Ocular Penetration of Topical Tacrolimus Eye Drops
Overview
- Phase
- Not Applicable
- Sponsor
- The Eye Center and The Eye Foundation for Research in Ophthalmology
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Detection of the concentration of tacrolimus ( nanograms/milliliter) in the anterior chamber following ocular topical application.
Overview
Brief Summary
Investigators aim to evaluate the ocular penetration of topical tacrolimus 0.03% eye drops.
Topical tacrolimus 0.03% will be instilled into the eyes of patients 15 minutes before cataract surgery. Aqueous samples will be collected at the time of cataract surgery and will be subjected to detection of presence and level of tacrolimus.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Any age or gender
- •Patients scheduled for routine cataract surgery
- •Clear healthy cornea
Exclusion Criteria
- •Corneal pathology
- •Ocular surface disease
- •Intraocular inflammation
Arms & Interventions
Topical tacrolimus
Ten patients will be include. Topical tacrolimus 0.05% will be instilled into the eyes of patients 15 minutes before cataract surgery. Aqueous samples will be collected at the time of cataract surgery and will be subjected to detection of presence and level of tacrolimus.
Intervention: Tacrolimus (Drug)
Outcomes
Primary Outcomes
Detection of the concentration of tacrolimus ( nanograms/milliliter) in the anterior chamber following ocular topical application.
Time Frame: From date of obtaining the aqueous samples until getting the laboratory results of concentration of topical tacrolimus in the aqueous humor up to 2 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Samir S. Shoughy, MD, FRCS (Glasg.)
Principal Investigator
The Eye Center and The Eye Foundation for Research in Ophthalmology