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

NCT03237936 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-04-18

Study results available
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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.

Conditions

  • Keratitis

Interventions

DRUG

1mg/mL ciclosporin

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

Sponsors & Collaborators

  • Santen SAS

    lead INDUSTRY

Principal Investigators

  • Pierre-Jean PISELLA · CHU Bretonneau

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-28
Primary Completion
2018-07-11
Completion
2018-07-11

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03237936 on ClinicalTrials.gov