GlaucomaPhase 2NCT01060579
Study of AR-12286 Versus Latanoprost in Patients With Elevated Intraocular Pressure
A Phase 2 study testing AR-12286 0.5% ophthalmic solution, AR-12286 0.25% Ophthalmic solution and Latanoprost ophthalmic solution in people with Glaucoma, run by Aerie Pharmaceuticals at 18 sites in United States.
Trial summary
A 28 day study of the safety and efficacy of two concentrations of topical AR-12286 in treating ocular hypertension and open-angle glaucoma compared to latanoprost. Hypothesis: The ocular hypotensive efficacy of each dose of AR-12286 ophthalmic solution will not be different from that of an active control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- AR-12286 0.5% ophthalmic solution, AR-12286 0.25% Ophthalmic solution and Latanoprost ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 18 sitesUnited States
- Study dates
- Feb 2010to Aug 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or greater.
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) and currently being treated with ocular hypotensive medication.
- Unmedicated (post-washout) IOP ≥ 22 mm Hg at 2 eligibility visits (07:00-09:00 hr), 2-7 days apart.
- Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
- Has used a commercially available IOP-lowering medication in one or both eyes for at least 30 days over the 90 days prior to the screening visit.
- Able and willing to give signed informed consent and follow study instructions.
Who cannot join
- Ophthalmic (in either eye):
- Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure. Note: Previous laser peripheral iridotomy is acceptable.
- Intraocular pressure > 36 mm Hg
- 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.).
Show all 19Show fewer
- Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
- History or evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or of herpes simplex keratitis
- Contact lens wear within 30 minutes of instillation of study medication.
- 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. corneal edema, 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 μ.
- Any abnormality preventing reliable applanation tonometry of either eye.
- Systemic:
- Clinically significant abnormalities in laboratory tests at screening.
- Clinically significant systemic disease (e.g., uncontrolled diabetes, 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 status of 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Texan Eye
Austin, Texas, 78731
Charlotte Eye Ear Nose and Throat
Charlotte, North Carolina, 28210
United Medical Research Institute
Inglewood, California, 90301
Taustine Eye Center
Louisville, Kentucky, 40217
Univ Eye Surgeons, Maryville Ctr.
Maryville, Tennessee, 37803
Mount Sinai School Of Medicine
New York, New York, 10029
North Bay Eye Associates
Petaluma, California, 94954
Centre For Health Care
Poway, California, 92064
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Rochester Ophthalmology Group
Rochester, New York, 14618
Coastal Research Associates, LLC
Roswell, Georgia, 30076
Medical Center Ophth. Associates
San Antonio, Texas, 78731
Bradley Kwapiszeski, MD
Shawnee Mission, Kansas, 66204
Glaucoma Consultants of the Capital Region
Slingerlands, New York, 12159
Comprehensive Eye Care
St Louis, Missouri, 63090
East Florida Eye Institute
Stuart, Florida, 34994
Marvin Greenberg, MD
Tamarac, Florida, 33321
The Eye Institute
Tulsa, Oklahoma, 74104
About this study
Official title: A Phase 2, Double-masked, Randomized, Active-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients With Elevated Intraocular Pressure
A 28 day study of the safety and efficacy of two concentrations of topical AR-12286 in treating ocular hypertension and open-angle glaucoma compared to latanoprost. Hypothesis: The ocular hypotensive efficacy of each dose of AR-12286 ophthalmic solution will not be different from that of an active control.
- Conditions
- Glaucoma
- Being tested
- AR-12286 0.5% ophthalmic solution, AR-12286 0.25% Ophthalmic solution, Latanoprost ophthalmic solution
- Keywords
- Glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR-12286 0.5% ophthalmic solutionDrug
q.d. PM
AR-12286 0.25% Ophthalmic solutionDrug
q.d. PM
Latanoprost ophthalmic solutionDrug
Also called Xalatan(R)
q.d. PM
| Study group | Role | What they receive |
|---|---|---|
| AR-12286 0.5% ophthalmic solution | Experimental | Not described Receives: Drug: AR-12286 0.5% ophthalmic solution |
| AR-12286 0.25% Ophthalmic Solution | Experimental | Not described Receives: Drug: AR-12286 0.25% Ophthalmic solution |
| Latanoprost 0.005% ophthalmic solution | Experimental | Not described Receives: Drug: Latanoprost ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint will be the mean intraocular pressure (IOP) across subjects within treatment group on each day at each post-treatment timepoint
Measured: 28 days of dosing
Secondary outcomes (1)
Mean change from diurnally adjusted baseline IOP at each timepoint
Measured: 28 days of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerie Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas van Haarlem, MD, Study director, Aerie Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060579
- Sponsor's protocol ID
- AR-12286-CS202
- Status last verified
- Apr 2014
- First submitted
- 30 Jan 2010
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-masked, Randomized, Active-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients With Elevated Intraocular Pressure
- ClinicalTrials.gov ID
- NCT01060579
- Acronym / sponsor ID
- AR-12286-CS202
- Conditions
- Glaucoma
- Keywords
- Glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 2 Feb 2010 (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 28 day study of the safety and efficacy of two concentrations of topical AR-12286 in treating ocular hypertension and open-angle glaucoma compared to latanoprost. Hypothesis: The ocular hypotensive efficacy of each dose of AR-12286 ophthalmic solution will not be different from that of an active control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AR-12286 0.5% ophthalmic solution | Experimental | Drug: AR-12286 0.5% ophthalmic solution |
| AR-12286 0.25% Ophthalmic Solution | Experimental | Drug: AR-12286 0.25% Ophthalmic solution |
| Latanoprost 0.005% ophthalmic solution | Experimental | Drug: Latanoprost ophthalmic solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or greater.
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) and currently being treated with ocular hypotensive medication.
- Unmedicated (post-washout) IOP ≥ 22 mm Hg at 2 eligibility visits (07:00-09:00 hr), 2-7 days apart.
- Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
- Has used a commercially available IOP-lowering medication in one or both eyes for at least 30 days over the 90 days prior to the screening visit.
Key exclusion criteria (19 listed)
- Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure. Note: Previous laser peripheral iridotomy is acceptable.
- Intraocular pressure > 36 mm Hg
- 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.).
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 0.5% ophthalmic solutionq.d. PM | Drug | AR-12286 0.5% ophthalmic solution |
| AR-12286 0.25% Ophthalmic solutionq.d. PM | Drug | AR-12286 0.25% Ophthalmic Solution |
| Latanoprost ophthalmic solutionAlso: Xalatan(R)q.d. PM | Drug | Latanoprost 0.005% ophthalmic solution |
Primary outcome
The primary efficacy endpoint will be the mean intraocular pressure (IOP) across subjects within treatment group on each day at each post-treatment timepoint
Time frame: 28 days of dosing
1 secondary outcome
Mean change from diurnally adjusted baseline IOP at each timepoint
Time frame: 28 days of dosing
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 8 May 2014.
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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.
Thomas van Haarlem, MD study director
Aerie Pharmaceuticals, Inc.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AR-12286 0.5% ophthalmic solution, AR-12286 0.25% Ophthalmic solution and Latanoprost ophthalmic solution in people with Glaucoma, run by Aerie Pharmaceuticals at 18 sites in United States.
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 6 inclusion and 19 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 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The primary efficacy endpoint will be the mean intraocular pressure (IOP) across subjects within treatment group on each day at each post-treatment timepoint (time frame: 28 days of dosing). 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 8 May 2014.