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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Secondary ID [1] 0 0
192371-016
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Conjunctivitis 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Treatment Responders
Timepoint [1] 0 0
Baseline, Month 2
Secondary outcome [1] 0 0
Percentage of Punctate Corneal Staining Responders
Timepoint [1] 0 0
Month 2
Secondary outcome [2] 0 0
Percentage of Patients With an Improvement in the Composite Symptom Score
Timepoint [2] 0 0
Baseline, Month 2
Secondary outcome [3] 0 0
Percentage of Patients With an Improvement in the Punctate Corneal Staining Score
Timepoint [3] 0 0
Baseline, Month 2

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
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2011
Sample size
Target
Accrual to date
Final
176
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- Randwick
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Prague
Country [4] 0 0
France
State/province [4] 0 0
Burgundy
Country [5] 0 0
Germany
State/province [5] 0 0
Bavaria
Country [6] 0 0
India
State/province [6] 0 0
Karnataka
Country [7] 0 0
Israel
State/province [7] 0 0
Tel Aviv
Country [8] 0 0
Italy
State/province [8] 0 0
Rome
Country [9] 0 0
New Zealand
State/province [9] 0 0
Wellington
Country [10] 0 0
Spain
State/province [10] 0 0
Valladolid
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Tyne and Wear

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00884585
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00884585