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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03237936
Other study ID # NVG16E128
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 28, 2017
Est. completion date July 11, 2018

Study information

Verified date April 2024
Source Santen SAS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date July 11, 2018
Est. primary completion date July 11, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Patient eligibility is determined according to the following criteria: 1. In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements. 2. The patient signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures 3. Male or female patient is aged 18 years or above. 4. 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 5. Patient must be willing and able to undergo and return for scheduled study-related examinations. 6. The same eye (eligible eye) should fulfill all the above criteria. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
1mg/mL ciclosporin
IKERVIS® (1mg/ml ciclosporin) eye drops administered once daily following 3 months of treatment

Locations

Country Name City State
France CHU de Brest Brest

Sponsors (1)

Lead Sponsor Collaborator
Santen SAS

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation Between the Change From Baseline in VMR Measured With FVA System at Month 3 and the Change From Baseline in the CFS at Month 3. Spearman's coefficient of correlation will be calculated at Month 3 between the change from baseline of Corneal Fluorescein Staining (CFS) and respectively the change from baseline of Visual Maintenance Ratio (VRM). at month 3
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