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

NCT01997879 | Completed Phase 1

• 1 other identifier: AR13324-CS101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

AR-13324 Ophthalmic Solution, 0.02%

EXPERIMENTAL

Eyedrop

Drug: AR-13324 Ophthalmic Solution, 0.02%

Interventions

AR-13324 Ophthalmic Solution, 0.02% DRUG

Eyedrop

AR-13324 Ophthalmic Solution, 0.02%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aerie Pharmaceuticals: lead

Study Sites (1)

Celerion

Phoenix, Arizona, 85283, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 28, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: August 22, 2023

Record last verified: 2023-08

Locations

US (1)