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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Atopic Conjunctivitis
Unfortunately contact details are not available for this trial.
Primary Contact Details
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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Cyclosporine Vehicle, Drug : Cyclosporine 0.010%

Study Arm Groups : Placebo followed by COS, Cyclosporine Ophthalmic Solution (COS) followed by COS, Placebo followed by COS

Intervention Type
See Interventions above
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
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
12 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
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
This is in the inclusion criteria above
Trial Location(s)
Research Site
Newcastle-upon-Tyne
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, Australia, Canada, Czech Republic, France, Germany, India, Israel, Italy, New Zealand, Spain, United Kingdom
Scientific Title
Sorry, this information is not available
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
192371-016
Sponsor(s)
Allergan
Key Dates

Recruitment Start Date

May 2009

Recruitment End Date

Oct 2010

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

17 Apr 2009

Last Updated

02 Nov 2012