GlaucomaPhase 2NCT01474135
AR-12286 Fixed Dose Combination to Lower Elevated Intraocular Pressure
A Phase 2 study testing 0.25% AR-12286 / 0.004% travoprost, 0.5% AR-12286, 0.004% travoprost and 0.004% Travoprost in people with Glaucoma and Ocular Hypertension, run by Aerie Pharmaceuticals at 9 sites in United States.
Trial summary
This is a double-masked, randomized, controlled study assessing the safety and ocular hypotensive efficacy of two AR 12286/travoprost fixed-dose combination products compared to Travatan® Z in patients with elevated intraocular pressure Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- 0.25% AR-12286 / 0.004% travoprost, 0.5% AR-12286, 0.004% travoprost and 0.004% Travoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 9 sitesUnited States
- Study dates
- Dec 2011to Apr 2012
- 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 120 years
- 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) IOP ≥ 24 mm Hg at 2 eligibility visits (08:00 hr), 2-7 days apart. At second eligibility visit, IOP >22 mmHg at 10:00, 12:00 and 16:00 hrs.
- 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 (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 travoprost, 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 20Show 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 nonclinical 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.
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Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Abrams Eye Center
Cleveland, Ohio, 44115
Cataract & Glaucoma Center
El Paso, Texas, 79902
United Medical Research Institute
Inglewood, California, 90301
Aesthetic Eye Care Institute
Newport Beach, California, 92657
Bacharach practice
Petaluma, California, 94954
Centre For Health Care
Poway, California, 92064
Rochester Ophthalmology Group
Rochester, New York, 14618
Glaucoma Consultants of the Capital Region
Slingerlands, New York, 12159
Comprehensive Eye Care
St Louis, Missouri, 63090
About this study
Official title: A Double-masked, Randomized, Controlled Study Assessing the Safety and Ocular Hypotensive Efficacy of Two AR 12286/Travoprost Fixed-dose Combination Products Compared to Travatan® Z in Patients With Elevated Intraocular Pressure
This is a double-masked, randomized, controlled study assessing the safety and ocular hypotensive efficacy of two AR 12286/travoprost fixed-dose combination products compared to Travatan® Z in patients with elevated intraocular pressure
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- 0.25% AR-12286 / 0.004% travoprost, 0.5% AR-12286, 0.004% travoprost, 0.004% Travoprost
- Keywords
- Glaucoma, Ocular Hypertension
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25% AR-12286 / 0.004% travoprostDrug
0.5% AR-12286, 0.004% travoprostDrug
0.004% TravoprostDrug
| Study group | Role | What they receive |
|---|---|---|
| 0.25% AR-12286/ 0.004% travoprost | Experimental | Fixed dose combination of 0.25% AR-12286 and 0.004% travoprost Receives: Drug: 0.25% AR-12286 / 0.004% travoprost |
| 0.5% AR-12286/ 0.004% travoprost | Experimental | Fixed dose combination of 0.5% AR-12286/ 0.004% travoprost Receives: Drug: 0.5% AR-12286, 0.004% travoprost |
| 0.004%Travoprost | Active comparator | Travatan(R) Z(travoprost ophthalmic solution) Receives: Drug: 0.004% Travoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean IOP across subjects within treatment group on Days 1 and 7 at each post-treatment timepoint.
Intraocular pressure
Measured: 7 days
Secondary outcomes (1)
Ocular and systemic safety
Ophthalmic examination and adverse event reports
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2012
- Study completionApr 2012
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerie Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474135
- Sponsor's protocol ID
- PG286-CS201
- Status last verified
- Sep 2016
- First submitted
- 11 Nov 2011
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-masked, Randomized, Controlled Study Assessing the Safety and Ocular Hypotensive Efficacy of Two AR 12286/Travoprost Fixed-dose Combination Products Compared to Travatan® Z in Patients With Elevated Intraocular Pressure
- ClinicalTrials.gov ID
- NCT01474135
- Acronym / sponsor ID
- PG286-CS201
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Ocular Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 18 Nov 2011 (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.
This is a double-masked, randomized, controlled study assessing the safety and ocular hypotensive efficacy of two AR 12286/travoprost fixed-dose combination products compared to Travatan® Z in patients with elevated intraocular pressure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.25% AR-12286/ 0.004% travoprost | Experimental | Drug: 0.25% AR-12286 / 0.004% travoprostFixed dose combination of 0.25% AR-12286 and 0.004% travoprost |
| 0.5% AR-12286/ 0.004% travoprost | Experimental | Drug: 0.5% AR-12286, 0.004% travoprostFixed dose combination of 0.5% AR-12286/ 0.004% travoprost |
| 0.004%Travoprost | Active comparator | Drug: 0.004% TravoprostTravatan(R) Z(travoprost ophthalmic solution) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or greater.
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
- Unmedicated (post-washout) IOP ≥ 24 mm Hg at 2 eligibility visits (08:00 hr), 2-7 days apart. At second eligibility visit, IOP >22 mmHg at 10:00, 12:00 and 16:00 hrs.
- 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 (20 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 travoprost, 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 |
|---|---|---|
| 0.25% AR-12286 / 0.004% travoprost | Drug | 0.25% AR-12286/ 0.004% travoprost |
| 0.5% AR-12286, 0.004% travoprost | Drug | 0.5% AR-12286/ 0.004% travoprost |
| 0.004% Travoprost | Drug | 0.004%Travoprost |
Primary outcome
Mean IOP across subjects within treatment group on Days 1 and 7 at each post-treatment timepoint.
Time frame: 7 days
Intraocular pressure
1 secondary outcome
Ocular and systemic safety
Time frame: 7 days
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 23 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 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 0.25% AR-12286 / 0.004% travoprost, 0.5% AR-12286, 0.004% travoprost and 0.004% Travoprost in people with Glaucoma and Ocular Hypertension, run by Aerie Pharmaceuticals at 9 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 5 inclusion and 20 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 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Mean IOP across subjects within treatment group on Days 1 and 7 at each post-treatment timepoint. (time frame: 7 days). 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 23 Sep 2016.