AR-12286 in Combination With Latanoprost

NCT01302249 | Completed Phase 2

• 1 other identifier: AR-12286-CS203
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 15

Brief Summary

This is a double-masked, randomized, multi-center, active-controlled, crossover comparison of the addition of AR-12286 or timolol to latanoprost in the treatment of elevated intraocular pressure (IOP).

Conditions

Glaucoma; Ocular Hypertension

Keywords

Glaucoma; Intraocular pressure; Ocular hypertension

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure

  The primary efficacy endpoint will be the mean IOP across subjects within treatment group at each study visit at each post-treatment timepoint.

  28 days

Secondary Outcomes (2)

• Ocular safety

  28 days

• Systemic safety

  28 days

Study Arms (2)

AR-12286

EXPERIMENTAL

AR-12286 Ophthalmic Solution 0.5%

Drug: Latanoprost 0.005%; Drug: AR-12286 Ophthalmic Solution 0.5%

Timolol

ACTIVE COMPARATOR

Timolol maleate ophthalmic solution 0.5%

Drug: Latanoprost 0.005%; Drug: Timolol maleate ophthalmic solution 0.5%

Interventions

Latanoprost 0.005% DRUG

q.d.

Also known as: Xalatan(R)

AR-12286; Timolol

AR-12286 Ophthalmic Solution 0.5% DRUG

AR-12286

Timolol maleate ophthalmic solution 0.5% DRUG

Timolol

Eligibility Criteria

• Age: 18 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).
• Currently using prostaglandin analogue (monotherapy or combination therapy) O.U. ≥ 1 month at time of study entry (first qualification visit) in study eye(s).
• Qualification Visit 1 (Screening) IOP at 16:00 hrs: PG monotherapy patients: ≥ 18 mm Hg; Combination therapy patients: \>= 16 mm Hg. Qualification Visit 2 (post latanoprost run-in) IOP ≥ 20 mm Hg at 08:00 hrs and 10:00 hrs, IOP ≥ 18 mm Hg at 16:00 hrs in study eye(s). (Note: combination therapy may include any combination of topical ocular hypotensive agents).
• 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:

• In either eye:
• Previously randomized to treatment in a clinical study of AR-12286.
• Intraocular pressure \> 36 mm Hg.
• History of acute angle-closure glaucoma, or closed or narrow angle upon gonioscopy
• Known hypersensitivity or contraindication to timolol maleate ophthalmic solution, or any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics, including history of conjunctival hyperemia with topical latanoprost of severity greater than 1 on a 0-3 scale.
• Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
• Contact lens wear within 30 minutes of instillation of study medication.
• PG monotherapy patients: Ocular hypotensive medication (other than prostaglandin) within 4 weeks of Visit 0 (Study entry, first qualification visit). Combination therapy patients: Ocular hypotensive medication (other than prostaglandin and current additional agent) within 4 weeks of Visit 0 (Study entry, first qualification visit).
• Conjunctival hyperemia of grade 2+ or greater at Visit 1.
• Any other ocular medication within 4 weeks of Visit 1 with the exception of 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 treatment with only latanoprost for two periods of up to 4 weeks is not judged safe (e.g., advanced glaucomatous optic nerve head or visual field loss).
• Any abnormality preventing reliable applanation tonometry of either eye.
• In study eye(s):
• Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure. Note: Previous laser peripheral iridotomy is acceptable.
• Previous glaucoma intraocular surgery or laser procedures.

Sponsors & Collaborators

• Aerie Pharmaceuticals: lead

Study Sites (15)

David Silverstone, M.D.

New Haven, Connecticut, 06510, United States

Location

Coastal Research Associates, LLC

Roswell, Georgia, 30076, United States

Location

Heart of America Eye Care, P.A.

Shawnee Mission, Kansas, 66204, United States

Location

Taustine Eye Center

Louisville, Kentucky, 40217, United States

Location

Alan L Robin, M.D.

Baltimore, Maryland, 21209, 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

Thomas K. Mundorf, M.D.

Charlotte, North Carolina, 28204, 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

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Cataract & Glaucoma Center

El Paso, Texas, 79902, United States

Location

Stacy R. Smith, M.D.

Salt Lake City, Utah, 84117, United States

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

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

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 24, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 8, 2014

Record last verified: 2014-04

Locations

US (15)