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Evaluation of the Efficacy and Safety of Tacrolimus Drops in Children With Vernal Keratoconjunctivitis

NCT05076084 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2021-11-17

No results posted yet for this study

Summary

Non-interventional single-center cohort study (Rothschild Foundation Hospital) of patients aged 0 to 18 years followed up in ophthalmology for KCV, treated with tacrolimus 0.1% eye drops previously treated with ciclosporin 2% with treatment failure.

1. Prospective collection of quality of life from the parents and/or, if possible, the children via the QUICK questionnaire and 6 additional questions
2. Retrospective collection of clinical data (secondary endpoints) from the patients' medical records, aiming to compare the period before the start of treatment and the period under treatment with TALYMUS

The objective of this study is to evaluate the response to TALYMUS® treatment in patients with Vernal keratoconjunctivitis who have failed ciclosporin 2% therapy, whether due to lack of efficacy, compliance difficulties or poor tolerance.

Conditions

  • Vernal Keratoconjunctivitis

Interventions

PROCEDURE

QUICK questionnaire and 6 additional questions

QUICK questionnaire and 6 additional questions

OTHER

Retrospective collection of clinical data from the patients' medical records

Retrospective collection of clinical data from the patients' medical records

Sponsors & Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

    lead NETWORK

Principal Investigators

  • Rebecca Rebecca · Hôpital Fondation A. de Rothschild

  • Gilles MARTIN · Hôpital Fondation A. de Rothschild

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-19
Primary Completion
2021-10-25
Completion
2021-11-10

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 NCT05076084 on ClinicalTrials.gov