GlaucomaPhase 2NCT01302249
AR-12286 in Combination With Latanoprost
A Phase 2 study testing Latanoprost 0.005%, AR-12286 Ophthalmic Solution 0.5% and Timolol maleate ophthalmic solution 0.5% in people with Glaucoma and Ocular Hypertension, run by Aerie Pharmaceuticals at 15 sites in United States.
Trial summary
This is a double-masked, randomized, multi-center, active-controlled, crossover comparison of the addition of AR-12286 or timolol to latanoprost in the treatment of elevated intraocular pressure (IOP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- Latanoprost 0.005%, 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
- 66 participants
- Where
- 15 sitesUnited States
- Study dates
- Feb 2011to Dec 2011
- 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).
- Currently using prostaglandin analogue (monotherapy or combination therapy) O.U. ≥ 1 month at time of study entry (first qualification visit) in study eye(s).
- Qualification Visit 1 (Screening) IOP at 16:00 hrs: PG monotherapy patients: ≥ 18 mm Hg; Combination therapy patients: >= 16 mm Hg. Qualification Visit 2 (post latanoprost run-in) IOP ≥ 20 mm Hg at 08:00 hrs and 10:00 hrs, IOP ≥ 18 mm Hg at 16:00 hrs in study eye(s). (Note: combination therapy may include any combination of topical ocular hypotensive agents).
- 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
- In either eye:
- Previously randomized to treatment in a clinical study of AR-12286.
- Intraocular pressure > 36 mm Hg.
- History of acute angle-closure glaucoma, or closed or narrow angle upon gonioscopy
- Known hypersensitivity or contraindication to timolol maleate ophthalmic solution, or any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics, including history of conjunctival hyperemia with topical latanoprost of severity greater than 1 on a 0-3 scale.
- Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
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- Contact lens wear within 30 minutes of instillation of study medication.
- PG monotherapy patients: Ocular hypotensive medication (other than prostaglandin) within 4 weeks of Visit 0 (Study entry, first qualification visit). Combination therapy patients: Ocular hypotensive medication (other than prostaglandin and current additional agent) within 4 weeks of Visit 0 (Study entry, first qualification visit).
- Conjunctival hyperemia of grade 2+ or greater at Visit 1.
- Any other ocular medication within 4 weeks of Visit 1 with the exception of 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 treatment with only latanoprost for two periods of up to 4 weeks is not judged safe (e.g., advanced glaucomatous optic nerve head or visual field loss).
- Any abnormality preventing reliable applanation tonometry of either eye.
- In study eye(s):
- Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure. Note: Previous laser peripheral iridotomy is acceptable.
- Previous glaucoma intraocular surgery or laser procedures.
- Refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
- Central corneal thickness greater than 600 µ.
- Systemic:
- Known bronchial asthma (history or current), severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block or overt cardiac failure.
- Clinically significant abnormalities in laboratory tests at screening, recognizing that subjects are not fasting at the time of drawing blood.
- 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 that could have a substantial effect on IOP 4 weeks prior to screening, or anticipated during the study.
- Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Alan L Robin, M.D.
Baltimore, Maryland, 21209
Thomas K. Mundorf, M.D.
Charlotte, North Carolina, 28204
Charlotte Eye Ear Nose and Throat
Charlotte, North Carolina, 28210
Cataract & Glaucoma Center
El Paso, Texas, 79902
Taustine Eye Center
Louisville, Kentucky, 40217
David Silverstone, M.D.
New Haven, Connecticut, 06510
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Rochester Ophthalmology Group
Rochester, New York, 14618
Coastal Research Associates, LLC
Roswell, Georgia, 30076
Stacy R. Smith, M.D.
Salt Lake City, Utah, 84117
Heart of America Eye Care, P.A.
Shawnee Mission, Kansas, 66204
Glaucoma Consultants of the Capital Region
Slingerlands, New York, 12159
Comprehensive Eye Care
St Louis, Missouri, 63090
The Eye Institute
Tulsa, Oklahoma, 74104
About this study
Official title: A Phase 2, Double-masked, Randomized, Active-controlled, Crossover Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 or Timolol Added to Patients With Elevated Intraocular Pressure Currently Using Latanoprost
This is a double-masked, randomized, multi-center, active-controlled, crossover comparison of the addition of AR-12286 or timolol to latanoprost in the treatment of elevated intraocular pressure (IOP).
