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Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00567762
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Completed
Phase Phase 3
Start date February 2004
Completion date September 2004

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