Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure

Conditions

• Ocular Hypertension
• Open Angle Glaucoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• PG324 Ophthalmic Solution 0.01% — DRUG
  1 drop in the evening (PM), once daily (QD), both eyes (OU)
• PG324 Ophthalmic Solution 0.02% — DRUG
  1 drop in the evening (PM), once daily (QD), both eyes (OU)
• Netarsudil (AR-13324) Ophthalmic Solution 0.02% — DRUG
  1 drop in the evening (PM), once daily (QD), both eyes (OU)
• Latanoprost Ophthalmic Solution 0.005% — DRUG
  1 drop in the evening (PM), once daily (QD), both eyes (OU)

Study Details

To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.

Key Dates

Start date

Jan 31, 2014

Status verified

May 2019

Primary completion

Jun 30, 2014

Completion

Jun 30, 2014

Study Design

Enrollment

298 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: PG324 Ophthalmic Solution 0.01%
  Netarsudil 0.01%, Latanoprost 0.005% fixed combination ophthalmic solution
• Experimental: PG324 Ophthalmic Solution 0.02%
  Netarsudil 0.02%, Latanoprost 0.005% fixed combination 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: Study treatment was administered for 28 days, and outcome measures collected on Day 29 ]

Locations (23)

Find similar trials in Artesia, CA

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