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

Phase 4

Completed

• Conditions: Keratitis
• Interventions: Drug: 1mg/mL ciclosporin

• Registration Number: NCT03237936
• Lead Sponsor: Santen SAS

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 ciclosporin) eye drops administered once daily in dry eye disease (DED) patients with severe keratitis, as well as its safety and efficacy.

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.

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 Timeline

• Study First Submitted: 2017-01-13
• Study Start: 2017-03-28
• Study First Submitted QC: 2017-07-31
• Study First Posted: 2017-08-03
• Primary Completion: 2018-07-11
• Study Completion: 2018-07-11
• Results First Submitted: 2023-10-04
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-16
• Last Update Submitted: 2024-04-16
• Results First Posted: 2024-04-18
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IKERVIS® (1mg/mL ciclosporin) eye drops	1mg/mL ciclosporin	one drop of study medication (IKERVIS®1mg/mL) once daily in each eye at bedtime during 3 months.

Primary Outcome Measures

Name	Time	Method
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.	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).

Trial Locations

Locations (1)

CHU de Brest; 🇫🇷 Brest, France