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Efficacy and safety of 0.1% ciclosporin A cationic emulsion in dry eye disease: A pooled analysis of two double-masked, randomised, vehicle-controlled phase III clinical studies
- Source :
- The British Journal of Ophthalmology
- Publication Year :
- 2019
- Publisher :
- BMJ Publishing Group, 2019.
-
Abstract
- Background/aimTo assess the treatment effect of 0.1% ciclosporin A cationic emulsion (CsA CE) versus vehicle on signs/symptoms of dry eye disease (DED) in various subgroups (moderate-to-severe DED/severe DED/Sjögren’s syndrome (SS)/SS with severe DED).MethodsPooled data were analysed from two similar phase III studies: SICCANOVE (moderate-to-severe DED) and SANSIKA (severe DED with severe keratitis). In both studies, patients aged ≥18 years received CsA CE 0.1% (n=395) or vehicle (n=339) once daily for 6 months. A composite responder efficacy endpoint (corneal fluorescein staining–Ocular Surface Disease Index (CFS–OSDI) at month 6) was used to evaluate the efficacy of CsA CE in alleviating signs/symptoms of DED (response defined as improvement of ≥2 grades in CFS and ≥30% in OSDI (baseline to month 6)). Human leucocyte antigen-DR (HLA-DR) conjunctival expression was used as a biomarker of ocular surface inflammation.ResultsCsA CE–treated patients were significantly more likely to be CFS–OSDI responders than vehicle-treated patients in the overall (OR 1.66, 95% CI 1.11 to 2.50; P=0.015), severe DED (1.80, 1.04 to 3.19; P=0.038) and SS with severe DED (3.37, 1.20 to 11.19; P=0.030) populations. The difference was not significant for CsA CE versus vehicle for the overall Sjögren’s population (OR 1.77, CI 0.89 to 3.66; P=0.109). CsA CE also significantly reduced median HLA-DR expression versus vehicle at 6 months (P=0.002).ConclusionPooled phase III data indicate CsA CE produced significant improvement in signs/symptoms versus vehicle in patients with moderate-to-severe DED (especially in those with severe keratitis), including patients with SS with severe DED.
- Subjects :
- Male
medicine.medical_specialty
Population
Visual Acuity
Disease
Gastroenterology
Keratitis
03 medical and health sciences
Cellular and Molecular Neuroscience
0302 clinical medicine
Double-Blind Method
Internal medicine
ocular surface
tears
treatment medical
Ophthalmology
Sensory Systems
medicine
Humans
Pooled data
In patient
education
Aged
education.field_of_study
business.industry
Clinical Science
Middle Aged
medicine.disease
Ciclosporin
Pooled analysis
Logistic Models
030221 ophthalmology & optometry
Cyclosporine
Biomarker (medicine)
Dry Eye Syndromes
Female
Ophthalmic Solutions
business
030217 neurology & neurosurgery
Immunosuppressive Agents
medicine.drug
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- The British Journal of Ophthalmology
- Accession number :
- edsair.doi.dedup.....528b7068782889607b7fbac964227a98