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Trial record 1 of 1 for:    PG324-CS302
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Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension

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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

Tracking Information
First Submitted Date  ICMJE February 1, 2016
First Posted Date  ICMJE February 5, 2016
Results First Submitted Date  ICMJE April 11, 2019
Results First Posted Date  ICMJE May 1, 2019
Last Update Posted Date May 21, 2019
Study Start Date  ICMJE February 2016
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
Intraocular pressure [ Time Frame: 3 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 3 months ]
  • Changes in visual acuity from baseline (subject does better or worse reading lines on eye chart) [ Time Frame: Day 1, Day 15, Day 43, Day 90 ]
  • Changes in visual field from baseline determined as automated threshold perimetry [ Time Frame: Day 1, Day 90 ]
  • Changes in undilated pupil size in ambient light (measured with a ruler) from baseline [ Time Frame: Day 1, Day 90 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension
Official Title  ICMJE 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
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%
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Open-angle Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: PG324 Ophthalmic Solution 0.02%/0.005%
    1 drop daily in the evening (PM) in both eyes (OU)
  • Drug: Netarsudil (AR-13324) ophthalmic solution 0.02%
    1 drop daily in the evening (PM) in both eyes (OU)
  • Drug: Latanoprost ophthalmic solution 0.005%
    1 drop daily in the evening (PM) in both eyes (OU)
Study Arms  ICMJE
  • Experimental: PG324 Ophthalmic Solution 0.02%/0.005%
    Fixed combination of netarsudil 0.02%, latanoprost 0.005 % ophthalmic solution
    Intervention: Drug: PG324 Ophthalmic Solution 0.02%/0.005%
  • Active Comparator: Netarsudil (AR-13324) ophthalmic solution 0.02%
    Netarsudil 0.02% ophthalmic solution
    Intervention: Drug: Netarsudil (AR-13324) ophthalmic solution 0.02%
  • Active Comparator: Latanoprost ophthalmic solution 0.005%
    Latanoprost 0.005 % ophthalmic solution
    Intervention: Drug: Latanoprost ophthalmic solution 0.005%
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2017)
750
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2016)
690
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02674854
Other Study ID Numbers  ICMJE PG324-CS302
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aerie Pharmaceuticals
Study Sponsor  ICMJE Aerie Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Theresa Heah, MD, MBA Aerie Pharmaceuticals, Inc.
PRS Account Aerie Pharmaceuticals
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP