Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Overview

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.

Full Title of Study: “A Prospective, Double-masked, Randomized, Multi-center, Active-controlled, Parallel-group 12-month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Subjects With Elevated Intraocular Pressure”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 17, 2017

Interventions

  • Drug: PG324 Ophthalmic Solution 0.02%/0.005%
    • 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
  • Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%
    • 1 drop once daily (QD), in the evening (PM) in both eyes (OU)
  • Drug: Latanoprost Ophthalmic Solution 0.005%
    • 1 drop once daily (QD), in the evening (PM) in both eyes (OU)

Arms, Groups and Cohorts

  • Experimental: PG324 Ophthalmic Solution 0.02%/0.005%
    • Fixed combination of netarsudil 0.02%, latanoprost 0.005% ophthalmic solution
  • Active Comparator: AR-13324 Ophthalmic Solution 0.02%
    • Netarsudil 0.02% ophthalmic solution
  • Active Comparator: Latanoprost Ophthalmic Solution 0.005%
    • Latanoprost 0.005% ophthalmic solution

Clinical Trial Outcome Measures

Primary Measures

  • Intraocular Pressure (IOP)
    • Time Frame: Primary efficacy endpoint measured for 3 months (data collected at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90)
    • The primary efficacy variable was mean IOP at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry. Secondary analysis were conducted as a part of safety measurements to month 12 on treatment.

Secondary Measures

  • Extent of Exposure
    • Time Frame: 12 months
    • Exposure to study medication in days for all treatment groups

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aerie Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Theresa Heah, MD, MBA, Study Director, Aerie Pharmaceuticals, Inc.

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