Clinical trial NCT01997879: Study Assessing Ocular and Systemic Safety of AR-13324 in Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-11-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Pharmacokinetic Assessment
timeFrame: 8 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Celerion
state: Arizona
Study officials:
References: