Ocular Penetration of Topical Tacrolimus Eye Drops

Ocular Penetration of Topical Tacrolimus Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02794610
• Other study ID #: 2015-01(P)
• Status: Recruiting
• Phase: N/A
• First received: May 26, 2016
• Last updated: June 8, 2016
• Start date: May 2016
• Est. completion date: July 2016

Study information

• Verified date: May 2016
• Source: The Eye Center and The Eye Foundation for Research in Ophthalmology
• Contact: Ssmir S Shoughy, MD
• Phone: +966 11 464 9614
• Email: samir.shawki[@]hotmail.com
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any age or gender

• Patients scheduled for routine cataract surgery

• Clear healthy cornea

Exclusion Criteria:

• Corneal pathology

• Ocular surface disease

• Intraocular inflammation

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ocular Penetration of Topical Tacrolimus

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Saudi Arabia	The Eye Center	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
The Eye Center and The Eye Foundation for Research in Ophthalmology

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No