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

NCT05076084 | Completed

• 1 other identifier: RGR_2021_21
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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

Conditions

Vernal Keratoconjunctivitis

Keywords

Vernal keratoconjunctivitis; Tacrolimus

Outcome Measures

Primary Outcomes (1)

• Quality of life with TALYMUS® ophthalmic solution versus ciclosporin 2% ophthalmic solution

  Score distribution of the QUICK questionnaire with TALYMUS® ophthalmic solution versus ciclosporin 2% ophthalmic solution in children with vernal keratoconjunctivitis treated with TALYMUS® ophthalmic solution due to ciclosporin 2% failure

  Day 1

Study Arms (1)

Patients aged 0 to 18 years followed for Vernal keratoconjunctivitis

Treated (or having been treated) with tacrolimus 0.1% ophthalmic solution previously treated with ciclosporin 2% ophthalmic solution with treatment failure.

Procedure: QUICK questionnaire and 6 additional questions; Other: Retrospective collection of clinical data from the patients' medical records

Interventions

QUICK questionnaire and 6 additional questions PROCEDURE

QUICK questionnaire and 6 additional questions

Patients aged 0 to 18 years followed for Vernal keratoconjunctivitis

Retrospective collection of clinical data from the patients' medical records OTHER

Retrospective collection of clinical data from the patients' medical records

Patients aged 0 to 18 years followed for Vernal keratoconjunctivitis

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with vernal keratoconjunctivitis, treated (or having been treated) with tacrolimus 0.1% ophthalmic solution previously treated with ciclosporin 2% ophthalmic solution with treatment failure.

You may qualify if:

• Patients followed in ophthalmology for vernal keratoconjunctivitis .
• Treated (or having been treated) with tacrolimus 0.1% ophthalmic solution previously treated with ciclosporin 2% ophthalmic solution with treatment failure.

You may not qualify if:

• Parental opposition

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hôpital Fondation A. de Rothschuld

Paris, 75019, France

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Rebecca Rebecca

  Hôpital Fondation A. de Rothschild

  PRINCIPAL INVESTIGATOR

• Gilles MARTIN

  Hôpital Fondation A. de Rothschild

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 13, 2021
• Study Start: October 19, 2021
• Primary Completion: October 25, 2021
• Study Completion: November 10, 2021
• Last Updated: November 17, 2021

Record last verified: 2021-11

Locations

FR (1)