AR-12286 in Combination With Latanoprost

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease	Intervention/treatment	Phase
Glaucoma; Ocular Hypertension	Drug: Latanoprost 0.005%; Drug: AR-12286 Ophthalmic Solution 0.5%; Drug: Timolol maleate ophthalmic solution 0.5%	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	66 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Phase 2, Double-masked, Randomized, Active-controlled, Crossover Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 or Timolol Added to Patients With Elevated Intraocular Pressure Currently Using Latanoprost
Study Start Date :	February 2011
Actual Primary Completion Date :	December 2011
Actual Study Completion Date :	December 2011

Arms and Interventions

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Arm	Intervention/treatment
Experimental: AR-12286; AR-12286 Ophthalmic Solution 0.5%	Drug: Latanoprost 0.005%; q.d.; Other Name: Xalatan(R) Drug: AR-12286 Ophthalmic Solution 0.5%
Active Comparator: Timolol; Timolol maleate ophthalmic solution 0.5%	Drug: Latanoprost 0.005%; q.d.; Other Name: Xalatan(R) Drug: Timolol maleate ophthalmic solution 0.5%

Outcome Measures

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Primary Outcome Measures :

1. Intraocular pressure [ Time Frame: 28 days ]
   The primary efficacy endpoint will be the mean IOP across subjects within treatment group at each study visit at each post-treatment timepoint.

Secondary Outcome Measures :

1. Ocular safety [ Time Frame: 28 days ]
   Safety endpoints will be visual acuity, objective biomicroscopic and ophthalmoscopic examination, and subjective comfort as measured by adverse events in response to subject symptom queries.
2. Systemic safety [ Time Frame: 28 days ]
   Heart rate, and blood pressure.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 18 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

Exclusion Criteria:

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.
• Refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
• Central corneal thickness greater than 600 µ.

Systemic:

• Known bronchial asthma (history or current), severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block or overt cardiac failure.
• Clinically significant abnormalities in laboratory tests at screening, recognizing that subjects are not fasting at the time of drawing blood.
• Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study.
• Participation in any investigational study within the past 30 days.
• Changes of systemic medication that could have a substantial effect on IOP 4 weeks prior to screening, or anticipated during the study.
• Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Connecticut
David Silverstone, M.D.
New Haven, Connecticut, United States, 06510
United States, Georgia
Coastal Research Associates, LLC
Roswell, Georgia, United States, 30076
United States, Kansas
Heart of America Eye Care, P.A.
Shawnee Mission, Kansas, United States, 66204
United States, Kentucky
Taustine Eye Center
Louisville, Kentucky, United States, 40217
United States, Maryland
Alan L Robin, M.D.
Baltimore, Maryland, United States, 21209
United States, Missouri
Comprehensive Eye Care
St Louis, Missouri, United States, 63090
United States, New York
Rochester Ophthalmology Group
Rochester, New York, United States, 14618
Glaucoma Consultants of the Capital Region
Slingerlands, New York, United States, 12159
United States, North Carolina
Thomas K. Mundorf, M.D.
Charlotte, North Carolina, United States, 28204
Charlotte Eye Ear Nose and Throat
Charlotte, North Carolina, United States, 28210
United States, Oklahoma
The Eye Institute
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, South Dakota
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 57701
United States, Texas
Cataract & Glaucoma Center
El Paso, Texas, United States, 79902
United States, Utah
Stacy R. Smith, M.D.
Salt Lake City, Utah, United States, 84117

Sponsors and Collaborators

Aerie Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Aerie Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01302249 History of Changes
Other Study ID Numbers:	AR-12286-CS203
First Posted:	February 24, 2011
Last Update Posted:	May 8, 2014
Last Verified:	April 2014

Keywords provided by Aerie Pharmaceuticals:

Glaucoma; Intraocular pressure; Ocular hypertension

Additional relevant MeSH terms:

Hypertension; Glaucoma; Ocular Hypertension; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Pharmaceutical Solutions; Ophthalmic Solutions; Timolol; Latanoprost	Maleic acid; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors