Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis
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|ClinicalTrials.gov Identifier: NCT03237936|
Recruitment Status : Unknown
Verified October 2017 by Santen SAS.
Recruitment status was: Recruiting
First Posted : August 3, 2017
Last Update Posted : October 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Keratitis||Drug: 1mg/mL ciclosporin||Phase 4|
In this phase IV clinical trial the Month 3 visit assessments will be used to assess the efficacy (quality of vision and other parameters) and safety of IKERVIS® in DED patients with severe keratitis.
To assess the effect on the quality of vision of IKERVIS® (1mg/ml ciclosporin) eye drops administered once daily in adult dry eye disease (DED) patients with severe keratitis over 3 months of treatment.
To assess the safety of DED patients with severe keratitis treated with IKERVIS® (1mg/mL ciclosporin) for 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||March 28, 2017|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
Experimental: IKERVIS® (1mg/mL ciclosporin) eye drops
one drop of study medication (IKERVIS®1mg/mL) once daily in each eye at bedtime during 3 months.
Drug: 1mg/mL ciclosporin
IKERVIS® (1mg/ml ciclosporin) eye drops administered once daily following 3 months of treatment
Other Name: IKERVIS®
- Correlation between the change from baseline in quality of vision and the change from baseline in Corneal Fluorescein Staining (CFS) [ Time Frame: at month 3 ]CFS test can detect damage to the cornea.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237936
|Contact: Elsa LLOBET-MERKLINGfirstname.lastname@example.org|
|CHU de Brest||Recruiting|
|Contact: Béatrice COCHENER, MD|
|Principal Investigator: Pierre-Jean PISELLA, MD|
|Principal Investigator:||Pierre-Jean PISELLA||CHU Bretonneau|