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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 Responders

Percentage 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

Page last updated: August 20, 2015

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