eye of any kind within 30 days of screening and
             throughout of the study

         10. Mean central corneal thickness >620µm at screening in either eye

         11. Any abnormality preventing reliable applanation tonometry of either eye

             Systemic:

         12. Clinically significant abnormalities in lab tests at screening

         13. Clinically significant systemic disease

         14. Participation in any investigational study within 60 days prior to screening

         15. Systemic medication that could have had a substantial effect on IOP within 30 days
             prior to screening, or anticipated to be used during the study

         16. Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or
             not using a medically acceptable form of birth control