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

Astellas

Status and phase: Completed; Phase 3

Conditions: Conjunctivitis; Keratoconjunctivitis

Treatments: Drug: placebo; Drug: FK506

Study type: Interventional

Funder types: Industry

Identifiers

NCT00567762

FJ-506D-AC09

Details and patient eligibility

About

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

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

FK506 ophthalmic suspension

Treatment:

Drug: FK506

2

Placebo Comparator group

Description:

Base of eye drops

Treatment:

Drug: placebo