Topical Tacrolimus 0.03% Ointment for Intractable Allergic Conjunctivitis: An Open Label Pilot Study

This study is ongoing, but not recruiting participants.

Sponsored by:	Assaf-Harofeh Medical Center
Information provided by:	Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:	NCT00443105

Purpose

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.

Condition	Intervention	Phase
Allergic Conjunctivitis	Drug: Tacrolimus 0.03% ointment (Protopic)	Phase II

Drug Information available for: Tacrolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Eligibility

Ages Eligible for Study:	5 Years and older
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443105

Locations

Israel
Assaf Harofeh Medical Center, Department of Ophthalmology
Zerifin, Israel, 70300

Sponsors and Collaborators

Assaf-Harofeh Medical Center

Investigators

Principal Investigator:

David Zadok, MD

Assaf Harofeh Medical Center, Tel Aviv University

More Information

Study ID Numbers:	20050321
Study First Received:	March 2, 2007
Last Updated:	March 2, 2007
ClinicalTrials.gov Identifier:	NCT00443105
Health Authority:	Israel: Ministry of Health

Study placed in the following topic categories:

Hypersensitivity
Conjunctivitis, Allergic
Eye Diseases
Hypersensitivity, Immediate

Tacrolimus
Conjunctivitis
Conjunctival Diseases

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009