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

Sponsored by:	Allergan
Information provided by:	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:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

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 2 or more 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 improvement in composite symptom score (analysis of responders) [ Time Frame: Month 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The mean change for all patients from baseline in punctate corneal staining score [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
The mean change for all patients from baseline in composite symptom score of the following symptoms (Itching, Tearing, Ocular Discomfort, Photophobia, & Mucous Discharge) [ Time Frame: Month 2 ] [ Designated as safety issue: No ]

Estimated Enrollment:	124
Study Start Date:	April 2009
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Double-masked Vehicle QID	Drug: Cyclosporine Vehicle 1 drop of vehicle eyedrops in both eyes four times daily for 3 months
2: Experimental 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
3: Active Comparator 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

Contacts

Contact: Allergan Inc.

clinicaltrials@allergan.com

Locations

United States, California
	Recruiting
Bakersfield, California, United States
Australia
	Recruiting
Randwick, Australia
Canada, Ontario
	Recruiting
Ottawa, Ontario, Canada
France
	Not yet recruiting
Dijon, France
Germany
	Not yet recruiting
Munich, Germany
New Zealand
	Not yet recruiting
Wellington, New Zealand
Spain
	Not yet recruiting
Vallodolid, Spain
United Kingdom
	Not yet recruiting
Newcastle-upon-tyne, United Kingdom

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	192371-016
Study First Received:	April 17, 2009
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00884585 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Infective Agents
Corneal Diseases
Cyclosporine
Immunologic Factors
Conjunctivitis, Allergic
Eye Diseases
Conjunctivitis
Tetrahydrozoline
Keratoconjunctivitis

Cyclosporins
Immunosuppressive Agents
Conjunctival Diseases
Hypersensitivity
Antifungal Agents
Hypersensitivity, Immediate
Keratitis
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Infective Agents
Corneal Diseases
Cyclosporine
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Conjunctivitis, Allergic
Immune System Diseases
Eye Diseases
Physiological Effects of Drugs
Enzyme Inhibitors
Conjunctivitis
Immunosuppressive Agents

Keratoconjunctivitis
Cyclosporins
Pharmacologic Actions
Conjunctival Diseases
Hypersensitivity
Therapeutic Uses
Antifungal Agents
Hypersensitivity, Immediate
Keratitis
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on August 24, 2009