Status:

COMPLETED

Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis

Lead Sponsor:

Allergan

Conditions:

Atopic Conjunctivitis

Eligibility:

All Genders

12+ years

Phase:

PHASE3

Brief Summary

This study evaluates the efficacy and safety of Cyclosporine 0.010% eye drops in the treatment of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye). The study consists of a doub...

Eligibility Criteria

Inclusion

  • Have a clinical diagnosis of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye)
  • Be on stable doses of your current AKC medications for at least 2 weeks

Exclusion

  • You have used contact lenses within 48 hours of Day 1 or think you may have to wear contact lenses during the study
  • You are pregnant, breastfeeding, or planning to become pregnant during the study
  • You have used a calcineurin inhibitors (e.g. topical tacrolimus or topical pimecrolimus) on or around your eyes including eyelids within 4 weeks

Key Trial Info

Start Date :

May 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2011

Estimated Enrollment :

176 Patients enrolled

Trial Details

Trial ID

NCT00884585

Start Date

May 1 2009

End Date

July 1 2011

Last Update

November 5 2012

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Bakersfield, California, United States

2

Randwick, New South Wales, Australia

3

Ottawa, Ontario, Canada

4

Prague, Czechia