Elevated Intraocular PressurePhase 2NCT00902200
A Study of AR-12286 in Patient With Elevated Intraocular Pressure (IOP)
A Phase 2 study testing AR-12286 in people with Elevated Intraocular Pressure, run by Aerie Pharmaceuticals at 8 sites in United States.
Trial summary
Double-masked, randomized, multi-center, placebo-controlled parallel-comparison of AR-12286. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elevated Intraocular Pressure
- What is being tested?
- AR-12286
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2009to Sep 2009
- 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). Unmedicated (post-washout, if required) IOP >= 24 mm Hg in one or both eyes at 08:00 hours, >= 21 mm Hg at 10:00, 12:00 and 16:00 hours on post-washout measurement (Visit 1).
- Corrected visual acuity in each eye +1.0 logMAR (logarithm mininum angle of resolution) or better by ETDRS (Early Treatment Diabetic Retinopathy Study) in each eye (equivalent to 20/200).
- Able and willing to give signed informed consent and follow study instructions.
Who cannot join
- Either eye
- Intraocular pressure > 36 mm Hg
- Known hypersensitivity to any component of the formulation or to topical anesthetics, (benzalkonium chloride, etc.)
- 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, or of herpes simplex keratitis, or clinically significant blepharitis or conjunctivitis at baseline (Visit 1)..
- Contact lens wear within 30 minutes of instillation of study medication.
Show all 21Show fewer
- Ocular medication of any kind within 30 days of Visit 2, 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 2) 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 microns.
- Any abnormality preventing reliable applanation tonometry.
- Study eye:
- Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure.
- Note: Previous laser peripheral iridotomy is acceptable.
- Previous glaucoma intraocular surgery or laser procedures in study eye(s).
- Refractive surgery in study eye(s) (e.g., radial keratotomy, PRK (photorefractive keratectomy), LASIK (Laser-Assisted in situ Keratomileusis), etc.).
- General/Systemic:
- Clinically significant abnormalities in laboratory tests at screening (See Appendix 1).
- 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 during the study 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
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Texan Eye
Austin, Texas, 78731
Hernando Eye Institute
Brooksville, Florida, 34613
Mundorf Practice
Charlotte, North Carolina, 28204
Taustine Eye Center
Louisville, Kentucky, 40217
Soilsh Practice
Pasadena, California, 91105
Bacharach practice
Petaluma, California, 94954
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
About this study
Official title: A Phase 2, Double-masked, Randomized, Placebo-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 Ophthalmic Solution 0.05%, 0.1% and 0.25% in Patients With Elevated Intraocular Pressure
Double-masked, randomized, multi-center, placebo-controlled parallel-comparison of AR-12286.
Read the detailed description
Subjects will be randomized to receive AR-12286 Ophthalmic Solution 0.05%, 0.1%, and 0.25% or its vehicle (one eye), q.d. (AM) x 7 days, then q.d. (PM) x 7 days, then b.i.d. x 7 days. The first dose will be administered in the clinic. Ocular safety and ocular hypotensive efficacy will be evaluated in the clinic throughout this period.
- Conditions
- Elevated Intraocular Pressure
- Being tested
- AR-12286, AR-12286 vehicle
- Keywords
- Glaucoma, Intraocular pressure
- Medical subject headings
- Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR-12286Drug
See arms
AR-12286 vehicleDrug
See arms
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | q.d. (AM) x 7 days, then q.d. (PM) x 7 days, then b.i.d. x 7 days. Receives: Drug: AR-12286 vehicle |
| AR-12286 0.05% | Experimental | q.d. (AM) x 7 days, then q.d. (PM) x 7 days, then b.i.d. x 7 days. Receives: Drug: AR-12286 |
| AR-12286 0.1% | Experimental | q.d. (AM) x 7 days, then q.d. (PM) x 7 days, then b.i.d. x 7 days. Receives: Drug: AR-12286 |
| AR-12286 0.25% | Experimental | q.d. (AM) x 7 days, then q.d. (PM) x 7 days, then b.i.d. x 7 days. Receives: Drug: AR-12286 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint will be mean diurnal IOP on each day at which diurnal IOP is measured at each timepoint.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elevated Intraocular PressureStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerie Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom van Haarlem, MD, Study director, Aerie Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902200
- Sponsor's protocol ID
- AR-12286-CS201
- Status last verified
- Mar 2014
- First submitted
- 13 May 2009
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Williams RD, Novack GD, van Haarlem T, Kopczynski C; AR-12286 Phase 2A Study Group. Ocular hypotensive effect of the Rho kinase inhibitor AR-12286 in patients with glaucoma and ocular hypertension. Am J Ophthalmol. 2011 Nov;152(5):834-41.e1. doi: 10.1016/j.ajo.2011.04.012. Epub 2011 Jul 27.
