Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure
NCT ID: NCT02057575
Last Updated: 2019-06-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
298 participants
INTERVENTIONAL
2014-01-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PG324 Ophthalmic Solution 0.01%
Netarsudil 0.01%, Latanoprost 0.005% fixed combination ophthalmic solution
PG324 Ophthalmic Solution 0.01%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
PG324 Ophthalmic Solution 0.02%
Netarsudil 0.02%, Latanoprost 0.005% fixed combination ophthalmic solution
PG324 Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
Netarsudil 0.02% ophthalmic solution
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
Latanoprost Ophthalmic Solution 0.005%
Latanoprost 0.005% ophthalmic solution
Latanoprost Ophthalmic Solution 0.005%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
Interventions
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PG324 Ophthalmic Solution 0.01%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
PG324 Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
Latanoprost Ophthalmic Solution 0.005%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Aerie Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Nancy Ramirez, M.S.
Role: STUDY_DIRECTOR
Aerie Pharmaceuticals, Inc.
Locations
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Kenneth Sall, M.D.
Artesia, California, United States
United Medical Research Institute
Inglewood, California, United States
Aesthetic Eye Care Institute
Newport Beach, California, United States
Bacharach practice
Petaluma, California, United States
Centre For Health Care
Poway, California, United States
Clayton Eye Center
Morrow, Georgia, United States
Coastal Research Associates, LLC
Roswell, Georgia, United States
Bradley Kwapiszeski, MD
Shawnee Mission, Kansas, United States
Taustine Eye Center
Louisville, Kentucky, United States
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, United States
Great Lakes Eye Care
Saint Joseph, Michigan, United States
Comprehensive Eye Care
St Louis, Missouri, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States
Rochester Ophthalmological Group
Rochester, New York, United States
Charlotte Eye Ear Nose & Throat Associates, P.A.
Belmont, North Carolina, United States
Michael E. Tepedino, M.D.
High Point, North Carolina, United States
The Eye Institute
Tulsa, Oklahoma, United States
Texan Eye
Austin, Texas, United States
Glaucoma Associates of Texas - Dallas Office
Dallas, Texas, United States
Cataract & Glaucoma Center
El Paso, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Stacy R. Smith, M.D.
Salt Lake City, Utah, United States
Virginia Eye Consultants
Norfolk, Virginia, United States
Countries
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References
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Lewis RA, Levy B, Ramirez N, Kopczynski CC, Usner DW, Novack GD; PG324-CS201 Study Group. Fixed-dose combination of AR-13324 and latanoprost: a double-masked, 28-day, randomised, controlled study in patients with open-angle glaucoma or ocular hypertension. Br J Ophthalmol. 2016 Mar;100(3):339-44. doi: 10.1136/bjophthalmol-2015-306778. Epub 2015 Jul 24.
Other Identifiers
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PG324-CS201
Identifier Type: -
Identifier Source: org_study_id
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