AR-12286 in Combination With Latanoprost

Sponsor

Aerie Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01302249

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

4.4

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Feb 1, 2011

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AR-12286 AR-12286 Ophthalmic Solution 0.5%	Drug: Latanoprost 0.005% q.d. Other Names: 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 Names: Xalatan(R) Drug: Timolol maleate ophthalmic solution 0.5%

Arm

Intervention/Treatment

Experimental: AR-12286

AR-12286 Ophthalmic Solution 0.5%

Drug: Latanoprost 0.005%

q.d.

Other Names:

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 Names:

Xalatan(R)

Drug: Timolol maleate ophthalmic solution 0.5%

Outcome Measures

Primary Outcome Measures

Intraocular pressure [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

Ocular safety [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.
Systemic safety [28 days]
Heart rate, and blood pressure.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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