Study of AR-12286 Versus Latanoprost in Patients With Elevated Intraocular Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01060579
First received: January 30, 2010
Last updated: March 9, 2012
Last verified: March 2012

January 30, 2010
March 9, 2012
February 2010
August 2010   (final data collection date for primary outcome measure)
The primary efficacy endpoint will be the mean intraocular pressure (IOP) across subjects within treatment group on each day at each post-treatment timepoint [ Time Frame: 28 days of dosing ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01060579 on ClinicalTrials.gov Archive Site
Mean change from diurnally adjusted baseline IOP at each timepoint [ Time Frame: 28 days of dosing ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of AR-12286 Versus Latanoprost in Patients With Elevated Intraocular Pressure
A Phase 2, Double-masked, Randomized, Active-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients With Elevated Intraocular Pressure

A 28 day study of the safety and efficacy of two concentrations of topical AR-12286 in treating ocular hypertension and open-angle glaucoma compared to latanoprost. Hypothesis: The ocular hypotensive efficacy of each dose of AR-12286 ophthalmic solution will not be different from that of an active control.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Glaucoma
  • Drug: AR-12286 0.5% ophthalmic solution
    q.d. PM
  • Drug: AR-12286 0.25% Ophthalmic solution
    b.i.d.
  • Drug: Latanoprost ophthalmic solution
    q.d. PM
    Other Name: Xalatan(R)
Experimental: Ophthalmic solutions
Pharmaceutical interventions
Interventions:
  • Drug: AR-12286 0.5% ophthalmic solution
  • Drug: AR-12286 0.25% Ophthalmic solution
  • 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
217
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 18 years of age or greater.
  2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) and currently being treated with ocular hypotensive medication.
  3. Unmedicated (post-washout) IOP ≥ 22 mm Hg at 2 eligibility visits (07:00-09:00 hr), 2-7 days apart.
  4. Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
  5. Has used a commercially available IOP-lowering medication in one or both eyes for at least 30 days over the 90 days prior to the screening visit.
  6. Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria:

Ophthalmic (in either eye):

  1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure. Note: Previous laser peripheral iridotomy is acceptable.
  2. Intraocular pressure > 36 mm Hg
  3. Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
  4. Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s).
  5. Refractive surgery in study eye(s) (e.g., radial keratotomy, PRK, LASIK, etc.).
  6. Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
  7. History or evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or of herpes simplex keratitis
  8. Contact lens wear within 30 minutes of instillation of study medication.
  9. Ocular medication of any kind within 30 days of Visit 1, with the exception of a) ocular hypotensive medications (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after Visit 1) or c) lubricating drops for dry eye (which may be used throughout the study).
  10. 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 (i.e., cup-disc ratio > 0.8).
  11. Central corneal thickness greater than 600 μ.
  12. Any abnormality preventing reliable applanation tonometry of either eye.

Systemic:

  1. Clinically significant abnormalities in laboratory tests at screening.
  2. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
  3. Participation in any investigational study within the past 30 days.
  4. Changes of systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study.
  5. Due to status of preclinical safety program, 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01060579
AR-12286-CS202
No
Aerie Pharmaceuticals
Aerie Pharmaceuticals
Not Provided
Study Director: Thomas van Haarlem, MD Aerie Pharmaceuticals, Inc.
Aerie Pharmaceuticals
March 2012

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