Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis

Keratitis Clinical Trial

— FAST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03237936
• Other study ID #: NVG16E128
• Status: Completed
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratitis

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