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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00567762
Other study ID # FJ-506D-AC09
Secondary ID
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
Est. primary completion date
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


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
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