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

An Open-label Study Assessing the Ocular and Systemic Safety and Systemic Absorption of AR-13324 Ophthalmic Solution, 0.02% in Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: AR-13324 Ophthalmic Solution, 0.02%

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85283
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AR-13324 Ophthalmic Solution, 0.02%; Eyedrop	Drug: AR-13324 Ophthalmic Solution, 0.02%; Eyedrop

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Assessment	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.	8 Days

Collaborators and Investigators

• Sponsor: Aerie Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: November 19, 2013
• First Submitted That Met QC Criteria: November 25, 2013
• First Posted (Estimated): November 28, 2013

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: AR13324-CS101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No