Ocular HypertensionPhase 3NCT02246764
Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
A Phase 3 study testing AR-13324 Ophthalmic Solution 0.02%, AR-13324 Ophthalmic Solution 0.02% BID and Timolol maleate Ophthalmic Solution 0.5% BID in people with Ocular Hypertension and Glaucoma, run by Aerie Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the ocular and systemic safety of Netarsudil (AR-13324) Ophthalmic Solution, 0.02% q.d. and b.i.d. for 12 months compared to the active comparator Timolol Maleate Ophthalmic Solution, 0.5%. Read more about this study
- Who is it for?
- Ages 19 to 99 years
- Conditions the study is for
- Ocular Hypertension, Glaucoma
- What is being tested?
- AR-13324 Ophthalmic Solution 0.02%, AR-13324 Ophthalmic Solution 0.02% BID and Timolol maleate Ophthalmic Solution 0.5% BID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2016
- Phase
- Phase 3
- 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 19 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 years of age or greater.
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
- Unmedicated (post-washout) IOP (Intraocular Pressure) >20 mm Hg and < 27 mm Hg in the study eye at 2 qualification visits (08:00 hr), 2-7 days apart. At second qualification visit, IOP > 17 mm Hg and < 27 mm Hg at 10:00 and 16:00 hrs (in the same eye).
- Corrected visual acuity in each eye +1.0 logMAR 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
- Ophthalmic:
- Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
- Intraocular pressure ≥27 mm Hg (unmedicated) in both eyes (individuals who are excluded for this criterion are not allowed to attempt requalification), or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combinations count as two medications.
- Known hypersensitivity to any component of the formulations to be used (benzalkonium chloride, etc.), to topical anesthetics or β-adrenoceptor antagonists.
- Previous glaucoma intraocular surgery or glaucoma laser procedures in either eye.
- Refractive surgery in either eye (e.g., radial keratotomy, PRK (photorefractive keratectomy), LASIK (laser eye surgery), corneal cross-linking, etc.).
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- Ocular trauma in either eye within the six months prior to screening, or ocular surgery or non-refractive laser treatment within the three months prior to screening.
- Recent or current evidence of ocular infection or inflammation in either eye. Current evidence of clinically significant blepharitis, conjunctivitis, or a history of herpes simplex or zoster keratitis at screening in either eye.
- Ocular medication in either eye of any kind within 30 days of screening, 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 screening) or c) lubricating drops for dry eye (which may be used throughout the study).
- Clinically significant ocular disease in either eye (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., cup-disc ratio > 0.8, severe visual field defect).
- Central corneal thickness in either eye greater than 600 µm at screening.
- Any abnormality in either eye preventing reliable applanation tonometry of either eye.
- Systemic:
- Clinically relevant abnormalities (as determined by the investigator) in laboratory tests at screening which may impact the study.
- Known hypersensitivity or contraindication to beta-adrenoceptor antagonists (e.g., chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure or heart rate; second or third degree heart block or congestive heart failure; severe diabetes).
- 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 30 days prior to screening.
- Changes of systemic medication that could have an effect on IOP within 30 days 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. 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
1 site in 1 country.
About this study
Official title: A Double-masked, Randomized, Multi-center, Active-controlled, Parallel, 12-month Study Assessing the Safety of AR-13324 Ophthalmic Solution, 0.02% QD & BID Compared to Timolol Maleate Ophthalmic Solution, 0.5% BID in Patients With Elevated Intraocular Pressure
The purpose of this study is to evaluate the ocular and systemic safety of Netarsudil (AR-13324) Ophthalmic Solution, 0.02% q.d. and b.i.d. for 12 months compared to the active comparator Timolol Maleate Ophthalmic Solution, 0.5%.