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Latanoprost 0.005%, AR-12286 Ophthalmic Solution 0.5%, Timolol maleate ophthalmic solution 0.5%
- Keywords
- Glaucoma, Intraocular pressure, 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.
Latanoprost 0.005%Drug
Also called Xalatan(R)
q.d.
AR-12286 Ophthalmic Solution 0.5%Drug
Timolol maleate ophthalmic solution 0.5%Drug
| Study group | Role | What they receive |
|---|---|---|
| AR-12286 | Experimental | AR-12286 Ophthalmic Solution 0.5% Receives: Drug: Latanoprost 0.005%; Drug: AR-12286 Ophthalmic Solution 0.5% |
| Timolol | Active comparator | Timolol maleate ophthalmic solution 0.5% Receives: Drug: Latanoprost 0.005%; Drug: Timolol maleate ophthalmic solution 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
The primary efficacy endpoint will be the mean IOP across subjects within treatment group at each study visit at each post-treatment timepoint.
Measured: 28 days
Secondary outcomes (2)
Ocular safety
Safety endpoints will be visual acuity, objective biomicroscopic and ophthalmoscopic examination, and subjective comfort as measured by adverse events in response to subject symptom queries.
Measured: 28 days
Systemic safety
Heart rate, and blood pressure.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2011
- Study completionDec 2011
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 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
- NCT01302249
- Sponsor's protocol ID
- AR-12286-CS203
- Status last verified
- Apr 2014
- First submitted
- 18 Feb 2011
- 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, Crossover Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 or Timolol Added to Patients With Elevated Intraocular Pressure Currently Using Latanoprost
- ClinicalTrials.gov ID
- NCT01302249
- Acronym / sponsor ID
- AR-12286-CS203
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Intraocular pressure, Ocular hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Feb 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, multi-center, active-controlled, crossover comparison of the addition of AR-12286 or timolol to latanoprost in the treatment of elevated intraocular pressure (IOP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AR-12286 | Experimental | Drug: Latanoprost 0.005%, Drug: AR-12286 Ophthalmic Solution 0.5%AR-12286 Ophthalmic Solution 0.5% |
| Timolol | Active comparator | Drug: Latanoprost 0.005%, Drug: Timolol maleate ophthalmic solution 0.5%Timolol maleate ophthalmic solution 0.5% |
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).
- Currently using prostaglandin analogue (monotherapy or combination therapy) O.U. ≥ 1 month at time of study entry (first qualification visit) in study eye(s).
- Qualification Visit 1 (Screening) IOP at 16:00 hrs: PG monotherapy patients: ≥ 18 mm Hg; Combination therapy patients: >= 16 mm Hg. Qualification Visit 2 (post latanoprost run-in) IOP ≥ 20 mm Hg at 08:00 hrs and 10:00 hrs, IOP ≥ 18 mm Hg at 16:00 hrs in study eye(s). (Note: combination therapy may include any combination of topical ocular hypotensive agents).
- Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
Key exclusion criteria (24 listed)
- Previously randomized to treatment in a clinical study of AR-12286.
- Intraocular pressure > 36 mm Hg.
- History of acute angle-closure glaucoma, or closed or narrow angle upon gonioscopy
- Known hypersensitivity or contraindication to timolol maleate ophthalmic solution, or any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics, including history of conjunctival hyperemia with topical latanoprost of severity greater than 1 on a 0-3 scale.
- Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
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 |
|---|---|---|
| Latanoprost 0.005%Also: Xalatan(R)q.d. | Drug | AR-12286, Timolol |
| AR-12286 Ophthalmic Solution 0.5% | Drug | AR-12286 |
| Timolol maleate ophthalmic solution 0.5% | Drug | Timolol |
Primary outcome
Intraocular pressure
Time frame: 28 days
The primary efficacy endpoint will be the mean IOP across subjects within treatment group at each study visit at each post-treatment timepoint.
2 secondary outcomes
Ocular safety
Time frame: 28 days
Systemic safety
Time frame: 28 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 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.
The record lists no contact. Use the official record to reach the sponsor.
15 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 Latanoprost 0.005%, AR-12286 Ophthalmic Solution 0.5% and Timolol maleate ophthalmic solution 0.5% in people with Glaucoma and Ocular Hypertension, run by Aerie Pharmaceuticals at 15 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 24 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 15 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?
Intraocular pressure (time frame: 28 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 8 May 2014.