Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis

Phase III, Long-Term, Open-Label, Extension Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients

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

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.

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