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

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%	Phase 3

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:

Genetics Home Reference related topics: keratitis-ichthyosis-deafness syndrome

MedlinePlus related topics: Pinkeye

Drug Information available for: Cyclosporine

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Percentage of Treatment Responders [ Time Frame: Baseline, Month 2 ] [ Designated as safety issue: No ]
Treatment responders are defined as patients with a ≥ 1 grade improvement from baseline in punctate corneal staining score and a ≥ 4 grade improvement from baseline in composite symptom score in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 (0 is ≤2 dots and 5 is >316 dots (approximately) or ulcer/erosion). The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). The composite symptom score (0 to 15) is the sum of 5 symptoms (each symptom is assessed on a scale of 0=absent to 3=severe).

Secondary Outcome Measures:

Percentage of Punctate Corneal Staining Responders [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
Punctate corneal staining responders defined as patients achieving a punctate corneal staining score of 0 or 1 in the study eye. Punctate corneal staining is assessed on a scale of 0 to 5 where 0 is ≤2 dots, 1 is >2 dots but ≤ 10 dots, 2 is > 10 dots but ≤ 32 dots, 3 is > 32 dots but ≤ 100 dots (approximately), 4 is > 100 dots (approximately) but ≤ 316 dots (approximately), and 5 is >316 dots (approximately) or ulcer/erosion.
Percentage of Patients With an Improvement in the Composite Symptom Score [ Time Frame: Baseline, Month 2 ] [ Designated as safety issue: No ]
Composite symptom score improvement is defined as a 4 or more grade decrease from baseline in composite symptom score in the study eye. The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). Each of the 5 symptoms is assessed on a scale of 0=absent to 3=severe. The composite symptom score is the sum of all 5 individual symptom scores, where 0 is no symptoms and 15 is the most severe symptoms.
Percentage of Patients With an Improvement in the Punctate Corneal Staining Score [ Time Frame: Baseline, Month 2 ] [ Designated as safety issue: No ]
Punctate corneal staining improvement is defined as a 1 or more grade decrease from baseline in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 where 0 is ≤2 dots, 1 is >2 dots but ≤ 10 dots, 2 is > 10 dots but ≤ 32 dots, 3 is > 32 dots but ≤ 100 dots (approximately), 4 is > 100 dots (approximately) but ≤ 316 dots (approximately), and 5 is >316 dots (approximately) or ulcer/erosion.

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
Experimental: Cyclosporine Ophthalmic Solution (COS) followed by COS Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.	Drug: Cyclosporine 0.010% Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
Placebo followed by COS Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day.	Drug: Cyclosporine Vehicle Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months. Drug: Cyclosporine 0.010% Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.

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, Burgundy, France
Germany

Munich, Bavaria, Germany
India

Bangalore, Karnataka, India
Israel

Tel Aviv, Israel
Italy

Rome, Italy
New Zealand

Wellington, New Zealand
Spain

Valladolid, 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
Results First Received:	September 27, 2012
Last Updated:	November 2, 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 May 19, 2013