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

Sponsor
Santen SAS (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03237936
Collaborator
(none)
33
Enrollment
1
Location
1
Arm
15.1
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 1mg/mL ciclosporin
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
33 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 28, 2017
Anticipated Primary Completion Date :
Jul 1, 2018
Anticipated Study Completion Date :
Jul 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: IKERVIS® (1mg/mL ciclosporin) eye drops

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between the change from baseline in quality of vision and the change from baseline in Corneal Fluorescein Staining (CFS) [at month 3]

      CFS test can detect damage to the cornea.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. Patient must be willing and able to undergo and return for scheduled study-related examinations.

    2. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Brest Brest France

    Sponsors and Collaborators

    • Santen SAS

    Investigators

    • Principal Investigator: Pierre-Jean PISELLA, CHU Bretonneau

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Santen SAS
    ClinicalTrials.gov Identifier:
    NCT03237936
    Other Study ID Numbers:
    • NVG16E128
    First Posted:
    Aug 3, 2017
    Last Update Posted:
    Oct 11, 2017
    Last Verified:
    Oct 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Eye Diseases
    Keratitis
    Cyclosporine
    Cyclosporins

    Study Results

    No Results Posted as of Oct 11, 2017