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Study Assessing Ocular and Systemic Safety of AR-13324 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01997879
Recruitment Status : Completed
First Posted : November 28, 2013
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Brief Summary:
The purpose of this study is to assess systemic safety and absorption of AR-13324 in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: AR-13324 Ophthalmic Solution, 0.02% Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study Assessing the Ocular and Systemic Safety and Systemic Absorption of AR-13324 Ophthalmic Solution, 0.02% in Healthy Volunteers
Study Start Date : November 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Netarsudil

Arm Intervention/treatment
Experimental: AR-13324 Ophthalmic Solution, 0.02%
Eyedrop
Drug: AR-13324 Ophthalmic Solution, 0.02%
Eyedrop




Primary Outcome Measures :
  1. Pharmacokinetic Assessment [ Time Frame: 8 Days ]
    Blood samples obtained to evaluate the systemic exposure (Area Under the Curve (AUC), Maximum Concentration, Time and half-life (Cmax, tmax and t ½)) to ocularly instilled AR-13324 and its metabolites as appropriate.



Information from the National Library of Medicine

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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:

  • Healthy adult male or female subjects at least 18 years of age.
  • Within 25% of their ideal weights.
  • Medically healthy subjects with clinically insignificant screening results (laboratory profiles, medical histories, ECGs, physical exam) as determined by the Investigator.
  • Non-tobacco/nicotine using subjects (minimum of 3 months non-tobacco/nicotine use prior to first dose).
  • Subjects with two normal (non-diseased) eyes, defined as nonclinically significant in the opinion of the investigator.
  • Intraocular pressure between 14 and 20 mm Hg (inclusive) in each eye at Screening/Qualification.
  • Best-corrected visual acuity (BCVA) in each eye of 20/40 or better.
  • Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements.

Exclusion Criteria:

  • Chronic or acute ophthalmic disease including glaucoma, macular degeneration, clinically significant cataract (primary or secondary). Previous cataract surgery.
  • Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
  • Previous glaucoma intraocular surgery or glaucoma laser procedures.
  • Refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  • Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months (e.g., laser treatment for glaucoma or retina).
  • Evidence of ocular infection, inflammation, cystoid macular edema, clinically significant blepharitis or conjunctivitis at (Screening/ Qualification), or a history of herpes simplex keratitis.
  • Ocular medication of any kind within 30 days of Screening/ Qualification
  • Any abnormality preventing reliable applanation tonometry of either eye.
  • Central corneal thickness greater than 600 µm.
  • Cannot demonstrate proper delivery of the eye drop.
  • Blood donations or blood loss, within the past 3 months, that would put the patient at risk with the multiple blood samples required in the present study.
  • Clinically significant abnormalities in laboratory tests at screening.
  • Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study.
  • Participation in any investigational study within the past 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 status of preclinical safety program, 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 two months. 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 or serum pregnancy test result at the screening examination and must not intend to become pregnant during the study.

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): NCT01997879


Locations
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United States, Arizona
Celerion
Phoenix, Arizona, United States, 85283
Sponsors and Collaborators
Aerie Pharmaceuticals

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Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01997879     History of Changes
Other Study ID Numbers: AR13324-CS101
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: November 2013
Additional relevant MeSH terms:
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Ophthalmic Solutions
Pharmaceutical Solutions