Phase III, Long-Term, Open-Label, Extension 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: FK506

Study type: Interventional

Funder types: Industry

Identifiers

NCT00567918

FJ-506D-AC10

Details and patient eligibility

About

To investigate the long-term efficacy and safety of FK506 ophthalmic suspension in patients with vernal keratoconjunctivitis

Full description

To give a chance of continuous use of 0.1% FK506 ophthalmic suspension to patients with vernal keratoconjunctivitis who were enrolled in the FJ-506D-AC09 study, long-term safety and efficacy were evaluated. Primary efficacy endpoint was the mean change from the baseline (before the treatment) in total score for objective clinical signs.

Enrollment: 52 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Vernal keratoconjunctivitis patients who were enrolled in the FJ-506D-AC09 study
• Patients who wish to receive continuous administration of FK506 ophthalmic suspension

Exclusion criteria

• Subjects who needed prohibited concomitant therapy at the initiation of the study
• Subjects who needed to wear contact lenses during treatment period on a testing eye
• Subjects with complicating an eye infection

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

1

Experimental group

Description:

FK506 ophthalmic suspension

Treatment:

Drug: FK506