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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AR-13324 Ophthalmic Solution, 0.02%

• Registration Number: NCT01997879
• Lead Sponsor: Aerie Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2013-11-19
• Study First Submitted QC: 2013-11-25
• Study First Posted: 2013-11-28
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-18
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AR-13324 Ophthalmic Solution, 0.02%	AR-13324 Ophthalmic Solution, 0.02%	Eyedrop

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic Assessment	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.

Trial Locations

Locations (1)

Celerion; 🇺🇸 Phoenix, Arizona, United States