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Trial record 19 of 19 for:    netarsudil

Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure

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ClinicalTrials.gov Identifier: NCT02057575
Recruitment Status : Completed
First Posted : February 7, 2014
Results First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Brief Summary:
To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Ocular Hypertension Drug: PG324 Ophthalmic Solution 0.01% Drug: PG324 Ophthalmic Solution 0.02% Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02% Drug: Latanoprost Ophthalmic Solution 0.005% Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 298 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-masked, Randomized, Controlled Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution, 0.01% and PG324 Ophthalmic Solution, 0.02%, Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Patients With Elevated Intraocular Pressure
Study Start Date : January 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014


Arm Intervention/treatment
Experimental: PG324 Ophthalmic Solution 0.01%
Netarsudil 0.01%, Latanoprost 0.005% fixed combination ophthalmic solution
Drug: PG324 Ophthalmic Solution 0.01%
1 drop in the evening (PM), once daily (QD), both eyes (OU)

Experimental: PG324 Ophthalmic Solution 0.02%
Netarsudil 0.02%, Latanoprost 0.005% fixed combination ophthalmic solution
Drug: PG324 Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), 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 in the evening (PM), once daily (QD), both eyes (OU)

Active Comparator: Latanoprost Ophthalmic Solution 0.005%
Latanoprost 0.005% ophthalmic solution
Drug: Latanoprost Ophthalmic Solution 0.005%
1 drop in the evening (PM), once daily (QD), both eyes (OU)




Primary Outcome Measures :
  1. Intraocular Pressure (IOP) [ Time Frame: Study treatment was administered for 28 days, and outcome measures collected on Day 29 ]
    The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29.



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:

  • 18 years of age or greater.
  • 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:

Ophthalmic:

  • 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.

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): NCT02057575


Locations
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United States, California
Kenneth Sall, M.D.
Artesia, California, United States, 90701
United Medical Research Institute
Inglewood, California, United States, 90301
Aesthetic Eye Care Institute
Newport Beach, California, United States, 92657
Bacharach practice
Petaluma, California, United States, 94954
Centre For Health Care
Poway, California, United States, 92064
United States, Georgia
Clayton Eye Center
Morrow, Georgia, United States, 30260
Coastal Research Associates, LLC
Roswell, Georgia, United States, 30076
United States, Kansas
Bradley Kwapiszeski, MD
Shawnee Mission, Kansas, United States, 66204
United States, Kentucky
Taustine Eye Center
Louisville, Kentucky, United States, 40217
United States, Maryland
Seidenberg Protzko Eye Associates
Havre De Grace, Maryland, United States, 21078
United States, Michigan
Great Lakes Eye Care
Saint Joseph, Michigan, United States, 49085
United States, Missouri
Comprehensive Eye Care
Saint Louis, Missouri, United States, 63090
United States, New York
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States, 11563
Rochester Ophthalmological Group
Rochester, New York, United States, 14618
United States, North Carolina
Charlotte Eye Ear Nose & Throat Associates, P.A.
Belmont, North Carolina, United States, 28012
Michael E. Tepedino, M.D.
High Point, North Carolina, United States, 27262
United States, Oklahoma
The Eye Institute
Tulsa, Oklahoma, United States, 74104
United States, Texas
Texan Eye
Austin, Texas, United States, 78731
Glaucoma Associates of Texas - Dallas Office
Dallas, Texas, United States, 75231
Cataract & Glaucoma Center
El Paso, Texas, United States, 79902
Medical Center Ophthalmology Associates
San Antonio, Texas, United States, 78240
United States, Utah
Stacy R. Smith, M.D.
Salt Lake City, Utah, United States, 84117
United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Aerie Pharmaceuticals
Investigators
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Study Director: Nancy Ramirez, M.S. Aerie Pharmaceuticals, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02057575     History of Changes
Other Study ID Numbers: PG324-CS201
First Posted: February 7, 2014    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

Keywords provided by Aerie Pharmaceuticals:
Open Angle Glaucoma
Ocular Hypertension
Intraocular Pressure
AR13324
PG324

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