Topical cyclosporine A 0.05% in the treatment of keratoconjunctivitis sicca

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00003269

Enrollment

Registered

2011-10-04

Start date

2007-01-15

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H16.2 H04.1

Interventions

Group 1: preservative-free hyaluronic acid artificial tears one drop 5 times per day and one drop of cyclosporine A 0.05% twice a day over a time period of 3 months in both eyes Group 2: preservative-

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
to be omitted	—

Countries

Germany

Contacts

Public ContactChristina Jacobi

Augenklinik des Universitätsklinikums Erlangen

christina.jacobi@uk-erlangen.de09131 8544712

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026