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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02057575
First received: February 6, 2014
Last updated: January 21, 2016
Last verified: January 2016

February 6, 2014
January 21, 2016
January 2014
June 2014   (final data collection date for primary outcome measure)
Mean diurnal Intraocular Pressure [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
Mean diurnal intraocular pressure across subjects within treatment group at Day 29
Intraocular Pressure [IOP] [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
The mean diurnal IOP across subjects within treatment group.
Complete list of historical versions of study NCT02057575 on ClinicalTrials.gov Archive Site
  • Mean Intraocular Pressure [ Time Frame: Day 8, Day 15, and Day 29 ] [ Designated as safety issue: No ]
    Mean intraocular pressure across subjects within treatment group at each post-treatment timepoint on Day 8, Day 15, Day 29.
  • Mean Change in Intraocular Pressure [ Time Frame: Day 8, Day 15, and Day 29 ] [ Designated as safety issue: No ]
    Mean change from diurnally adjusted baseline intraocular pressure at each timepoint on Day 8, Day 15, Day 29.
  • Intraocular Pressure [IOP] [ Time Frame: Day 8, Day 15, and Day 29 ] [ Designated as safety issue: No ]
    Mean IOP across subjects within treatment group at each post-treatment timepoint.
  • Intraocular Pressure [IOP] [ Time Frame: Day 8, Day 15, and Day 29 ] [ Designated as safety issue: No ]
    Mean change from diurnally adjusted baseline IOP at each timepoint.
Not Provided
Not Provided
 
Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure
Not Provided
To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Open Angle Glaucoma
  • Ocular Hypertension
  • Drug: PG324 Ophthalmic Solution 0.01%
    1 drop daily (evening)
  • Drug: PG324 Ophthalmic Solution 0.02%
    1 drop daily (evening)
  • Drug: Netarsudil (AR-13324) Ophthalmic Solution
    1 drop daily (evening)
  • Drug: Latanoprost Ophthalmic Solution
    1 drop daily (evening)
  • Experimental: PG324 Ophthalmic Solution 0.01%
    PG324 Ophthalmic Solution 0.01%
    Intervention: Drug: PG324 Ophthalmic Solution 0.01%
  • Experimental: PG324 Ophthalmic Solution 0.02%
    PG324 Ophthalmic Solution 0.02%
    Intervention: Drug: PG324 Ophthalmic Solution 0.02%
  • Active Comparator: Netarsudil (AR-13324) Ophthalmic Solution
    Netarsudil (AR-13324) Ophthalmic Solution
    Intervention: Drug: Netarsudil (AR-13324) Ophthalmic Solution
  • Active Comparator: Latanoprost Ophthalmic Solution
    Latanoprost Ophthalmic Solution
    Intervention: Drug: Latanoprost Ophthalmic Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
298
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age or greater.
  • Diagnosis of open angle glaucoma or ocular hypertension
  • Corrected visual acuity in each eye equivalent to 20/200
  • Able and willing to give signed informed consent and follow study instructions.
  • Additional protocol-specific criteria may apply

Exclusion Criteria:

  • Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles.
  • Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), 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.
  • Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe
  • Clinically significant abnormalities (as determined by the investigator) in laboratory tests at screening.
  • Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
  • Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at the screening examination and must not intend to become pregnant during the study.
  • Additional protocol-specific criteria may apply
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02057575
PG324-CS201
Not Provided
Not Provided
Not Provided
Aerie Pharmaceuticals
Aerie Pharmaceuticals
Not Provided
Study Director: Nancy Ramirez, M.S. Aerie Pharmaceuticals, Inc.
Aerie Pharmaceuticals
January 2016

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