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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03237936
Recruitment Status : Unknown
Verified October 2017 by Santen SAS.
Recruitment status was:  Recruiting
First Posted : August 3, 2017
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Keratitis 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 28, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

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 Name: IKERVIS®




Primary Outcome Measures :
  1. Correlation between the change from baseline in quality of vision and the change from baseline in Corneal Fluorescein Staining (CFS) [ Time Frame: at month 3 ]
    CFS test can detect damage to the cornea.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237936


Contacts
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Contact: Elsa LLOBET-MERKLING 0613861174 e.llobetmerkling@euraxipharma.fr

Locations
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France
CHU de Brest Recruiting
Brest, France
Contact: Béatrice COCHENER, MD         
Principal Investigator: Pierre-Jean PISELLA, MD         
Sponsors and Collaborators
Santen SAS
Investigators
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Principal Investigator: Pierre-Jean PISELLA CHU Bretonneau
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Responsible Party: Santen SAS
ClinicalTrials.gov Identifier: NCT03237936    
Other Study ID Numbers: NVG16E128
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eye Diseases
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratitis
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Cyclosporine
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors