N/A
N=781
Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease
Keratoconjunctivitis Sicca
Bottom Line
View on ClinicalTrials.gov: NCT00717418 ↗Enrolled (actual)
781
Serious AEs
—
Results posted
Jan 2012
Primary outcome: Primary: Ocular Surface Disease Index (OSDI) Total Score at Baseline — 40.3 Scores on a Scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- cyclosporine ophthalmic emulsion 0.05%, artificial tears (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Aug 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Surface Disease Index (OSDI) Total Score at Baseline |
40.3 | — |
Summary
This study will evaluate the efficacy of cyclosporine ophthalmic solution vs. other non-prescription treatments in patients with dry eye disease. Patient and physician assessments completed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of dry eye disease
- Currently using artificial tears daily
- Male or female of legal age of consent
- Normal lid position and closure
Exclusion Criteria
- Patients currently using cyclosporine ophthalmic emulsion 0.05%
- Participation in other investigational drug or device study
- Any current or previous topical ophthalmic or oral cyclosporine use within the last three years
Data sourced from ClinicalTrials.gov (NCT00717418). 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.