PubMed 21794845
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-masked, Randomized, Placebo-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 Ophthalmic Solution 0.05%, 0.1% and 0.25% in Patients With Elevated Intraocular Pressure
- ClinicalTrials.gov ID
- NCT00902200
- Acronym / sponsor ID
- AR-12286-CS201
- Conditions
- Elevated Intraocular Pressure
- Keywords
- Glaucoma, Intraocular pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 15 May 2009 (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.
Double-masked, randomized, multi-center, placebo-controlled parallel-comparison of AR-12286.
Detailed description
Subjects will be randomized to receive AR-12286 Ophthalmic Solution 0.05%, 0.1%, and 0.25% or its vehicle (one eye), q.d. (AM) x 7 days, then q.d. (PM) x 7 days, then b.i.d. x 7 days. The first dose will be administered in the clinic. Ocular safety and ocular hypotensive efficacy will be evaluated in the clinic throughout this period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Drug: AR-12286 vehicleq.d. (AM) x 7 days, then q.d. (PM) x 7 days, then b.i.d. x 7 days. |
| AR-12286 0.05% | Experimental | Drug: AR-12286q.d. (AM) x 7 days, then q.d. (PM) x 7 days, then b.i.d. x 7 days. |
| AR-12286 0.1% | Experimental | Drug: AR-12286q.d. (AM) x 7 days, then q.d. (PM) x 7 days, then b.i.d. x 7 days. |
| AR-12286 0.25% | Experimental | Drug: AR-12286q.d. (AM) x 7 days, then q.d. (PM) x 7 days, then b.i.d. x 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or greater.
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT). Unmedicated (post-washout, if required) IOP >= 24 mm Hg in one or both eyes at 08:00 hours, >= 21 mm Hg at 10:00, 12:00 and 16:00 hours on post-washout measurement (Visit 1).
- Corrected visual acuity in each eye +1.0 logMAR (logarithm mininum angle of resolution) or better by ETDRS (Early Treatment Diabetic Retinopathy Study) in each eye (equivalent to 20/200).
- Able and willing to give signed informed consent and follow study instructions.
Key exclusion criteria (21 listed)
- Either eye
- Intraocular pressure > 36 mm Hg
- Known hypersensitivity to any component of the formulation or to topical anesthetics, (benzalkonium chloride, etc.)
- 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, or of herpes simplex keratitis, or clinically significant blepharitis or conjunctivitis at baseline (Visit 1)..
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-12286See arms | Drug | AR-12286 0.05%, AR-12286 0.1%, AR-12286 0.25% |
| AR-12286 vehicleSee arms | Drug | Vehicle |
Primary outcome
The primary efficacy endpoint will be mean diurnal IOP on each day at which diurnal IOP is measured at each timepoint.
Time frame: 3 weeks
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 21 Apr 2014.
- Derived from this study: PubMed 21794845Williams RD, Novack GD, van Haarlem T, Kopczynski C; AR-12286 Phase 2A Study Group. Ocular hypotensive effect of the Rho kinase inhibitor AR-12286 in patients with glaucoma and ocular hypertension. Am J Ophthalmol. 2011 Nov;152(5):834-41.e1. doi: 10.1016/j.ajo.2011.04.012. Epub 2011 Jul 27.
Related trials for Elevated Intraocular Pressure
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
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.
Tom van Haarlem, MD study director
Aerie Pharmaceuticals, Inc.
8 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 in people with Elevated Intraocular Pressure, run by Aerie Pharmaceuticals at 8 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 4 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 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. Some participants in this study may receive a placebo. 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 mean diurnal IOP on each day at which diurnal IOP is measured at each timepoint. (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00902200, which also lists 1 linked publication.
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 21 Apr 2014.