Topical cyclosporine A 0.05% in the treatment of keratoconjunctivitis sicca

Not Applicable

• Conditions: H16.2; H04.1; Keratoconjunctivitis; Other disorders of lacrimal gland

• Registration Number: DRKS00003269
• Lead Sponsor: niversitätsklinikum Erlangen der Friedrich-Alexander Universität Erlangen-Nürnberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2009-11-16
• Study Start: 2011-10-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

patients with severe keratoconjunctivitis sicca (Dry Eye Severity Level 3, Dry eye severity grading scheme, DEWS 2007); age between 18 and 75 years; education and written consent; severe symptoms; positive staining in fluorescein and rose bengal staining

Exclusion Criteria

pregnancy; breast feeding mothers; other ocular diseases that demand other topical medicatios (anti-glaucoma eye drops); lidanomalies; insufficiency of eyelid closure; ocular surgery within the previous 3 months, especially after refractive surgery or cataract surgery; wearing of contact lenses; systemic or topical application of corticosteroids; uveitis anterior; ocular pemphigoid; Stevens-Johnson-Syndrome; ocular burns; no compliance; underaged patients; written consent not possible

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
after 3 months treatment:<br><br>standardized questionnaire for clinical diagnosis features:<br><br>LIPCOF; tear break-up time (BUT); <br>fluorescein and rose bengal staining; basal secretion of the tear film (Jones test);<br>intraocular pressure (IOP);<br>Ocular Surface Disease Index (OSDI-Score): quality of life questionnaire; profile of cytokines in the tear fluid

Secondary Outcome Measures

Name	Time	Method
to be omitted