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

Conjunctivitis Clinical Trial

Official title:

A Randomized, Placebo-controlled, Double-masked Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Vernal Keratoconjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567762
• Other study ID #: FJ-506D-AC09
• Status: Completed
• Phase: Phase 3
• First received: December 3, 2007
• Last updated: August 29, 2014
• Start date: February 2004
• Est. completion date: September 2004

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic
• Keratoconjunctivitis

Intervention

Drug:
• FK506
Opthalmic suspension
• placebo
placebo eye drops

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from the baseline (before the treatment) in total score for objective clinical signs at the final observation		4 weeks
Secondary	Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign		Week 1, 2 and 4
Secondary	Subjective symptom score (Visual Analog Scale)		4 weeks
Secondary	The improvement rate of subjective symptoms		4 weeks

External Links

•   Link to Results on JAPIC - enter 140570 in the JapicCTI-RNo. field