Clinical trial NCT02558400: Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Official title: 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: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-angle Glaucoma
Ocular Hypertension
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-09-24
Enrollment: 718
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: 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)
Secondary outcomes:
measure: Extent of Exposure
timeFrame: 12 months
Other outcomes:
Locations:
city: Bedminster
country: United States
facility: Aerie Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Aerie Pharmaceuticals, Inc.
name: Theresa Heah, MD, MBA
role: STUDY_DIRECTOR
References:
citation: Asrani S, Bacharach J, Holland E, McKee H, Sheng H, Lewis RA, Kopczynski CC, Heah T. Fixed-Dose Combination of Netarsudil and Latanoprost in Ocular Hypertension and Open-Angle Glaucoma: Pooled Efficacy/Safety Analysis of Phase 3 MERCURY-1 and -2. Adv Ther. 2020 Apr;37(4):1620-1631. doi: 10.1007/s12325-020-01277-2. Epub 2020 Mar 12.