Healthy
Conditions
Brief summary
The purpose of this study is to assess systemic safety and absorption of AR-13324 in healthy volunteers.
Interventions
DRUGAR-13324 Ophthalmic Solution, 0.02%
Eyedrop
Sponsors
Aerie Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed