Back to resultsTopical Tacrolimus 0.03% Ointment for Intractable Allergic Conjunctivitis: An Open Label Pilot Study
Primary Purpose
Allergic Conjunctivitis
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Tacrolimus 0.03% ointment (Protopic)
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- Subjects included if they were > 5 years old and suffered from intractable allergic conjunctivitis
Exclusion Criteria:
- pregnancy or breastfeeding,history of herpetic eye disease,transplant patients concomitant administration of drugs inhibiting cytochrome CYP3A4, hypersensitivity to macrolides
Sites / Locations
- Assaf Harofeh Medical Center, Department of Ophthalmology
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00443105
First Posted
March 2, 2007
Last Updated
March 2, 2007
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00443105
Brief Title
Topical Tacrolimus 0.03% Ointment for Intractable Allergic Conjunctivitis: An Open Label Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the efficacy, tolerance and safety of tacrolimus 0.03% ointment in the treatment of intractable allergic conjunctivitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tacrolimus 0.03% ointment (Protopic)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Eligibility Criteria
Inclusion Criteria:
Subjects included if they were > 5 years old and suffered from intractable allergic conjunctivitis
Exclusion Criteria:
pregnancy or breastfeeding,history of herpetic eye disease,transplant patients concomitant administration of drugs inhibiting cytochrome CYP3A4, hypersensitivity to macrolides
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Zadok, MD
Organizational Affiliation
Assaf Harofeh Medical Center, Tel Aviv University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assaf Harofeh Medical Center, Department of Ophthalmology
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Topical Tacrolimus 0.03% Ointment for Intractable Allergic Conjunctivitis: An Open Label Pilot Study
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