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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
Sponsor:
Information provided by (Responsible Party):
Samir S. Shoughy, MD, FRCS (Glasg.), The Eye Center and The Eye Foundation for Research in Ophthalmology

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.


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)
Primary Purpose: Treatment
Study Start Date : May 2016
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
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
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.




Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Corneal pathology
  • Ocular surface disease
  • Intraocular inflammation

Information from the National Library of Medicine

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


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

Locations
Saudi Arabia
The Eye Center Recruiting
Riyadh, Saudi Arabia, 11534
Contact: Samir S Shoughy, MD    +966 11 464 9614 ext 222    samir.shawki@hotmail.com   
Sponsors and Collaborators
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
ClinicalTrials.gov Identifier: NCT02794610     History of Changes
Other Study ID Numbers: 2015-01(P)
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Samir S. Shoughy, MD, FRCS (Glasg.), The Eye Center and The Eye Foundation for Research in Ophthalmology:
Tacrolimus
Ocular penetration
Topical

Additional relevant MeSH terms:
Eye Injuries, Penetrating
Eye Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Wounds, Penetrating
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action