Clinical trial NCT02674854: Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension
Official title: A Prospective, Double-masked, Randomized, Multi-center, Active Controlled, Parallel-group, 3-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: 2016-02-05
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
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 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

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: 3 months
Secondary outcomes:
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: Walter TR, Ahmed IK et al. Ophthalmology glaucoma, 2019, pg. 1-10 https://doi.org/10.1016/j.ogla.2019.03.007
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.
citation: Wisely CE, Sheng H, Heah T, Kim T. Effects of Netarsudil and Latanoprost Alone and in Fixed Combination on Corneal Endothelium and Corneal Thickness: Post-Hoc Analysis of MERCURY-2. Adv Ther. 2020 Mar;37(3):1114-1123. doi: 10.1007/s12325-020-01227-y. Epub 2020 Jan 24.