AR-12286 Fixed Dose Combination to Lower Elevated Intraocular Pressure

NCT01474135 | Completed Phase 2

• 1 other identifier: PG286-CS201
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 9

Brief Summary

This is a double-masked, randomized, controlled study assessing the safety and ocular hypotensive efficacy of two AR 12286/travoprost fixed-dose combination products compared to Travatan® Z in patients with elevated intraocular pressure

Conditions

Glaucoma; Ocular Hypertension

Keywords

Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean IOP across subjects within treatment group on Days 1 and 7 at each post-treatment timepoint.

  Intraocular pressure

  7 days

Secondary Outcomes (1)

• Ocular and systemic safety

  7 days

Study Arms (3)

0.25% AR-12286/ 0.004% travoprost

EXPERIMENTAL

Fixed dose combination of 0.25% AR-12286 and 0.004% travoprost

Drug: 0.25% AR-12286 / 0.004% travoprost

0.5% AR-12286/ 0.004% travoprost

EXPERIMENTAL

Fixed dose combination of 0.5% AR-12286/ 0.004% travoprost

Drug: 0.5% AR-12286, 0.004% travoprost

0.004%Travoprost

ACTIVE COMPARATOR

Travatan(R) Z(travoprost ophthalmic solution)

Drug: 0.004% Travoprost

Interventions

0.25% AR-12286 / 0.004% travoprost DRUG

0.25% AR-12286/ 0.004% travoprost

0.5% AR-12286, 0.004% travoprost DRUG

0.5% AR-12286/ 0.004% travoprost

0.004% Travoprost DRUG

0.004%Travoprost

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or greater.
• Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
• Unmedicated (post-washout) IOP ≥ 24 mm Hg at 2 eligibility visits (08:00 hr), 2-7 days apart. At second eligibility visit, IOP \>22 mmHg at 10:00, 12:00 and 16:00 hrs.
• 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.

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 travoprost, 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.

Sponsors & Collaborators

• Aerie Pharmaceuticals: lead

Study Sites (9)

United Medical Research Institute

Inglewood, California, 90301, United States

Location

Aesthetic Eye Care Institute

Newport Beach, California, 92657, United States

Location

Bacharach practice

Petaluma, California, 94954, United States

Location

Centre For Health Care

Poway, California, 92064, United States

Location

Comprehensive Eye Care

St Louis, Missouri, 63090, 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

Abrams Eye Center

Cleveland, Ohio, 44115, United States

Location

Cataract & Glaucoma Center

El Paso, Texas, 79902, United States

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

AR-12286; Travoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

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

Study Record Dates

• First Submitted: November 11, 2011
• First Posted: November 18, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

US (9)