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Ocular Penetration of Topical Tacrolimus Eye Drops

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02794610
Enrollment
10
Registered
2016-06-09
Start date
2016-05-31
Completion date
2016-07-31
Last updated
2016-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Penetration of Topical Tacrolimus

Keywords

Tacrolimus, Ocular penetration, Topical

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.

Interventions

DRUGTacrolimus

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.

Sponsors

The Eye Center and The Eye Foundation for Research in Ophthalmology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frame
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

Countries

Saudi Arabia

Contacts

Primary ContactSsmir S Shoughy, MD
samir.shawki@hotmail.com+966 11 464 9614

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026