24-hour Efficacy of AR-12286

NCT01330979 | Completed Phase 2

• 1 other identifier: AR-12286-CS204
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

An open-label, non-comparative, pilot evaluation of the 24-hour ocular hypotensive efficacy of AR-12286 in patients with open-angle glaucoma or ocular hypertension

Conditions

Open Angle Glaucoma; Ocular Hypertension

Keywords

Intraocular pressure

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure

  Intraocular pressure compared to baseline

  Day 28

Secondary Outcomes (1)

• Intraocular pressure

  Day 28

Interventions

AR-12286 0.5% Ophthalmic Solution DRUG

Ophthalmic Solution

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years of age.
• 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 including two nights in UCSD sleep lab for physiological measurements.

You may not qualify if:

• Excluded from the study will be individuals with the following characteristics:
• Ophthalmic (in either eye):
• Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure or narrow irridocorneal angle. 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:

Sponsors & Collaborators

• Aerie Pharmaceuticals: lead

Study Sites (1)

University of California

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

AR-12286; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 7, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: April 21, 2014

Record last verified: 2014-03

Locations

US (1)