Ocular Penetration of Topical Tacrolimus Eye Drops

NCT ID: NCT02794610

Last Updated: 2016-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ocular Penetration of Topical Tacrolimus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Any age or gender
* Patients scheduled for routine cataract surgery
* Clear healthy cornea

Exclusion Criteria

* Corneal pathology
* Ocular surface disease
* Intraocular inflammation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Eye Center and The Eye Foundation for Research in Ophthalmology

OTHER

Sponsor Role lead

Responsible Party

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Samir S. Shoughy, MD, FRCS (Glasg.)

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Eye Center

Riyadh, , Saudi Arabia

Site Status RECRUITING

Countries

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Saudi Arabia

Central Contacts

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Ssmir S Shoughy, MD

Role: CONTACT

+966 11 464 9614 ext. 222

Facility Contacts

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Samir S Shoughy, MD

Role: primary

+966 11 464 9614 ext. 222

References

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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.

Reference Type DERIVED
PMID: 32025589 (View on PubMed)

Other Identifiers

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2015-01(P)

Identifier Type: -

Identifier Source: org_study_id

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