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Double-masked Study of PG324 Ophthalmic Solution in Patients With 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: NCT02558400
Recruitment Status : Completed
First Posted : September 24, 2015
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Brief Summary:

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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 718 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 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
Actual Study Start Date : September 18, 2015
Actual Primary Completion Date : May 17, 2017
Actual Study Completion Date : June 30, 2017


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 once daily (QD), in the evening (PM) in both eyes (OU)

Active Comparator: AR-13324 Ophthalmic Solution 0.02%
Netarsudil 0.02% ophthalmic solution
Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%
1 drop once daily (QD), 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 once daily (QD), in the evening (PM) in both eyes (OU)




Primary Outcome Measures :
  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 Outcome Measures :
  1. Extent of Exposure [ Time Frame: 12 months ]
    Exposure to study medication in days for all treatment groups



Information from the National Library of Medicine

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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:

  1. 18 years of age or older
  2. Diagnosis of open angle glaucoma or ocular hypertension in both eyes
  3. Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualification visits. Both eyes had to qualify at all qualification visits
  4. Corrected visual acuity equivalent to 20/200 Snellen or better
  5. Able to give informed consent and follow study instructions

Exclusion Criteria:

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

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): NCT02558400


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] June 12, 2017
Statistical Analysis Plan  [PDF] July 20, 2016


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Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02558400     History of Changes
Other Study ID Numbers: PG324-CS301
First Posted: September 24, 2015    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

Additional relevant MeSH terms:
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Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Latanoprost
Antihypertensive Agents