NCT00567762

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

A Randomized, Placebo-controlled, Double-masked Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Vernal Keratoconjunctivitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Keratoconjunctivitis
• Conjunctivitis

Interventions

Type	Name	Description
DRUG	FK506	Opthalmic suspension
DRUG	placebo	placebo eye drops

Timeline

• Start date: 2004-02-01
• Completion: 2004-09-01
• First posted: 2007-12-05
• Last updated: 2014-09-01

Locations

8 sites across 1 country: Japan