Healthy SubjectsPhase 1NCT02406287
A Controlled Study of the Aqueous Humor Dynamics of AR-13324 Ophthalmic Solution in Healthy Adult Volunteers
A Phase 1 study testing Netarsudil (AR-13324) Ophthalmic Solution in people with Healthy Subjects, run by Aerie Pharmaceuticals at 1 site in United States.
Trial summary
To evaluate the effect of netarsudil (AR-13324) ophthalmic solution on aqueous humor dynamics relative to its placebo. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Netarsudil (AR-13324) Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Apr 2016
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult male or female subjects at least 18 years of age.
- Local area resident, existing patient or employee of Mayo Clinic.
- Medically healthy subjects with clinically insignificant screening results.
- Subjects with two normal (non-diseased) eyes.
- Intraocular pressure between 14 and 21 mm Hg (inclusive) in each eye at screening.
- Best-corrected visual acuity in each eye of +0.4 (20/50) or better.
- Able and willing to give signed informed consent and follow study instructions.
Who cannot join
- Chronic or acute ophthalmic disease including glaucoma, macular degeneration, uveitis clinically significant cataract.
- Known hypersensitivity to any component of the formulation or to topical anesthetics.
- Previous intraocular surgery, retina laser procedures or refractive surgery.
- Myopia greater than -4.00 D spherical equivalent.
- Hyperopia greater than +2.00 D spherical equivalent.
- Ocular trauma within the past six months.
Show all 15Show fewer
- Evidence of ocular infection, inflammation, cystoid macular edema, clinically significant blepharitis or conjunctivitis, or a history of herpes simplex keratitis.
- Ocular medication of any kind within 30 days of screening.
- Any abnormality preventing reliable applanation tonometry of either eye.
- Central corneal thickness less than 500 μm or greater than 600 μm.
- Cannot demonstrate proper delivery of the eye drop.
- Clinically significant systemic disease which might interfere with the study.
- Participation in any investigational study within the past 30 days prior to screening.
- Use of systemic medication that could have a substantial effect on intraocular pressure 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 physician-supervised form of birth control for at least the last 2 months.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effect of netarsudil (AR-13324) ophthalmic solution on aqueous humor dynamics relative to its placebo.
- Conditions
- Healthy Subjects
- Being tested
- Netarsudil (AR-13324) Ophthalmic Solution, Netarsudil (AR-13324) Ophthalmic Solution Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Netarsudil (AR-13324) Ophthalmic SolutionDrug
Topical ophthalmic solution
Netarsudil (AR-13324) Ophthalmic Solution PlaceboDrug
Ophthalmic solution once a day
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Netarsudil (AR-13324) Ophthalmic Solution Receives: Drug: Netarsudil (AR-13324) Ophthalmic Solution |
| Placebo | Placebo comparator | Netarsudil (AR-13324) Ophthalmic Solution Placebo Receives: Drug: Netarsudil (AR-13324) Ophthalmic Solution Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aqueous humor flow rate measured by non-contact fluorophotometer
Aqueous humor flow rate measured by non-contact fluorophotometer; change from baseline
Measured: Day 1 compared to Day 8
Change in outflow facility measured non-invasively by tonography
Outflow facility measured non-invasively by tonography; change from baseline
Measured: Day 1 compared to Day 8
Change in episcleral venous pressure measured non-invasively by slit-lamp exam
Episcleral venous pressure measured non-invasively by slit-lamp exam; change from baseline
Measured: Day 1 compared toDay 8
Change in visual acuity measured using eye chart
Visual acuity measured using eye chart; change from baseline
Measured: Day 1 compared to Day 8
Change in biomicroscopy exam using non-invasive slit-lamp to evaluate cornea, conjunctiva, and anterior chamber of eye
Biomicroscopy exam using non-invasive slit-lamp to evaluate cornea, conjunctiva, and anterior chamber of eye; change from baseline
Measured: Day 1 compared to Day 8
Secondary outcomes (1)
Safety - Number of participants with adverse events
Number of participants with adverse events as a measure of safety and tolerability
Measured: Day 1 compared to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerie Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nancy Ramirez, Study director, Aerie Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406287
- Sponsor's protocol ID
- AR-13324-CS102
- Status last verified
- Sep 2016
- First submitted
- 12 Mar 2015
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Study of the Aqueous Humor Dynamics of AR-13324 Ophthalmic Solution in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02406287
- Acronym / sponsor ID
- AR-13324-CS102
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 2 Apr 2015 (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.
To evaluate the effect of netarsudil (AR-13324) ophthalmic solution on aqueous humor dynamics relative to its placebo.
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 |
|---|---|---|
| Active | Experimental | Drug: Netarsudil (AR-13324) Ophthalmic SolutionNetarsudil (AR-13324) Ophthalmic Solution |
| Placebo | Placebo comparator | Drug: Netarsudil (AR-13324) Ophthalmic Solution PlaceboNetarsudil (AR-13324) Ophthalmic Solution Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy adult male or female subjects at least 18 years of age.
- Local area resident, existing patient or employee of Mayo Clinic.
- Medically healthy subjects with clinically insignificant screening results.
- Subjects with two normal (non-diseased) eyes.
- Intraocular pressure between 14 and 21 mm Hg (inclusive) in each eye at screening.
Key exclusion criteria (15 listed)
- Chronic or acute ophthalmic disease including glaucoma, macular degeneration, uveitis clinically significant cataract.
- Known hypersensitivity to any component of the formulation or to topical anesthetics.
- Previous intraocular surgery, retina laser procedures or refractive surgery.
- Myopia greater than -4.00 D spherical equivalent.
- Hyperopia greater than +2.00 D spherical equivalent.
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 |
|---|---|---|
| Netarsudil (AR-13324) Ophthalmic SolutionTopical ophthalmic solution | Drug | Active |
| Netarsudil (AR-13324) Ophthalmic Solution PlaceboOphthalmic solution once a day | Drug | Placebo |
Primary outcome
Change in aqueous humor flow rate measured by non-contact fluorophotometer
Time frame: Day 1 compared to Day 8
Aqueous humor flow rate measured by non-contact fluorophotometer; change from baseline
Change in outflow facility measured non-invasively by tonography
Time frame: Day 1 compared to Day 8
Outflow facility measured non-invasively by tonography; change from baseline
Change in episcleral venous pressure measured non-invasively by slit-lamp exam
Time frame: Day 1 compared toDay 8
Episcleral venous pressure measured non-invasively by slit-lamp exam; change from baseline
Change in visual acuity measured using eye chart
Time frame: Day 1 compared to Day 8
Visual acuity measured using eye chart; change from baseline
Change in biomicroscopy exam using non-invasive slit-lamp to evaluate cornea, conjunctiva, and anterior chamber of eye
Time frame: Day 1 compared to Day 8
Biomicroscopy exam using non-invasive slit-lamp to evaluate cornea, conjunctiva, and anterior chamber of eye; change from baseline
1 secondary outcome
Safety - Number of participants with adverse events
Time frame: Day 1 compared to Day 8
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 13 Sep 2016.
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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.
Nancy Ramirez 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 1 study testing Netarsudil (AR-13324) Ophthalmic Solution in people with Healthy Subjects, 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 7 inclusion and 15 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 13 Sep 2016. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change in aqueous humor flow rate measured by non-contact fluorophotometer (time frame: Day 1 compared to Day 8). The study lists 5 primary outcomes in all. 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 13 Sep 2016; AzTrials last refreshed its copy on 7 Nov 2026.