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: June 25, 2014
Last verified: June 2014

February 6, 2014
June 25, 2014
January 2014
June 2014   (final data collection date for primary outcome measure)
Intraocular Pressure [IOP] [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
The mean diurnal IOP across subjects within treatment group.
Same as current
Complete list of historical versions of study NCT02057575 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure
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

The purpose of this double-masked, randomized, parallel-group study is to evaluate the ocular hypotensive efficacy of a fixed combination of latanoprost and AR-13324 (PG324) 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%
    A fixed dose combination of AR-13324 Ophthalmic Solution, 0.01% and Latanoprost Ophthalmic Solution, 0.005%
  • Drug: PG324 Ophthalmic Solution, 0.02%
    A fixed dose combination of AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005%
  • Drug: AR-13324 Ophthalmic Solution, 0.02%
  • Drug: Latanoprost Ophthalmic Solution, 0.005%
  • Experimental: PG324 Ophthalmic Solution, 0.01%
    Intervention: Drug: PG324 Ophthalmic Solution, 0.01%
  • Experimental: PG324 Ophthalmic Solution, 0.02%
    Intervention: Drug: PG324 Ophthalmic Solution, 0.02%
  • Active Comparator: AR-13324 Ophthalmic Solution, 0.02%
    AR-13324 Ophthalmic Solution, 0.02%
    Intervention: Drug: AR-13324 Ophthalmic Solution, 0.02%
  • Active Comparator: Latanoprost Ophthalmic Solution, 0.005%
    Latanoprost Ophthalmic Solution, 0.005%
    Intervention: Drug: Latanoprost Ophthalmic Solution, 0.005%
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 (OAG) or ocular hypertension (OHT).
  • Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS 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) (e.g., radial keratotomy, PRK, LASIK, etc.)
  • 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 (e.g., cup-disc ratio > 0.8).
  • 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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02057575
PG324-CS201
Not Provided
Aerie Pharmaceuticals
Aerie Pharmaceuticals
Not Provided
Study Director: Nancy Ramirez, M.S. Aerie Pharmaceuticals, Inc.
Aerie Pharmaceuticals
June 2014

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