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Completed

NCT Number: NCT02558400

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

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.

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Key information

Conditions

Open-angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aerie Pharmaceuticals

Bedminster, New Jersey, 07921, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • Diagnosis of open angle glaucoma or ocular hypertension in both eyes
  • Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualification visits. Both eyes had to qualify at all qualification visits
  • Corrected visual acuity equivalent to 20/200 Snellen or better
  • Able to give informed consent and follow study instructions

Exclusion criteria

  • Clinically significant ocular disease
  • Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
  • Unmedicated Intraocular pressure ≥36mmHg
  • Use of more than 2 ocular hypotensive medications within 30 days of screening
  • Known hypersensitivity to any component of the formulation
  • Previous glaucoma surgery or refractive surgery
  • Ocular trauma within 6 months prior to screening
  • Any ocular surgery or non-refractive laser treatment within 3 months prior to screening
  • Recent or current ocular infection or inflammation in either eye
  • Used ocular medication in either eye of any kind within 30 days of screening
  • Mean central corneal thickness >620µm at screening
  • Any abnormality preventing reliable applanation tonometry of either eye
  • Clinically significant abnormalities in lab tests at screening
  • Clinically significant systemic disease
  • Participation in any investigational study within 60 days prior to screening
  • Used any systemic medication that could have a substantial effect on intraocular pressure within 30 days prior to screening
  • Women who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control

Treatment and study plan

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)

Primary outcomes

  1. 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)

    The primary efficacy variable was mean IOP at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry. Secondary analysis were conducted as a part of safety measurements to month 12 on treatment.

Secondary outcomes

  1. Extent of Exposure

    Time frame: 12 months

    Exposure to study medication in days for all treatment groups

Sponsors and collaborators

Lead sponsor

Aerie Pharmaceuticals

Industry

Registry information

Official study title

A Prospective, Double-masked, Randomized, Multi-center, Active-controlled, Parallel-group 12-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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 24, 2015
Registry last updated
Jun 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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