Efficacy and Safety Study of Cyclosporine 0.010% to Treat AtopicKeratoconjunctivitis
Phase 3
Completed
- Registration Number
- CTRI/2010/091/000590
- Lead Sponsor
- Allergan, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
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 Criteria
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients with a 1 or more grade improvement in punctate corneal staining score and a 4 or more grade improvement in composite symptom score (analysis of responders).Timepoint: Month 2
- Secondary Outcome Measures
Name Time Method The proportion of patients who achieve a 0 or 1 grade in punctate corneal staining score (Analysis of Responders)Timepoint: Month 2;The proportion of patients who achieve a 1 or more grade improvement in punctate corneal staining score (Analysis of Responders)Timepoint: Month 2;The proportion of patients with a 4 or more grade improvement in composite symptom score (Analysis of Responders)Timepoint: Month 2