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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
Last Update Posted : April 17, 2018
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 Drug: Netarsudil (AR-13324) Ophthalmic Solution Drug: Latanoprost Ophthalmic Solution Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 690 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : September 18, 2015
Actual Primary Completion Date : May 17, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: PG324 Ophthalmic Solution
1 drop daily (evening) both eyes
Drug: PG324 Ophthalmic Solution
1 drop daily (evening) both eyes

Active Comparator: Netarsudil (AR-13324) Ophthalmic Solution
1 drop daily (evening) both eyes
Drug: Netarsudil (AR-13324) Ophthalmic Solution
1 drop daily (evening) both eyes

Active Comparator: Latanoprost Ophthalmic Solution
1 drop daily (evening) both eyes
Drug: Latanoprost Ophthalmic Solution
1 drop daily (evening) both eyes




Primary Outcome Measures :
  1. Intraocular pressure [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 12 months ]
  2. Changes in visual acuity from baseline [ Time Frame: 12 months ]
  3. Changes in visual field test from baseline [ Time Frame: 12 months ]
  4. Changes in pupil size from baseline [ Time Frame: 12 months ]


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 1 or both eyes at qualification visits
  4. Corrected visual acuity equivalent to 20/200
  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

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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
Last Update Posted: April 17, 2018
Last Verified: January 2017

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