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A Randomized Study of the Efficacy and Safety of 0.1% Cyclosporine a Cationic Emulsion in Treatment of Moderate to Severe Dry Eye
- Source :
- European Journal of Ophthalmology
- Publication Year :
- 2017
- Publisher :
- SAGE Publications, 2017.
-
Abstract
- Purpose The SICCANOVE study aimed to compare the efficacy and safety of 0.1% cyclosporine A cationic emulsion (CsA CE) versus vehicle in patients with moderate to severe dry eye disease (DED). Methods In this multicenter, double-masked, parallel-group, controlled study, patients were randomized (1:1) to receive CsA CE (Ikervis®) or vehicle for 6 months. The co-primary efficacy endpoints at month 6 were mean change from baseline in corneal fluorescein staining (CFS; modified Oxford scale) and in global ocular discomfort (visual analogue scale [VAS]). Results The mean change in CFS from baseline to month 6 (CsA CE: n = 241; vehicle: n = 248) was significantly greater with CsA CE than with vehicle (-1.05 ± 0.98 and -0.82 ± 0.94, respectively; p = 0.009). Ocular discomfort improved similarly in both groups; however, the percentage of patients with ≥25% improvement in VAS was significantly higher with CsA CE (50.2%) than with vehicle (41.9%; p = 0.048). In a post hoc analysis of patients with severe ocular surface damage (CFS score 4) at baseline (CsA CE: n = 43; vehicle: n = 42), the percentage of patients with improvements of ≥2 grades in CFS score and ≥30% in Ocular Surface Disease Index score was significantly greater with CsA CE (p = 0.003). Treatment compliance and ocular tolerability were satisfactory and as expected for CsA use. Conclusion Cyclosporine A CE was well-tolerated and effectively improved signs and symptoms in patients with moderate to severe DED over 6 months, especially in patients with severe disease, who are at risk of irreversible corneal damage.
- Subjects :
- Adult
Male
medicine.medical_specialty
Visual analogue scale
Dry Eye Syndromes
Severity of Illness Index
law.invention
03 medical and health sciences
Young Adult
0302 clinical medicine
Randomized controlled trial
Double-Blind Method
law
Ophthalmology
Severity of illness
Post-hoc analysis
medicine
Humans
Ocular Surface Disease Index
Original Research Article
Dry eye disease
Cationic emulsion
Aged
Aged, 80 and over
Dose-Response Relationship, Drug
business.industry
Severe keratitis
General Medicine
Middle Aged
CsA
Dose–response relationship
Treatment Outcome
Tolerability
Anesthesia
030221 ophthalmology & optometry
Cyclosporine
Emulsions
Female
Ophthalmic Solutions
business
030217 neurology & neurosurgery
Immunosuppressive Agents
Follow-Up Studies
Subjects
Details
- Language :
- English
- ISSN :
- 17246016 and 11206721
- Volume :
- 27
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- European Journal of Ophthalmology
- Accession number :
- edsair.doi.dedup.....2d2db5a8326ece16a32ea6cdd5a9bbe5