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

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ClinicalTrials.gov Identifier: NCT02057575
Recruitment Status : Completed
First Posted : February 7, 2014
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Ocular Hypertension Drug: PG324 Ophthalmic Solution 0.01% Drug: PG324 Ophthalmic Solution 0.02% Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02% Drug: Latanoprost Ophthalmic Solution 0.005% Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 298 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-masked, Randomized, Controlled Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution, 0.01% and PG324 Ophthalmic Solution, 0.02%, Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Patients With Elevated Intraocular Pressure
Study Start Date : January 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: PG324 Ophthalmic Solution 0.01%
Netarsudil 0.01%, Latanoprost 0.005% fixed combination ophthalmic solution
 Drug: PG324 Ophthalmic Solution 0.01%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
Experimental: PG324 Ophthalmic Solution 0.02%
Netarsudil 0.02%, Latanoprost 0.005% fixed combination ophthalmic solution
 Drug: PG324 Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
Active Comparator: Netarsudil (AR-13324) Ophthalmic Solution 0.02%
Netarsudil 0.02% ophthalmic solution
 Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
Active Comparator: Latanoprost Ophthalmic Solution 0.005%
Latanoprost 0.005% ophthalmic solution
 Drug: Latanoprost Ophthalmic Solution 0.005%
1 drop in the evening (PM), once daily (QD), both eyes (OU)


Outcome Measures
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Primary Outcome Measures :
  1. Intraocular Pressure (IOP) [ Time Frame: Study treatment was administered for 28 days, and outcome measures collected on Day 29 ]
    The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or greater.
  • Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)
  • Corrected visual acuity in each eye equivalent to 20/200 or better
  • Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria:

Ophthalmic:

  • Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles.
  • Intraocular pressure >36 mmHg
  • Known hypersensitivity to any component of the formulation, latanoprost, or to topical anesthetics.
  • Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s)
  • Refractive surgery in study eye(s)
  • Ocular trauma within the six months prior to screening, or ocular surgery or laser treatment within the three months prior to screening.
  • Evidence of ocular infection and inflammation
  • Clinically significant ocular disease, which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe
  • Central corneal thickness greater then 600 μm
  • Any abnormality preventing reliable applanation tonometry of either eye

Systemic:

  • Clinically significant abnormalities (as determined by the investigator) in laboratory tests at screening.
  • Clinically significant systemic disease
  • Participation in any investigational study within 30 days prior to screening
  • Changes in systemic medication
  • Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057575


Locations
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Sponsors and Collaborators
Aerie Pharmaceuticals
Investigators
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Study Director: Nancy Ramirez, M.S. Aerie Pharmaceuticals, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02057575    
Other Study ID Numbers: PG324-CS201
First Posted: February 7, 2014    Key Record Dates
Results First Posted: June 4, 2019
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aerie Pharmaceuticals:
Open Angle Glaucoma
Ocular Hypertension
Intraocular Pressure
AR13324
PG324
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
 Eye Diseases
Latanoprost
Pharmaceutical Solutions
Ophthalmic Solutions
Antihypertensive Agents