NCT00567918

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Keratoconjunctivitis
• Conjunctivitis

Interventions

Type	Name	Description
DRUG	FK506	Ophthalmic suspension

Timeline

• Start date: 2004-05-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2007-12-05
• Last updated: 2008-04-04

Locations

8 sites across 1 country: Japan