Status:
COMPLETED
Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis
Lead Sponsor:
Santen SAS
Conditions:
Keratitis
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief 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 ciclospo...
Detailed Description
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....
Eligibility Criteria
Inclusion
- Patient eligibility is determined according to the following criteria:
- In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements.
- The patient signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures
- Male or female patient is aged 18 years or above.
- DED patients with persistent severe keratitis at the Screening and
- Baseline Visits defined as the following:
- • CFS score of 3, 4 or 5 on the modified Oxford scale
- Patient must be willing and able to undergo and return for scheduled study-related examinations.
- The same eye (eligible eye) should fulfill all the above criteria.
Exclusion
- Patients with history of ocular trauma or ocular infection (viral, bacterial, fungal, protozoal) within 90 days before the Screening Visit and any ocular diseases other than dry eye disease requiring topical ocular treatment during the course of the study.
Key Trial Info
Start Date :
March 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2018
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03237936
Start Date
March 28 2017
End Date
July 11 2018
Last Update
April 18 2024
Active Locations (1)
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1
CHU de Brest
Brest, France