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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02674854
Recruitment Status : Completed
First Posted : February 5, 2016
Results First Posted : May 1, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Study Description
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Brief Summary:
To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%

Condition or disease Intervention/treatment Phase
Open-angle Glaucoma Ocular Hypertension Drug: PG324 Ophthalmic Solution 0.02%/0.005% Drug: Netarsudil (AR-13324) ophthalmic solution 0.02% Drug: Latanoprost ophthalmic solution 0.005% Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Double-masked, Randomized, Multi-center, Active Controlled, Parallel-group, 3-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
Study Start Date : February 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

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 0.02%/0.005%
Fixed combination of netarsudil 0.02%, latanoprost 0.005 % ophthalmic solution
 Drug: PG324 Ophthalmic Solution 0.02%/0.005%
1 drop daily in the evening (PM) in 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 daily in the evening (PM) in both eyes (OU)
Active Comparator: Latanoprost ophthalmic solution 0.005%
Latanoprost 0.005 % ophthalmic solution
 Drug: Latanoprost ophthalmic solution 0.005%
1 drop daily in the evening (PM) in both eyes (OU)


Outcome Measures
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Primary Outcome Measures :
  1. Intraocular Pressure (IOP) [ Time Frame: 3 months ]
    Mean intraocular pressure(IOP) at 08:00, 10:00 and 16:00 hours, at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older (19 years of age or older in Canada)
  2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension(OHT) in both eyes
  3. Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualification visits
  4. Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better
  5. Able to give informed consent and follow study instructions

Exclusion Criteria:

Ophthalmic:

  1. Clinically significant ocular disease
  2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
  3. Unmedicated intraocular pressure ≥36mmHg in either eye or use of more than 2 ocular hypotensive medications within 30 days of screening
  4. Known hypersensitivity to any component of the formulation or latanoprost
  5. Previous glaucoma surgery or refractive surgery
  6. Ocular trauma within 6 months prior to screening
  7. Any ocular surgery or non-refractive laser treatment within 3 months prior to screening
  8. Recent or current ocular infection or inflammation in either eye
  9. Use of ocular medication in either eye of any kind within 30 days of screening and throughout of the study
  10. Mean central corneal thickness >620µm at screening in either eye

  11. Any abnormality preventing reliable applanation tonometry of either eye

    Systemic:

  12. Clinically significant abnormalities in lab tests at screening
  13. Clinically significant systemic disease
  14. Participation in any investigational study within 60 days prior to screening
  15. Systemic medication that could have had a substantial effect on IOP within 30 days prior to screening, or anticipated to be used during the study
  16. Women of childbearing potential who were 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): NCT02674854


Locations
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United States, New Jersey
Aerie Pharmaceuticals
Bedminster, New Jersey, United States, 07921
Sponsors and Collaborators
Aerie Pharmaceuticals
Investigators
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Study Director: Theresa Heah, MD, MBA Aerie Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by Aerie Pharmaceuticals:
Study Protocol  [PDF] April 8, 2016
Statistical Analysis Plan  [PDF] January 30, 2017

More Information
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Publications of Results:
Walter TR, Ahmed IK et al. Ophthalmology glaucoma, 2019, pg. 1-10 https://doi.org/10.1016/j.ogla.2019.03.007

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02674854    
Other Study ID Numbers: PG324-CS302
First Posted: February 5, 2016    Key Record Dates
Results First Posted: May 1, 2019
Last Update Posted: May 21, 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
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Latanoprost
Ophthalmic Solutions