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

This study is ongoing, but not recruiting participants.

First Received: March 2, 2007 No Changes Posted

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

MedlinePlus related topics: Pinkeye

Drug Information available for: Tacrolimus anhydrous Tacrolimus

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

No publications provided

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

Study placed in the following topic categories:

Hypersensitivity
Immunologic Factors
Conjunctivitis, Allergic
Eye Diseases
Hypersensitivity, Immediate

Tacrolimus
Conjunctivitis
Immunosuppressive Agents
Conjunctival Diseases

Additional relevant MeSH terms:

Hypersensitivity
Immunologic Factors
Immune System Diseases
Conjunctivitis, Allergic
Eye Diseases
Physiological Effects of Drugs

Hypersensitivity, Immediate
Tacrolimus
Conjunctivitis
Immunosuppressive Agents
Pharmacologic Actions
Conjunctival Diseases

ClinicalTrials.gov processed this record on May 07, 2009