Ocular HypertensionPhase 2NCT01699464
A Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients With Elevated Intraocular Pressure for 3 Months
A Phase 2 study testing AR-12286 Ophthalmic Solution 0.7%, AR-12286 Ophthalmic Solution 0.5% and Timolol maleate ophthalmic solution 0.5% in people with Ocular Hypertension and Open-angle Glaucoma, run by Aerie Pharmaceuticals.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ocular Hypertension, Open-angle Glaucoma
- What is being tested?
- AR-12286 Ophthalmic Solution 0.7%, AR-12286 Ophthalmic Solution 0.5% and Timolol maleate ophthalmic solution 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Apr 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 21Show fewer
- 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.
About this study
Official title: 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.
- Conditions
- Ocular Hypertension, Open-angle Glaucoma
- Being tested
- AR-12286 Ophthalmic Solution 0.7%, AR-12286 Ophthalmic Solution 0.5%, Timolol maleate ophthalmic solution 0.5%
- Keywords
- Glaucoma
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR-12286 Ophthalmic Solution 0.7%Drug
Ophthalmic Solution
AR-12286 Ophthalmic Solution 0.5%Drug
Ophthalmic Solution
Timolol maleate ophthalmic solution 0.5%Drug
Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| AR-12286 Ophthalmic Solution 0.7% | Experimental | AR-12286 Ophthalmic Solution 0.7%, both eyes Receives: Drug: AR-12286 Ophthalmic Solution 0.7% |
| AR-12286 Ophthalmic Solution 0.5% | Experimental | AR-12286 Ophthalmic Solution 0.5% both eyes Receives: Drug: AR-12286 Ophthalmic Solution 0.5% |
| Timolol maleate ophthalmic solution 0.5% | Active comparator | Timolol maleate ophthalmic solution 0.5% both eyes Receives: Drug: Timolol maleate ophthalmic solution 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean IOP across subjects within treatment group at each post-treatment timepoint of Month 3
Intraocular pressure
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerie Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Levy, OD, Study director, Aerie Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699464
- Sponsor's protocol ID
- AR-12286-CS206
- Status last verified
- Aug 2023
- First submitted
- 2 Oct 2012
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2b Dose-response of AR-12286 in Patients With Elevated Intraocular Pressure for 3 Months
- ClinicalTrials.gov ID
- NCT01699464
- Acronym / sponsor ID
- AR-12286-CS206
- Conditions
- Ocular Hypertension, Open-angle Glaucoma
- Keywords
- Glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AR-12286 Ophthalmic Solution 0.7% | Experimental | Drug: AR-12286 Ophthalmic Solution 0.7%AR-12286 Ophthalmic Solution 0.7%, both eyes |
| AR-12286 Ophthalmic Solution 0.5% | Experimental | Drug: AR-12286 Ophthalmic Solution 0.5%AR-12286 Ophthalmic Solution 0.5% both eyes |
| Timolol maleate ophthalmic solution 0.5% | Active comparator | Drug: Timolol maleate ophthalmic solution 0.5%Timolol maleate ophthalmic solution 0.5% both eyes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AR-12286 Ophthalmic Solution 0.7%Ophthalmic Solution | Drug | AR-12286 Ophthalmic Solution 0.7% |
| AR-12286 Ophthalmic Solution 0.5%Ophthalmic Solution | Drug | AR-12286 Ophthalmic Solution 0.5% |
| Timolol maleate ophthalmic solution 0.5%Ophthalmic Solution | Drug | Timolol maleate ophthalmic solution 0.5% |
Primary outcome
Mean IOP across subjects within treatment group at each post-treatment timepoint of Month 3
Time frame: Month 3
Intraocular pressure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
Related trials for Ocular Hypertension
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Levy, OD study director
Aerie Pharmaceuticals, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AR-12286 Ophthalmic Solution 0.7%, AR-12286 Ophthalmic Solution 0.5% and Timolol maleate ophthalmic solution 0.5% in people with Ocular Hypertension and Open-angle Glaucoma, run by Aerie Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean IOP across subjects within treatment group at each post-treatment timepoint of Month 3 (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.