Phase 3
N=176
Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis
Atopic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT00884585 ↗Enrolled (actual)
176
Serious AEs
5.4%
Results posted
Nov 2012
Primary outcome: Primary: Percentage of Treatment Responders — 21.3; 17.2 Percentage of Patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cyclosporine Vehicle (Drug); Cyclosporine 0.010% (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Treatment Responders |
21.3; 17.2 | — |
| SECONDARY Percentage of Punctate Corneal Staining Responders |
24.7; 23.0 | — |
| SECONDARY Percentage of Patients With an Improvement in the Composite Symptom Score |
30.3; 28.7 | — |
| SECONDARY Percentage of Patients With an Improvement in the Punctate Corneal Staining Score |
42.7; 42.5 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00884585). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.