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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00884585
Registration number
NCT00884585
Ethics application status
Date submitted
17/04/2009
Date registered
21/04/2009
Date last updated
4/11/2012
Titles & IDs
Public title
Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis
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Scientific title
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Secondary ID [1]
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192371-016
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atopic Conjunctivitis
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Inflammatory and Immune System
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cyclosporine Vehicle
Treatment: Drugs - Cyclosporine 0.010%
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.
Other: 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.
Treatment: Drugs: Cyclosporine Vehicle
Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Treatment Responders
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Assessment method [1]
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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).
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Timepoint [1]
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Baseline, Month 2
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Secondary outcome [1]
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Percentage of Punctate Corneal Staining Responders
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Assessment method [1]
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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.
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Timepoint [1]
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Month 2
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Secondary outcome [2]
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Percentage of Patients With an Improvement in the Composite Symptom Score
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, Month 2
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Secondary outcome [3]
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Percentage of Patients With an Improvement in the Punctate Corneal Staining Score
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, Month 2
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Eligibility
Key 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
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2011
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Sample size
Target
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Accrual to date
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Final
176
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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- Randwick
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Recruitment postcode(s) [1]
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- Randwick
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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Canada
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State/province [2]
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Ontario
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Country [3]
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Czech Republic
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State/province [3]
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Prague
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Country [4]
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France
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State/province [4]
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Burgundy
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Country [5]
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Germany
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State/province [5]
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Bavaria
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Country [6]
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India
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State/province [6]
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Karnataka
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Country [7]
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Israel
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State/province [7]
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Tel Aviv
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Country [8]
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Italy
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State/province [8]
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Rome
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Country [9]
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New Zealand
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State/province [9]
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Wellington
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Country [10]
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Spain
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State/province [10]
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Valladolid
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Country [11]
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United Kingdom
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State/province [11]
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Tyne and Wear
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Allergan
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00884585
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Allergan
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00884585
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