Ocular HypertensionPhase 2NCT01731002
Study Comparing the Safety and Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure
A Phase 2 study testing AR-13324 Ophthalmic Solution 0.01%, AR-13324 Ophthalmic Solution 0.02% and Latanoprost ophthalmic solution 0.005% in people with Ocular Hypertension and Open Angle Glaucoma, run by Aerie Pharmaceuticals at 22 sites in United States.
Trial summary
Double-masked, randomized, multi-center, dose-response, active-controlled parallel-comparison of AR-13324 to latanoprost 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 Latanoprost ophthalmic solution 0.005%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 22 sitesUnited States
- Study dates
- Nov 2012to May 2013
- 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.
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
- Unmedicated (post-washout) Intraocular Pressure (IOP) ≥ 24 mm Hg at 2 eligibility visits (08:00 hr), 2-7 days a part, and ≥ 22 mm Hg at 10:00 and 16:00 hrs at the second qualification visit. If only one eye meets the IOP criteria it must be the same eye that met the criteria at all the qualification timepoints.
- 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
- Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
- IOP > 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, e.g., laser trabeculoplasty).
- Refractive surgery in study eye(s) (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser eye surgery (LASIK), etc.).
Show all 19Show fewer
- Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months prior to screening.
- Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at screening (Visit 0), or a history of herpes simplex keratitis
- Ocular medication of any kind within 30 days of Visit 0, 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 0) or c) lubricating drops for dry eye (which may be used throughout the study).
- Clinically significant ocular disease (e.g. 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 µm.
- Any abnormality preventing reliable applanation tonometry of either eye.
- Systemic:
- Clinically significant abnormalities (as determined by the treating physician) in laboratory tests at screening.
- Known hypersensitivity or contraindication to latanoprost.
- Clinically significant systemic disease (e.g., myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
- Participation in any investigational study within 30 days prior to screening.
- 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 the current status of the 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
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Kenneth Sall, M.D.
Artesia, California, 90701
Texan Eye
Austin, Texas, 78731
Alan L Robin, M.D.
Baltimore, Maryland, 21209
Charlotte Eye Ear Nose and Throat
Charlotte, North Carolina, 28210
Cataract & Glaucoma Center
El Paso, Texas, 79902
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, 21078
Michael E. Tepedino, M.D.
High Point, North Carolina, 27262
United Medical Research Institute
Inglewood, California, 90301
Taustine Eye Center
Louisville, Kentucky, 40217
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563
Clayton Eye Center
Morrow, Georgia, 30260
Aesthetic Eye Care Institute
Newport Beach, California, 92657
Virginia Eye Consultants
Norfolk, Virginia, 23502
North Bay Eye Associates
Petaluma, California, 94954
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Centre For Health Care
Poway, California, 92064
Rochester Ophthalmological Group
Rochester, New York, 14618
Coastal Research Associates, LLC
Roswell, Georgia, 30076
Great Lakes Eye Care
Saint Joseph, Michigan, 49085
Medical Center Ophth. Associates
San Antonio, Texas, 78731
Bradley Kwapiszeski, MD
Shawnee Mission, Kansas, 66204
The Eye Institute
Tulsa, Oklahoma, 74104
About this study
Official title: A Phase 2, Double-masked, Randomized, Multi-center, Active-controlled, Dose-response Parallel-group Study Comparing the Safety and Ocular Hypotensive Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure
Double-masked, randomized, multi-center, dose-response, active-controlled parallel-comparison of AR-13324 to latanoprost
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Being tested
- AR-13324 Ophthalmic Solution 0.01%, AR-13324 Ophthalmic Solution 0.02%, Latanoprost ophthalmic solution 0.005%
- Keywords
- Glaucoma
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle, Glaucoma
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 evening (PM) for 28 days
AR-13324 Ophthalmic Solution 0.02%Drug
Also called Netarsudil
Administered to study eye, QD in the PM for 28 days
Latanoprost ophthalmic solution 0.005%Drug
Also called Latanoprost
Administered to study eye, QD in the PM for 28 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% |
| Latanoprost Ophthalmic Solution 0.005% | Active comparator | 1 drop to study eye once daily Receives: Drug: Latanoprost ophthalmic solution 0.005% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure (IOP)
The primary efficacy endpoint was the mean IOP across subjects within treatment group on each day at each post-treatment timepoint. IOP was measured at 0800, 1000, and 1600 hours on days 0, 14, and 28. IOP was also measured at 0800 hours on Day 7 and follow-up days 29 and 30.
Measured: Study treatment was administered for 28 days
Secondary outcomes (1)
Extent of Exposure
Exposure to study medication in days for all treatment groups.
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 posted21 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionMay 2013
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
- 224 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
- NCT01731002
- Sponsor's protocol ID
- AR-13324-CS202
- Status last verified
- Jun 2016
- First submitted
- 15 Nov 2012
- Last updated
- 17 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 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-masked, Randomized, Multi-center, Active-controlled, Dose-response Parallel-group Study Comparing the Safety and Ocular Hypotensive Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure
- ClinicalTrials.gov ID
- NCT01731002
- Acronym / sponsor ID
- AR-13324-CS202
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Keywords
- Glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Posted 17 Apr 2018
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, dose-response, active-controlled parallel-comparison of AR-13324 to latanoprost
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| 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 |
| Latanoprost Ophthalmic Solution 0.005% | Active comparator | Drug: Latanoprost ophthalmic solution 0.005%1 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.
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
- Unmedicated (post-washout) Intraocular Pressure (IOP) ≥ 24 mm Hg at 2 eligibility visits (08:00 hr), 2-7 days a part, and ≥ 22 mm Hg at 10:00 and 16:00 hrs at the second qualification visit. If only one eye meets the IOP criteria it must be the same eye that met the criteria at all the qualification timepoints.
- 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 (19 listed)
- Ophthalmic
- Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
- IOP > 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, e.g., laser trabeculoplasty).
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 evening (PM) for 28 days | Drug | AR-13324 Ophthalmic Solution 0.01% |
| AR-13324 Ophthalmic Solution 0.02%Also: NetarsudilAdministered to study eye, QD in the PM for 28 days | Drug | AR-13324 Ophthalmic Solution 0.02% |
| Latanoprost ophthalmic solution 0.005%Also: LatanoprostAdministered to study eye, QD in the PM for 28 days | Drug | Latanoprost Ophthalmic Solution 0.005% |
Primary outcome
Intraocular Pressure (IOP)
Time frame: Study treatment was administered for 28 days
The primary efficacy endpoint was the mean IOP across subjects within treatment group on each day at each post-treatment timepoint. IOP was measured at 0800, 1000, and 1600 hours on days 0, 14, and 28. IOP was also measured at 0800 hours on Day 7 and follow-up days 29 and 30.
1 secondary outcome
Extent of Exposure
Time frame: 28 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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.
22 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 Latanoprost ophthalmic solution 0.005% in people with Ocular Hypertension and Open Angle Glaucoma, run by Aerie Pharmaceuticals at 22 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 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 17 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 22 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?
Yes. Results are posted in the registry (first posted 17 Apr 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 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 17 Apr 2018.