Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis | Completed
Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis
Health Conditions
  • Atopic Conjunctivitis
Completed
Recruitment Status
NCT00884585
Primary Trial ID Number
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.
Primary Outcome Measures
  • Percentage of Treatment Responders; Baseline, Month 2
Secondary Outcome Measures
  • Percentage of Punctate Corneal Staining Responders; Month 2; Percentage of Patients With an Improvement in the Composite Symptom Score; Baseline, Month 2; Percentage of Patients With an Improvement in the Punctate Corneal Staining Score; Baseline, Month 2
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
United States; Australia; Canada; Czech Republic; France; Germany; India; Israel; Italy; New Zealand; Spain; United Kingdom
Participant Sex
Both
Participant Age Range
12 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
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Participant Inclusion 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
Participant Exclusion 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
Interventions
Drug; Cyclosporine Vehicle; Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.; [Placebo followed by COS]; 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.; [Cyclosporine Ophthalmic Solution (COS) followed by COS, Placebo followed by COS]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific Title
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Secondary Trial Identifying Number
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Website
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Study Funded By
Allergan
Funder Type
Sorry, this information is not available
Study Sponsored By
Allergan
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

17 Apr 2009

Last Updated

02 Nov 2012

Date Record Refreshed on UKCTG

01 Aug 2015