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

NCT ID: NCT03237936

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-28
• Study Completion Date: 2018-07-11

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.

Conditions

Keratitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IKERVIS® (1mg/mL ciclosporin) eye drops

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

Group Type: EXPERIMENTAL

1mg/mL ciclosporin

Intervention Type: DRUG

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

Interventions

1mg/mL ciclosporin

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

Intervention Type: DRUG

Other Intervention Names

IKERVIS®

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Santen SAS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre-Jean PISELLA

Role: PRINCIPAL_INVESTIGATOR

CHU Bretonneau

Locations

CHU de Brest

Brest, , France

Countries

France

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NVG16E128

Identifier Type: -

Identifier Source: org_study_id