Ocular HypertensionPhase 2NCT01528787
Study of AR-13324 in Patients With Elevated Intraocular Pressure
A Phase 2 study testing AR-13324 Ophthalmic Solution 0.01%, AR-13324 Ophthalmic Solution 0.02% and AR-13324 Ophthalmic Solution 0.04% in people with Ocular Hypertension and Open Angle Glaucoma, run by Aerie Pharmaceuticals at 11 sites in United States.
Trial summary
In this double-masked, vehicle-controlled, dose-response study, subjects will be randomized to receive AR-13324 Ophthalmic Solution 0.01%, 0.02%, and 0.04% or its vehicle (one eye), once daily (QD)in the morning (AM) for 7 days. The first dose and last dose will be administered in the clinic. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Ocular Hypertension, Open Angle Glaucoma
- What is being tested?
- AR-13324 Ophthalmic Solution 0.01%, AR-13324 Ophthalmic Solution 0.02% and AR-13324 Ophthalmic Solution 0.04%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 11 sitesUnited States
- Study dates
- Mar 2012to Jul 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or greater. 18 years of age or greater.
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
- Unmedicated (post-washout, p.r.n.) 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 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: 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.
- Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or history of herpes simplex keratitis.
- Contact lens wear within 30 minutes of instillation of study medication.
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- 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 (e.g., advanced glaucomatous optic nerve head or visual field loss).
- Any abnormality preventing reliable applanation tonometry in either eye. Study eye:
- Glaucoma: pseudoexfoliation or pigment dispersion component, history of acute angle-closure glaucoma, or closed or narrow angle upon gonioscopy. Note: Previous laser peripheral iridotomy is NOT acceptable.
- Previous glaucoma intraocular surgery or laser procedures such as argon laser trabeculoplasty (ALT), selective laser trabeculoplasty (SLT) or micropulse laser trabeculoplasty ( MLT), as well as refractive procedures such as radio keratotomy (RK), laser eye surgery (LASIK), photorefractive keratectomy (PRK), or collagen cross linking.
- Central corneal thickness greater than 600 μm.
- General/Systemic:
- 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 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
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Texan Eye
Austin, Texas, 78731
Robert Noecker, M.D., M.B.A.
Fairfield, Connecticut, 06824
Univ Eye Surgeons, Maryville Ctr.
Maryville, Tennessee, 37803
Aesthetic Eye Care Institute
Newport Beach, California, 92657
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Rochester Ophthalmology Group
Rochester, New York, 14618
Coastal Research Associates, LLC
Roswell, Georgia, 30076
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Heart of America Eye Care, P.A.
Shawnee Mission, Kansas, 66204
Comprehensive Eye Care
St Louis, Missouri, 63090
The Eye Institute
Tulsa, Oklahoma, 74104
About this study
Official title: A Phase 2, Double-masked, Randomized, Placebo-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of Three Doses of AR-13324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure
In this double-masked, vehicle-controlled, dose-response study, subjects will be randomized to receive AR-13324 Ophthalmic Solution 0.01%, 0.02%, and 0.04% or its vehicle (one eye), once daily (QD)in the morning (AM) for 7 days. The first dose and last dose will be administered in the clinic. Ocular safety and ocular hypotensive efficacy will be evaluated in the clinic throughout the study.
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Being tested
- AR-13324 Ophthalmic Solution 0.01%, AR-13324 Ophthalmic Solution 0.02%, AR-13324 Ophthalmic Solution 0.04%, AR-13324 Ophthalmic Solution Vehicle
- Keywords
- Intraocular pressure, visual field, Ocular hypertension or open angle glaucoma
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR-13324 Ophthalmic Solution 0.01%Drug
Administered to study eye, once daily (QD) in the morning (AM) for 7 days
AR-13324 Ophthalmic Solution 0.02%Drug
Also called Netarsudil
Administered to study eye, QD AM for 7 days
AR-13324 Ophthalmic Solution 0.04%Drug
Administered to study eye, QD AM for 7 days
AR-13324 Ophthalmic Solution VehicleOther
Administered to study eye, QD AM for 7 days
| Study group | Role | What they receive |
|---|---|---|
| AR-13324 Ophthalmic Solution 0.01% | Experimental | 1 drop to study eye once daily Receives: Drug: AR-13324 Ophthalmic Solution 0.01% |
| AR-13324 Ophthalmic Solution 0.02% | Experimental | 1 drop to study eye once daily Receives: Drug: AR-13324 Ophthalmic Solution 0.02% |
| AR-13324 Ophthalmic Solution 0.04% | Experimental | 1 drop to study eye once daily Receives: Drug: AR-13324 Ophthalmic Solution 0.04% |
| AR-13324 Ophthalmic Solution Vehicle | Placebo comparator | 1 drop to study eye once daily Receives: Other: AR-13324 Ophthalmic Solution Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
The primary efficacy outcome was the mean IOP across subjects within treatment group at each post-treatment timepoint of Day 8.
