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

Part of paid clinical trials in Bedminster, New Jersey.

Sponsor
Aerie Pharmaceuticals
Study ID
NCT02558400
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Key Dates

Start date
Sep 18, 2015
Status verified
May 2019
Primary completion
May 17, 2017
Completion
Jun 30, 2017

Study Design

Enrollment
718 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: 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: 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) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Aerie PharmaceuticalsBedminsterNew Jersey07921-

Find similar trials in Bedminster, NJ

By condition
Glaucoma
By specialty
Ophthalmology
By research site
Aerie Pharmaceuticals· Bedminster, NJ

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