EUCTR2017-004929-33-AT
Active, not recruiting
Phase 1
Effect of Ciclosporin eyedrops on ocular symptoms and optical image quality in patients with primary or secondary Sjögren syndrome
KH Hietzing, Department of Ophthalmology0 sites20 target enrollmentNovember 27, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- primary or secondary Sjögren Syndrome
- Sponsor
- KH Hietzing, Department of Ophthalmology
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Diagnosis of severe keratoconjunctivitis sicca defined by:
- •1\) Staining of the cornea \= Grade III according to the Oxford scale
- •2\) OSDI value \= 12
- •\- Age between 18 and 90 years
- •\- Primary or secondary Sjögren syndrome (defined according to the American\-European Consensus Group criteria)
- •\- Stable course of the underlying rheumatic disease and unchanged systemic treatment for 6 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 15
Exclusion Criteria
- •\- Pregnancy
- •\- Children and adolescents up to the age of 18
- •\- Eye surgery in the last 6 months
- •\- Simultaneous participation in another study
- •\- Regular use of eye drops except for tear substitutes
- •\- Use of Ciclosporin\-containing or Corticosteroid\-containing eye drops in the last 6 months
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 2
A study to evaluate the effect of cyclosporine 2% eye drop on surgical result of glaucoma surgery (trabeculectomy)glaucoma.Primary Open-Angle GlaucomaIRCT138706111154N1Vice Chancellor for Research, Mashhad University of Medical Sciences40
Completed
Not Applicable
Effect of Ciclosporin Eyedrops on Sjögren SyndromeDry Eye SyndromesNCT04597762Hospital Hietzing12
Recruiting
Not Applicable
Treatment efficacy of 0.05% cyclosporine eyedrop on ocular surface changes after anti-glaucoma medication in glaucoma patients.Diseases of the eye and adnexaKCT0007124Keimyung University Dongsan Hospital30
Recruiting
Phase 4
The Effect of 0.05% CsA Eye Drops on Post-refractive Surgery Dry EyeDry EyeNCT06043908Peking University Third Hospital60
Completed
Phase 3
Cyclosporin A Eye Drop Treatment in Vernal KeratoconjunctivitisVernal KeratoconjunctivitisNCT00426023Campus Bio-Medico University48