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Efficacy and Safety of Ikervis Under Controlled Environmental Conditions Environment

NCT04492878 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-04-21

No results posted yet for this study

Summary

The proposed study is a prospective, open-label, unicentric, phase IV clinical trial.

This study is design to find new efficacy biomarkers for IKERVIS® (1mg/mL ciclosporin) eye drops after 1 and 3 month after initiation of therapy. Additionally, this study intends to investigate whether IKERVIS® will help patients to better overcome situations of desiccating stress by exposing them to an adverse controlled environment (ACE) and analyzing both clinical and molecular parameters.

Conditions

  • Dry Eye
  • Dry Eye Syndromes
  • Severe Keratitis

Interventions

DRUG

IKERVIS®1mg/mL

One drop of study medication once daily in each eye at bedtime during 90 days.

Sponsors & Collaborators

  • Santen Oy

    collaborator INDUSTRY

  • Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-04
Primary Completion
2021-01-18
Completion
2021-01-18

Countries

  • Spain

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 NCT04492878 on ClinicalTrials.gov