NCT01060579

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

May 8, 2014

Status Verified

April 1, 2014

Enrollment Period

6 months

First QC Date

January 30, 2010

Last Update Submit

April 18, 2014

Conditions

Glaucoma

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy endpoint will be the mean intraocular pressure (IOP) across subjects within treatment group on each day at each post-treatment timepoint

    28 days of dosing

Secondary Outcomes (1)

  • Mean change from diurnally adjusted baseline IOP at each timepoint

    28 days of dosing

Study Arms (3)

AR-12286 0.5% ophthalmic solution

EXPERIMENTAL
Drug: AR-12286 0.5% ophthalmic solution

AR-12286 0.25% Ophthalmic Solution

EXPERIMENTAL
Drug: AR-12286 0.25% Ophthalmic solution

Latanoprost 0.005% ophthalmic solution

EXPERIMENTAL
Drug: Latanoprost ophthalmic solution

Interventions

AR-12286 0.5% ophthalmic solutionDRUG

q.d. PM

AR-12286 0.5% ophthalmic solution
AR-12286 0.25% Ophthalmic solutionDRUG

q.d. PM

AR-12286 0.25% Ophthalmic Solution
Latanoprost ophthalmic solutionDRUG

q.d. PM

Also known as: Xalatan(R)
Latanoprost 0.005% ophthalmic solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or greater.
  • Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) and currently being treated with ocular hypotensive medication.
  • Unmedicated (post-washout) IOP ≥ 22 mm Hg at 2 eligibility visits (07:00-09:00 hr), 2-7 days apart.
  • Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
  • 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.
  • Able and willing to give signed informed consent and follow study instructions.

You may not qualify if:

  • Ophthalmic (in either eye):
  • Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure. Note: Previous laser peripheral iridotomy is acceptable.
  • Intraocular pressure \> 36 mm Hg
  • Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), 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 past six months, or ocular surgery or laser treatment within the past three months.
  • History or evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or of herpes simplex keratitis
  • Contact lens wear within 30 minutes of instillation of study medication.
  • 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).
  • 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).
  • Central corneal thickness greater than 600 μ.
  • Any abnormality preventing reliable applanation tonometry of either eye.
  • Systemic:
  • Clinically significant abnormalities in laboratory tests at screening.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

United Medical Research Institute

Inglewood, California, 90301, United States

Location

North Bay Eye Associates

Petaluma, California, 94954, United States

Location

Centre For Health Care

Poway, California, 92064, United States

Location

East Florida Eye Institute

Stuart, Florida, 34994, United States

Location

Marvin Greenberg, MD

Tamarac, Florida, 33321, United States

Location

Coastal Research Associates, LLC

Roswell, Georgia, 30076, United States

Location

Bradley Kwapiszeski, MD

Shawnee Mission, Kansas, 66204, United States

Location

Taustine Eye Center

Louisville, Kentucky, 40217, United States

Location

Comprehensive Eye Care

St Louis, Missouri, 63090, United States

Location

Mount Sinai School Of Medicine

New York, New York, 10029, United States

Location

Rochester Ophthalmology Group

Rochester, New York, 14618, United States

Location

Glaucoma Consultants of the Capital Region

Slingerlands, New York, 12159, United States

Location

Charlotte Eye Ear Nose and Throat

Charlotte, North Carolina, 28210, United States

Location

The Eye Institute

Tulsa, Oklahoma, 74104, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Univ Eye Surgeons, Maryville Ctr.

Maryville, Tennessee, 37803, United States

Location

Texan Eye

Austin, Texas, 78731, United States

Location

Medical Center Ophth. Associates

San Antonio, Texas, 78731, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

AR-12286Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Thomas van Haarlem, MD

    Aerie Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2010

First Posted

February 2, 2010

Study Start

February 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

May 8, 2014

Record last verified: 2014-04

Locations

US(18)