Ocular Penetration of Topical Tacrolimus Eye Drops
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|ClinicalTrials.gov Identifier: NCT02794610|
Recruitment Status : Unknown
Verified May 2016 by Samir S. Shoughy, MD, FRCS (Glasg.), The Eye Center and The Eye Foundation for Research in Ophthalmology.
Recruitment status was: Recruiting
First Posted : June 9, 2016
Last Update Posted : June 9, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Ocular Penetration of Topical Tacrolimus||Drug: Tacrolimus||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||July 2016|
Experimental: 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.
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794610
|Contact: Ssmir S Shoughy, MD||+966 11 464 9614 ext firstname.lastname@example.org|
|The Eye Center||Recruiting|
|Riyadh, Saudi Arabia, 11534|
|Contact: Samir S Shoughy, MD +966 11 464 9614 ext 222 email@example.com|