Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis
Information source: Allergan
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atopic Conjunctivitis
Intervention: Cyclosporine Vehicle (Drug); Cyclosporine 0.010% (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Allergan Official(s) and/or principal investigator(s): Medical Director, Study Director, Affiliation: Allergan
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 double-masked phase, and open-labeled phase, and an open-labeled
maintenance phase. For the first 3 months of the study, patients will receive either masked
Cyclosporine 0. 010% eye drops or vehicle four times daily; for the next 6 months, patients
may receive open-labeled Cyclosporine 0. 010% eye drops four times daily. At month 9,
patients who are in remission, will be re-randomized to receive either open-labeled
Cyclosporine 0. 010% eye drops four times daily or twice daily.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percentage of Treatment Responders
Secondary outcome: Percentage of Punctate Corneal Staining RespondersPercentage of Patients With an Improvement in the Composite Symptom Score Percentage of Patients With an Improvement in the Punctate Corneal Staining Score
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Prague, Czech Republic
Tel Aviv, Israel
Rome, Italy
Wellington, New Zealand
Valladolid, Spain
Munich, Bavaria, Germany
Dijon, Burgundy, France
Bakersfield, California, United States
Bangalore, Karnataka, India
Randwick, New South Wales, Australia
Ottawa, Ontario, Canada
Newcastle-upon-tyne, Tyne and Wear, United Kingdom
Additional Information
Starting date: May 2009
Last updated: November 2, 2012
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