- Conditions
- Ocular Hypertension, Glaucoma
- Being tested
- AR-13324 Ophthalmic Solution 0.02%, AR-13324 Ophthalmic Solution 0.02% BID, Timolol maleate Ophthalmic Solution 0.5% BID, Placebo
- Keywords
- Ocular hypertension., Glaucoma
- 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-13324 Ophthalmic Solution 0.02%Drug
Also called Netarsudil
1 drop once daily (QD), PM, OU
AR-13324 Ophthalmic Solution 0.02% BIDDrug
Also called Netarsudil
1 drop BID, AM/PM, OU
Timolol maleate Ophthalmic Solution 0.5% BIDDrug
1 drop BID, AM/PM, OU
PlaceboOther
1 drop QD, AM, OU
| Study group | Role | What they receive |
|---|---|---|
| AR-13324 Ophthalmic Solution 0.02% & placebo | Experimental | 1 drop AR-13324 in the evening (PM) and 1 drop placebo in the morning (AM) in both eyes (OU) Receives: Drug: AR-13324 Ophthalmic Solution 0.02%; Other: Placebo |
| AR-13324 Ophthalmic Solution 0.02% BID | Experimental | 1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) Receives: Drug: AR-13324 Ophthalmic Solution 0.02% BID |
| Timolol maleate Ophthalmic Solution 0.5% BID | Active comparator | 1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) Receives: Drug: Timolol maleate Ophthalmic Solution 0.5% BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of Exposure
Exposure to study medication in days for all treatment groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2016
- Study completionDec 2016
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246764
- Sponsor's protocol ID
- AR-13324-CS303
- Status last verified
- Jan 2018
- First submitted
- 16 Sep 2014
- Last updated
- 6 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 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-masked, Randomized, Multi-center, Active-controlled, Parallel, 12-month Study Assessing the Safety of AR-13324 Ophthalmic Solution, 0.02% QD & BID Compared to Timolol Maleate Ophthalmic Solution, 0.5% BID in Patients With Elevated Intraocular Pressure
- ClinicalTrials.gov ID
- NCT02246764
- Acronym / sponsor ID
- AR-13324-CS303
- Conditions
- Ocular Hypertension, Glaucoma
- Keywords
- Ocular hypertension., Glaucoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Sep 2014 (estimated)
- Results
- Posted 6 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the ocular and systemic safety of Netarsudil (AR-13324) Ophthalmic Solution, 0.02% q.d. and b.i.d. for 12 months compared to the active comparator Timolol Maleate Ophthalmic Solution, 0.5%.
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 0.02% & placebo | Experimental | Drug: AR-13324 Ophthalmic Solution 0.02%, Other: Placebo1 drop AR-13324 in the evening (PM) and 1 drop placebo in the morning (AM) in both eyes (OU) |
| AR-13324 Ophthalmic Solution 0.02% BID | Experimental | Drug: AR-13324 Ophthalmic Solution 0.02% BID1 drop AR-13324 twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) |
| Timolol maleate Ophthalmic Solution 0.5% BID | Active comparator | Drug: Timolol maleate Ophthalmic Solution 0.5% BID1 drop Timolol maleate twice daily (BID) in the morning (AM) and evening (PM) in both eyes (OU) |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 19 years of age or greater.
- Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
- Unmedicated (post-washout) IOP (Intraocular Pressure) >20 mm Hg and < 27 mm Hg in the study eye at 2 qualification visits (08:00 hr), 2-7 days apart. At second qualification visit, IOP > 17 mm Hg and < 27 mm Hg at 10:00 and 16:00 hrs (in the same eye).
- Corrected visual acuity in each eye +1.0 logMAR 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 (19 listed)
- Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
- Intraocular pressure ≥27 mm Hg (unmedicated) in both eyes (individuals who are excluded for this criterion are not allowed to attempt requalification), or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combinations count as two medications.
- Known hypersensitivity to any component of the formulations to be used (benzalkonium chloride, etc.), to topical anesthetics or β-adrenoceptor antagonists.
- Previous glaucoma intraocular surgery or glaucoma laser procedures in either eye.
- Refractive surgery in either eye (e.g., radial keratotomy, PRK (photorefractive keratectomy), LASIK (laser eye surgery), corneal cross-linking, 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 |
|---|---|---|
| AR-13324 Ophthalmic Solution 0.02%Also: Netarsudil1 drop once daily (QD), PM, OU | Drug | AR-13324 Ophthalmic Solution 0.02% & placebo |
| AR-13324 Ophthalmic Solution 0.02% BIDAlso: Netarsudil1 drop BID, AM/PM, OU | Drug | AR-13324 Ophthalmic Solution 0.02% BID |
| Timolol maleate Ophthalmic Solution 0.5% BID1 drop BID, AM/PM, OU | Drug | Timolol maleate Ophthalmic Solution 0.5% BID |
| Placebo1 drop QD, AM, OU | Other | AR-13324 Ophthalmic Solution 0.02% & placebo |
Primary outcome
Extent of Exposure
Time frame: 12 months
Exposure to study medication in days for all treatment groups
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AR-13324 Ophthalmic Solution 0.02%, AR-13324 Ophthalmic Solution 0.02% BID and Timolol maleate Ophthalmic Solution 0.5% BID in people with Ocular Hypertension and Glaucoma, run by Aerie Pharmaceuticals at 1 site 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 6 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 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 6 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?
Extent of Exposure (time frame: 12 months). 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 6 Apr 2018.