Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension

Sponsor
Aerie Pharmaceuticals
Study ID
NCT03284853
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Netarsudil/Latanoprost 0.02%/0.005% — DRUG
    Topical sterile ophthalmic solution
  • GANFORT® — DRUG
    Topical sterile ophthalmic solution

Study Details

The study is intended to test the effectiveness and safety of Netarsudil / Latanoprost 0.02% / 0.005% Ophthalmic Solution, relative to GANFORT® for lowering of intraocular pressure (IOP) in patients with elevated intraocular pressure

Key Dates

Start date
Sep 5, 2017
Status verified
Jan 2022
Primary completion
Nov 6, 2020
Completion
Nov 6, 2020

Study Design

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

Arms

  • Experimental: Netarsudil/Latanoprost 0.02%/0.005%
    PG324 Ophthalmic Solution (netarsudil 0.02% / latanoprost 0.005%) one drop daily to each eye for 180 days.
  • Active Comparator: GANFORT®
    GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic solution one drop daily to each eye for 180 days.

Primary Outcome Measure

Mean Diurnal Intraocular Pressure by Goldmann Applanation Tonometry [ Time Frame: Day 90 ]

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