Ocular Penetration of Topical Tacrolimus Eye Drops
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
June 9, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedJune 9, 2016
May 1, 2016
1 month
May 26, 2016
June 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Detection of the concentration of tacrolimus ( nanograms/milliliter) in the anterior chamber following ocular topical application.
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
Study Arms (1)
Topical tacrolimus
EXPERIMENTALTen 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.
Interventions
Topical tacrolimus 0.05% eye drops will be instilled into the eyes of patients every minute for 5 minutes. After 15 minutes, at the time of cataract surgery, aqueous samples will be collected and will be subjected to detection of presence and level of tacrolimus.
Eligibility Criteria
You may qualify if:
- Any age or gender
- Patients scheduled for routine cataract surgery
- Clear healthy cornea
You may not qualify if:
- Corneal pathology
- Ocular surface disease
- Intraocular inflammation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Eye Center
Riyadh, 11534, Saudi Arabia
Related Publications (1)
Shoughy SS, Aljassar FM, Tabbara KF. Aqueous penetration of topical tacrolimus. Am J Ophthalmol Case Rep. 2020 Jan 17;17:100582. doi: 10.1016/j.ajoc.2019.100582. eCollection 2020 Mar.
PMID: 32025589DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 26, 2016
First Posted
June 9, 2016
Study Start
May 1, 2016
Primary Completion
June 1, 2016
Study Completion
July 1, 2016
Last Updated
June 9, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share