Instillation of study treatment commenced on Day 2 following measurement of IOP. IOP was measured at 0800, 1000, 1200 and 1600 hours on days 2 and 8. IOP was also measured at 0800 hours on Day 4.
Measured: Study treatment was administered for 7 days; starting on Day 2 and ending on Day 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerie Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theresa Heah, MD, Study director, Aerie Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528787
- Sponsor's protocol ID
- AR-13324-CS201
- Status last verified
- Jun 2016
- First submitted
- 5 Feb 2012
- Last updated
- 18 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. 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 Three Doses of AR-13324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure
- ClinicalTrials.gov ID
- NCT01528787
- Acronym / sponsor ID
- AR-13324-CS201
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Keywords
- Intraocular pressure, visual field, Ocular hypertension or open angle glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Posted 22 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this double-masked, vehicle-controlled, dose-response study, subjects will be randomized to receive AR-13324 Ophthalmic Solution 0.01%, 0.02%, and 0.04% or its vehicle (one eye), once daily (QD)in the morning (AM) for 7 days. The first dose and last dose will be administered in the clinic. Ocular safety and ocular hypotensive efficacy will be evaluated in the clinic throughout the study.
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 |
|---|---|---|
| AR-13324 Ophthalmic Solution 0.01% | Experimental | Drug: AR-13324 Ophthalmic Solution 0.01%1 drop to study eye once daily |
| AR-13324 Ophthalmic Solution 0.02% | Experimental | Drug: AR-13324 Ophthalmic Solution 0.02%1 drop to study eye once daily |
| AR-13324 Ophthalmic Solution 0.04% | Experimental | Drug: AR-13324 Ophthalmic Solution 0.04%1 drop to study eye once daily |
| AR-13324 Ophthalmic Solution Vehicle | Placebo comparator | Other: AR-13324 Ophthalmic Solution Vehicle1 drop to study eye once daily |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or greater. 18 years of age or greater.
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
- Unmedicated (post-washout, p.r.n.) 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 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 (18 listed)
- Ophthalmic: 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.
- Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or history of herpes simplex keratitis.
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-13324 Ophthalmic Solution 0.01%Administered to study eye, once daily (QD) in the morning (AM) for 7 days | Drug | AR-13324 Ophthalmic Solution 0.01% |
| AR-13324 Ophthalmic Solution 0.02%Also: NetarsudilAdministered to study eye, QD AM for 7 days | Drug | AR-13324 Ophthalmic Solution 0.02% |
| AR-13324 Ophthalmic Solution 0.04%Administered to study eye, QD AM for 7 days | Drug | AR-13324 Ophthalmic Solution 0.04% |
| AR-13324 Ophthalmic Solution VehicleAdministered to study eye, QD AM for 7 days | Other | AR-13324 Ophthalmic Solution Vehicle |
Primary outcome
Intraocular Pressure (IOP)
Time frame: Study treatment was administered for 7 days; starting on Day 2 and ending on Day 8.
The primary efficacy outcome was the mean IOP across subjects within treatment group at each post-treatment timepoint of Day 8. Instillation of study treatment commenced on Day 2 following measurement of IOP. IOP was measured at 0800, 1000, 1200 and 1600 hours on days 2 and 8. IOP was also measured at 0800 hours on Day 4.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Theresa Heah, MD study director
Aerie Pharmaceuticals, Inc.
11 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-13324 Ophthalmic Solution 0.01%, AR-13324 Ophthalmic Solution 0.02% and AR-13324 Ophthalmic Solution 0.04% in people with Ocular Hypertension and Open Angle Glaucoma, run by Aerie Pharmaceuticals at 11 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 18 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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Yes. Results are posted in the registry (first posted 22 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (IOP) (time frame: Study treatment was administered for 7 days; starting on Day 2 and ending on Day 8.). 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 18 Apr 2018.