Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2011-02-28
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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AR-12286
AR-12286 Ophthalmic Solution 0.5%
Latanoprost 0.005%
q.d.
AR-12286 Ophthalmic Solution 0.5%
Timolol
Timolol maleate ophthalmic solution 0.5%
Latanoprost 0.005%
q.d.
Timolol maleate ophthalmic solution 0.5%
Interventions
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Latanoprost 0.005%
q.d.
AR-12286 Ophthalmic Solution 0.5%
Timolol maleate ophthalmic solution 0.5%
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Aerie Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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David Silverstone, M.D.
New Haven, Connecticut, United States
Coastal Research Associates, LLC
Roswell, Georgia, United States
Heart of America Eye Care, P.A.
Shawnee Mission, Kansas, United States
Taustine Eye Center
Louisville, Kentucky, United States
Alan L Robin, M.D.
Baltimore, Maryland, United States
Comprehensive Eye Care
St Louis, Missouri, United States
Rochester Ophthalmology Group
Rochester, New York, United States
Glaucoma Consultants of the Capital Region
Slingerlands, New York, United States
Thomas K. Mundorf, M.D.
Charlotte, North Carolina, United States
Charlotte Eye Ear Nose and Throat
Charlotte, North Carolina, United States
The Eye Institute
Tulsa, Oklahoma, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Cataract & Glaucoma Center
El Paso, Texas, United States
Stacy R. Smith, M.D.
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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AR-12286-CS203
Identifier Type: -
Identifier Source: org_study_id
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