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

Part of paid clinical trials in Bedminster, New Jersey.

Sponsor
Aerie Pharmaceuticals
Study ID
NCT02674854
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • PG324 Ophthalmic Solution 0.02%/0.005% — DRUG
    1 drop daily in the evening (PM) in both eyes (OU)
  • Netarsudil (AR-13324) ophthalmic solution 0.02% — DRUG
    1 drop daily in the evening (PM) in both eyes (OU)
  • Latanoprost ophthalmic solution 0.005% — DRUG
    1 drop daily in the evening (PM) in both eyes (OU)

Study Details

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%

Key Dates

Start date
Feb 29, 2016
Status verified
May 2019
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017

Study Design

Enrollment
750 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Intraocular Pressure (IOP) [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Aerie PharmaceuticalsBedminsterNew Jersey07921-

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