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Status unknownNCT02794610Updated Jun 9, 2016

Ocular Penetration of Topical Tacrolimus Eye Drops

An interventional study of Tacrolimus in Ocular Penetration of Topical Tacrolimus, sponsored by The Eye Center and The Eye Foundation for Research in Ophthalmology. Status unknown at 1 site in Saudi Arabia. Per ClinicalTrials.gov, last updated 2016-06-09.

Sponsored by The Eye Center and The Eye Foundation for Research in Ophthalmology · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Sex
All
01

Study 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.

02

Conditions studied

  • Ocular Penetration of Topical Tacrolimus

Keywords

  • Tacrolimus
  • Ocular penetration
  • Topical
03

In context

Lead sponsor

The Eye Center and The Eye Foundation for Research in Ophthalmology is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Corneal pathology
  • Ocular surface disease
  • Intraocular inflammation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • 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.

    Drug: 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.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
  • The Eye Center
    Riyadh, 11534, Saudi Arabia
    Recruiting
08

References and documents

Publications

  • 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. PubMed 32025589 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02794610
Lead sponsor
The Eye Center and The Eye Foundation for Research in Ophthalmology
Responsible party
Samir S. Shoughy, MD, FRCS (Glasg.) (Principal Investigator, The Eye Center and The Eye Foundation for Research in Ophthalmology) — Principal investigator
First posted
Jun 9, 2016
Start date
May 2016
Primary completion
Jun 2016 (estimated)
Completion
Jul 2016 (estimated)
Last update
Jun 9, 2016

Study contacts

Ssmir S Shoughy, MD
Contact
samir.shawki@hotmail.com
+966 11 464 9614 ext. 222

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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