- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01699464
A Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients With Elevated Intraocular Pressure for 3 Months
August 18, 2023 updated by: Aerie Pharmaceuticals
Phase 2b Dose-response of AR-12286 in Patients With Elevated Intraocular Pressure for 3 Months
A double-masked, parallel study of AR-12286 Ophthalmic Solution 0.5%, or 0.7% (q.d., PM) or timolol maleate Ophthalmic Solution, 0.5% (b.i.d.), O.U. for 3 months.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
211
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18 year of age or greater. (India_ Maximum age of 65 years)
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
- Unmedicated (post-washout) IOP ≥ 24 mm Hg at 2 eligibility visits (0800 hr), 2-7 days apart, and ≥ 22 mm Hg at 1000 and 1600 hrs at the second qualification visit. If only one eye meets the IOP criteria it must be the same eye that met the criteria at all the qualification timepoints.
- 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:
Ophthalmic
- Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
- IOP > 36 mm Hg
- Current use of more than 1 ocular hypotensive medications (Note: fixed dose combinations are considered multiple medications).
- Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
- Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s).
- Refractive surgery in study eye(s) (e.g., radial keratotomy, PRK, LASIK, etc.).
- Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
- Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or a history of herpes simplex keratitis
- Ocular medication of any kind within 30 days of Visit 1, with the exception of a) ocular hypotensive medications (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after Visit 1) or c) lubricating drops for dry eye (which may be used throughout the study).
- Clinically significant ocular disease (e.g. uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe (i.e., cup-disc ratio > 0.8).
- Central corneal thickness greater than 600 µm.
Any abnormality preventing reliable applanation tonometry of either eye.
Systemic:
Systemic:
- Clinically significant abnormalities (as determined by the treating physician) in laboratory tests at screening.
- Known hypersensitivity or contraindication to beta adrenoceptor antagonists including chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure or heart rate; second or third degree heart block or congestive heart failure; severe diabetes).
- Clinically significant systemic disease (e.g., myasthenia gravis, hepatic, renal, endocrine or cardiovascular 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 within 30 days prior to screening, or anticipated during the study.
- Due to the current status of the preclinical safety program, women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at the screening examination and must not intend to become pregnant during the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AR-12286 Ophthalmic Solution 0.7%
AR-12286 Ophthalmic Solution 0.7%, both eyes
|
Ophthalmic Solution
|
Experimental: AR-12286 Ophthalmic Solution 0.5%
AR-12286 Ophthalmic Solution 0.5% both eyes
|
Ophthalmic Solution
|
Active Comparator: Timolol maleate ophthalmic solution 0.5%
Timolol maleate ophthalmic solution 0.5% both eyes
|
Ophthalmic Solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean IOP across subjects within treatment group at each post-treatment timepoint of Month 3
Time Frame: Month 3
|
Intraocular pressure
|
Month 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Brian Levy, OD, Aerie Pharmaceuticals, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
October 2, 2012
First Submitted That Met QC Criteria
October 2, 2012
First Posted (Estimated)
October 3, 2012
Study Record Updates
Last Update Posted (Actual)
August 22, 2023
Last Update Submitted That Met QC Criteria
August 18, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Glaucoma
- Glaucoma, Open-Angle
- Ocular Hypertension
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Timolol
- Ophthalmic Solutions
- Pharmaceutical Solutions
Other Study ID Numbers
- AR-12286-CS206
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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