Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis - Full Text View

Sponsor:	Allergan
Information provided by (Responsible Party):	Allergan
ClinicalTrials.gov Identifier:	NCT00884585

Purpose

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

Condition	Intervention	Phase
Atopic Conjunctivitis	Drug: Cyclosporine Vehicle Drug: Cyclosporine 0.010% Drug: Open-labeled Cyclosporine 0.010%	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye

Drug Information available for: Cyclosporine Cyclosporin

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

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) [ Time Frame: Month 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The proportion of patients who achieve a 1 or more grade improvement in punctate corneal staining score (analysis of responders) [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
The proportion of patients with a 4 or more grade improvement in composite symptom score (analysis of responders) [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
The proportion of patients who achieve a 0 or 1 grade in punctate corneal staining score (analysis of responders) [ Time Frame: Month 2 ] [ Designated as safety issue: No ]

Enrollment:	176
Study Start Date:	May 2009
Study Completion Date:	July 2011
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Cyclosporine Vehicle Double-masked Vehicle QID	Drug: Cyclosporine Vehicle 1 drop of vehicle eyedrops in both eyes four times daily for 3 months
Experimental: Cyclosporine 0.010% Double-masked Cyclosporine 0.010% QID	Drug: Cyclosporine 0.010% 1 drop of Cyclosporine 0.010% eyedrops in both eyes four times daily for 3 months
Active Comparator: Open-labeled Cyclosporine 0.010% Open-labeled Cyclosporine 0.010% QID for 6 months and QID or BID for 3 more months for a total of 9 months of exposure	Drug: Open-labeled Cyclosporine 0.010% 1 drop of Cyclosporine 0.010% eyedrops in both eyes four times daily for 6 months and then four times daily or two times daily for 3 more months for a total of 9 months exposure

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884585

Locations

United States, California

Bakersfield, California, United States
Australia, New South Wales

Randwick, New South Wales, Australia
Canada, Ontario

Ottawa, Ontario, Canada
Czech Republic

Prague, Czech Republic
France

Dijon, Burgandy, France
Germany

Munich, Bavaria, Germany
India

Bangalore, Karnataka, India
Israel

Tel Aviv, Israel
Italy

Rome, Italy
New Zealand

Wellington, New Zealand
Spain

Vallodolid, Spain
United Kingdom

Newcastle-upon-tyne, Tyne and Wear, United Kingdom

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00884585 History of Changes
Other Study ID Numbers:	192371-016
Study First Received:	April 17, 2009
Last Updated:	January 26, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Conjunctivitis
Conjunctivitis, Allergic
Keratoconjunctivitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Keratitis
Corneal Diseases
Cyclosporins
Cyclosporine

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012