Open-angle GlaucomaPhase 3NCT02558374
Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
A Phase 3 study testing AR-13324 Ophthalmic Solution 0.02% and Timolol Maleate Ophthalmic Solution 0.5% BID in people with Open-angle Glaucoma and Ocular Hypertension, run by Aerie Pharmaceuticals at 1 site in United States.
Trial summary
To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-angle Glaucoma, Ocular Hypertension
- What is being tested?
- AR-13324 Ophthalmic Solution 0.02% and Timolol Maleate Ophthalmic Solution 0.5% BID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 708 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Diagnosis of open angle glaucoma or ocular hypertension in both eyes
- Post-washout intraocular pressure >20mmHg and <30mmHg in 1 or both eyes at 2 qualification visits
- Corrected visual acuity equivalent to 20/200
- Able to give informed consent and follow study instructions
Who cannot join
- Clinically significant ocular disease
- Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
- Unmedicated intraocular pressure ≥30mmHg
- Use of more than 2 ocular hypotensive medications within 30 days of screening
- Known hypersensitivity to any component of the formulation
- Previous glaucoma surgery or refractive surgery
Show all 18Show fewer
- Ocular trauma within 6 months prior to screening
- Any ocular surgery or non-refractive laser treatment within 3 months prior to screening
- Recent or current ocular infection or inflammation in either eye
- Used ocular medication in either eye of any kind within 30 days of screening
- Mean central corneal thickness >620µm at screening
- Any abnormality preventing reliable applanation tonometry of either eye
- Clinically significant abnormalities in lab tests at screening
- Known hypersensitivity or contraindication to beta-adrenoceptor antagonists
- Clinically significant systemic disease
- Participation in any investigational study within 60 days prior to screening
- Used any systemic medication that could have a substantial effect in intraocular pressure within 30 days prior to screening
- Women who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-masked, Randomized, Multi-center, Active-controlled, Parallel Group, 6-month Study With a 3-month Interim Analysis Assessing the Ocular Hypotensive Efficacy and Safety of AR-13324 Ophthalmic Solution, 0.02% QD Compared to Timolol Maleate Ophthalmic Solution, 0.5% BID in Patients With Elevated Intraocular Pressure
To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution.
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Being tested
- AR-13324 Ophthalmic Solution 0.02%, Timolol Maleate Ophthalmic Solution 0.5% BID, Placebo
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
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
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) \& 1 drop placebo in the morning (AM) in both eyes (OU) Receives: Drug: AR-13324 Ophthalmic Solution 0.02%; Other: Placebo |
| Timolol Maleate Ophthalmic Solution 0.5% BID | Active comparator | 1 drop twice daily (BID) in the morning (AM) \& 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.
IOP (Intraocular Pressure)
The primary efficacy outcome is mean IOP
Measured: 3 months
Secondary outcomes (1)
Extent of Exposure
Exposure to study medication in days for all treatment groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startSep 2015
- 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 Open-angle 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 708 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
- NCT02558374
- Sponsor's protocol ID
- AR-13324-CS304
- Status last verified
- Jan 2018
- First submitted
- 16 Sep 2015
- Last updated
- 6 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
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 Group, 6-month Study With a 3-month Interim Analysis Assessing the Ocular Hypotensive Efficacy and Safety of AR-13324 Ophthalmic Solution, 0.02% QD Compared to Timolol Maleate Ophthalmic Solution, 0.5% BID in Patients With Elevated Intraocular Pressure
- ClinicalTrials.gov ID
- NCT02558374
- Acronym / sponsor ID
- AR-13324-CS304
- Conditions
- Open-angle Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 708 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Sep 2015 (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.
To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic Solution compared to Timolol Maleate Ophthalmic Solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| 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) \& 1 drop placebo in the morning (AM) in both eyes (OU) |
| Timolol Maleate Ophthalmic Solution 0.5% BID | Active comparator | Drug: Timolol Maleate Ophthalmic Solution 0.5% BID1 drop twice daily (BID) in the morning (AM) \& evening (PM) in both eyes (OU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Diagnosis of open angle glaucoma or ocular hypertension in both eyes
- Post-washout intraocular pressure >20mmHg and <30mmHg in 1 or both eyes at 2 qualification visits
- Corrected visual acuity equivalent to 20/200
- Able to give informed consent and follow study instructions
Key exclusion criteria (18 listed)
- Clinically significant ocular disease
- Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
- Unmedicated intraocular pressure ≥30mmHg
- Use of more than 2 ocular hypotensive medications within 30 days of screening
- Known hypersensitivity to any component of the formulation
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 |
| 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
IOP (Intraocular Pressure)
Time frame: 3 months
The primary efficacy outcome is mean IOP
1 secondary outcome
Extent of Exposure
Time frame: 6 months
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, Inc
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% and Timolol Maleate Ophthalmic Solution 0.5% BID in people with Open-angle Glaucoma and Ocular Hypertension, 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 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 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?
IOP (Intraocular Pressure) (time frame: 3 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.