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Trial record 16 of 19 for:    netarsudil

A Controlled Study of the Aqueous Humor Dynamics of AR-13324 Ophthalmic Solution in Healthy Adult Volunteers

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ClinicalTrials.gov Identifier: NCT02406287
Recruitment Status : Completed
First Posted : April 2, 2015
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Brief Summary:
To evaluate the effect of netarsudil (AR-13324) ophthalmic solution on aqueous humor dynamics relative to its placebo.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Netarsudil (AR-13324) Ophthalmic Solution Drug: Netarsudil (AR-13324) Ophthalmic Solution Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Netarsudil

Arm Intervention/treatment
Experimental: Active
Netarsudil (AR-13324) Ophthalmic Solution
Drug: Netarsudil (AR-13324) Ophthalmic Solution
Topical ophthalmic solution

Placebo Comparator: Placebo
Netarsudil (AR-13324) Ophthalmic Solution Placebo
Drug: Netarsudil (AR-13324) Ophthalmic Solution Placebo
Ophthalmic solution once a day




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. Safety - Number of participants with adverse events [ Time Frame: Day 1 compared to Day 8 ]
    Number of participants with adverse events as a measure of safety and tolerability



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adult male or female subjects at least 18 years of age.
  2. Local area resident, existing patient or employee of Mayo Clinic.
  3. Medically healthy subjects with clinically insignificant screening results.
  4. Subjects with two normal (non-diseased) eyes.
  5. Intraocular pressure between 14 and 21 mm Hg (inclusive) in each eye at screening.
  6. Best-corrected visual acuity in each eye of +0.4 (20/50) or better.
  7. Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria:

  1. Chronic or acute ophthalmic disease including glaucoma, macular degeneration, uveitis clinically significant cataract.
  2. Known hypersensitivity to any component of the formulation or to topical anesthetics.
  3. Previous intraocular surgery, retina laser procedures or refractive surgery.
  4. Myopia greater than -4.00 D spherical equivalent.
  5. Hyperopia greater than +2.00 D spherical equivalent.
  6. Ocular trauma within the past six months.
  7. Evidence of ocular infection, inflammation, cystoid macular edema, clinically significant blepharitis or conjunctivitis, or a history of herpes simplex keratitis.
  8. Ocular medication of any kind within 30 days of screening.
  9. Any abnormality preventing reliable applanation tonometry of either eye.
  10. Central corneal thickness less than 500 μm or greater than 600 μm.
  11. Cannot demonstrate proper delivery of the eye drop.
  12. Clinically significant systemic disease which might interfere with the study.
  13. Participation in any investigational study within the past 30 days prior to screening.
  14. Use of systemic medication that could have a substantial effect on intraocular pressure within 30 days prior to screening, or anticipated during the study.
  15. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406287


Locations
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United States, New Jersey
Aerie Pharmaceutical
Bedminster, New Jersey, United States, 07921
Sponsors and Collaborators
Aerie Pharmaceuticals
Investigators
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Study Director: Nancy Ramirez Aerie Pharmaceuticals

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Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02406287     History of Changes
Other Study ID Numbers: AR-13324-CS102
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
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Pharmaceutical Solutions
Ophthalmic Solutions