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

Aerie Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Open-angle Glaucoma; Ocular Hypertension

Treatments: Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%; Drug: PG324 Ophthalmic Solution 0.02%/0.005%; Drug: Latanoprost Ophthalmic Solution 0.005%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02558400

PG324-CS301

Details and patient eligibility

About

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.

Enrollment: 718 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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718 participants in 3 patient groups

PG324 Ophthalmic Solution 0.02%/0.005%

Experimental group

Description:

Fixed combination of netarsudil 0.02%, latanoprost 0.005% ophthalmic solution

Treatment:

Drug: PG324 Ophthalmic Solution 0.02%/0.005%

AR-13324 Ophthalmic Solution 0.02%

Active Comparator group

Description:

Netarsudil 0.02% ophthalmic solution

Treatment:

Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%

Latanoprost Ophthalmic Solution 0.005%

Active Comparator group

Description:

Latanoprost 0.005% ophthalmic solution

Treatment:

Drug: Latanoprost Ophthalmic Solution 0.005%