Phase III Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00567762

Purpose

To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in patients with vernal keratoconjunctivitis

Condition	Intervention	Phase
Keratoconjunctivitis Conjunctivitis	Drug: FK506 Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Placebo-Controlled, Double-Masked Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Vernal Keratoconjunctivitis

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye

Drug Information available for: Tacrolimus anhydrous Tacrolimus

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Mean change from the baseline (before the treatment) in total score for objective clinical signs at the final observation [ Time Frame: 4 weeks ]

Secondary Outcome Measures:

Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign [ Time Frame: Week 1, 2 and 4 ]
Subjective symptom score (Visual Analog Scale) [ Time Frame: 4 weeks ]
The improvement rate of subjective symptoms [ Time Frame: 4 weeks ]

Enrollment:	56
Study Start Date:	February 2004
Study Completion Date:	September 2004

Arms	Assigned Interventions
1: Experimental FK506 ophthalmic suspension	Drug: FK506 Opthalmic suspension
2: Placebo Comparator Base of eye drops	Drug: placebo placebo eye drops

Detailed Description:

0.1% FK506 ophthalmic suspension were administered twice-a-day to patients with vernal keratoconjunctivitis in whom treatment with topical anti-allergic agents had been ineffective. The primary efficacy endpoint was the mean change from the baseline (before the treatment)in total score for objective clinical signs at the final observation. The safety of FK506 ophthalmic suspension was also investigated.

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Vernal keratoconjunctivitis patients diagnosed by "Guideline of diagnosis and treatment of allergic conjunctival disease"
Patients with type I reactions defined by skin testing, antibody measurement, etc.
Age over 6 years old

Exclusion Criteria:

Subjects receiving systemic administration or subconjunctival injection of corticosteroid or immunosuppressants(ophthalmic and systemic medications) within 2-weeks of initiation of the study
Subjects needed to wear contact lenses during treatment period on a testing eye
Subjects complicating an eye infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567762

Locations

Japan

Hokkaido, Japan

Tochigi, Japan

Tokyo, Japan

Osaka, Japan

Kagoshima, Japan

Kochi, Japan

Miyazaki, Japan

Ehime, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Central Contact

Astellas Pharma Inc

More Information

Additional Information:

Link to ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	FJ-506D-AC09
Study First Received:	December 3, 2007
Last Updated:	February 25, 2009
ClinicalTrials.gov Identifier:	NCT00567762 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:

Keratoconjunctivitis
vernal keratoconjunctivitis
FK506
Tacrolimus

Additional relevant MeSH terms:

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

Keratoconjunctivitis
Immunosuppressive Agents
Pharmacologic Actions
Conjunctival Diseases
Hypersensitivity
Hypersensitivity, Immediate
Keratitis

ClinicalTrials.gov processed this record on February 08, 2010