Clinical Trial: Phase III Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Placebo-controlled, Double-masked Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Vernal Keratoconjunctivitis
Brief Summary: To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in patients with vernal keratoconjunctivitis
Detailed Summary: 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.
Sponsor: Astellas Pharma Inc
Current Primary Outcome: Mean change from the baseline (before the treatment) in total score for objective clinical signs at the final observation [ Time Frame: 4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign [ Time Frame: Week 1, 2 and 4 ]
- Subjective symptom score (Visual Analog Scale) [ Time Frame: 4 weeks ]
- The improvement rate of subjective symptoms [ Time Frame: 4 weeks ]
Original Secondary Outcome: Same as current
Information By: Astellas Pharma Inc
Dates:
Date Received: December 3, 2007
Date Started: February 2004
Date Completion:
Last Updated: August 29, 2014
Last Verified: August 2014
