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

Aerie Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Open-angle Glaucoma; Ocular Hypertension

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02674854

PG324-CS302

Details and patient eligibility

About

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%

Enrollment: 750 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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750 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%

Netarsudil (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%