AR-12286 in Combination With Latanoprost
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ClinicalTrials.gov Identifier: NCT01302249 |
Recruitment Status
:
Completed
First Posted
: February 24, 2011
Last Update Posted
: May 8, 2014
|
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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 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 |

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%
|
- 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.
- 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.
- Systemic safety [ Time Frame: 28 days ]Heart rate, and blood pressure.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302249
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 |
Responsible Party: | Aerie Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01302249 History of Changes |
Other Study ID Numbers: |
AR-12286-CS203 |
First Posted: | February 24, 2011 Key Record Dates |
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 |