At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 17 enrolled
Drug / intervention
1mg/mL ciclosporindrug
Likely dose
1mg/mL ciclosporinfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IV, Prospective, Open-label, Multicentre, Single Arm, 3-month Proof of Concept Study to Assess the Effect of IKERVIS® Eye Drops Administered Once Daily on the Quality of Vision in Dry Eye Disease (DED) Patients With Severe Keratitis
In Brief
A Phase 4 clinical trial evaluating 1mg/mL ciclosporin for Keratitis. Completed, enrolled 17 participants across 1 site.
Detailed Summary
The proposed 3-month study is a prospective, open-label, multicentre, phase IV, proof of concept study. The study is designed to assess the effect on the quality of vision of IKERVIS® (1mg/mL ciclosporin) eye drops administered once daily in dry eye disease (DED) patients with severe keratitis, as well as its safety and efficacy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKeratitis
CountriesFrance
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartMar 2017
First PostedAug 2017
Primary CompletionJul 2018
TodayJul 2026
First PostedAug 3, 2017
Enrollment StartMar 28, 2017
Primary CompletionJul 11, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 8.9 years ago
Interventions
1mg/mL ciclosporindrug
IKERVIS® (1mg/ml ciclosporin) eye drops administered once daily following 3 months of treatment