Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05076084 |
| Other study ID # |
RGR_2021_21 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 19, 2021 |
| Est. completion date |
November 10, 2021 |
Study information
| Verified date |
November 2021 |
| Source |
Fondation Ophtalmologique Adolphe de Rothschild |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Vernal keratoconjunctivitis (VKC) is a chronic inflammatory eye disease affecting children
and adolescents. It is a disease of allergic origin which, if left untreated, can have a
significant impact on quality of life, daily activities and learning. In some cases, sequelae
of the disease or complications from the treatments used can lead to permanent vision
impairment.
Symptoms of VKC include intense itching, tearing, mucous secretions, burning, foreign body
sensation and severe photophobia. Clinical signs include conjunctival and corneal involvement
-which may leave scarring opacities-and in the most severe stage, limbal insufficiency with
definitive corneal conjunctivalization.
There is no consensus on the therapeutic strategy to adopt. Treatment is based on a
combination of antihistamines and mast cell stabilizers, and in case of failure on
corticosteroids. Cortico-resistant or cortico-dependent forms require treatment with local or
general immunosuppressants, because of the long-term ocular complications of corticosteroids.
These local immunosuppressants, belonging to the class of calcineurin inhibitors, have been
used in ophthalmology for many years in hospital preparations of ciclosporin eye drops. More
recently, commercial forms have appeared on the market: RESTASIS® (0.05% cyclosporine eye
drops), IKERVIS® and VERKAZIA® (0.1% cyclosporine eye drops), CICLOGRAFT® (2% cyclosporine
eye drops) and TALYMUS® (0.1% tacrolimus eye drops).
Although TALYMUS® has French marketing authorization for VKC, its place in the therapeutic
strategy and its positioning in relation to the various cyclosporine eye drops is not clearly
established. Series have reported similar efficacy of TALYMUS® and 0.05% and 2% cyclosporine
in patients with KCV, at a lower dosage than those usually required for cyclosporine eye
drops (2 drops per day for TALYMUS® versus 3 to 4 drops per day for cyclosporine). Given the
difficulties of compliance in children, particularly in a school environment and in the
context of a chronic pathology, the possibility of a less frequent administration represents
a significant advantage. The simplicity of use and efficacy of TALYMUS® , as well as its
safety profile, which is comparable to that of cyclosporine eye drops, have led some authors
to recommend it as a first-line eye drop on a par with cyclosporine.
In addition, in numerous publications and in our experience, there are cases of failure of
treatment with cyclosporine eye drops, which have even led some authors to recommend for many
years only hospital preparations of cyclosporine at concentrations greater than or equal to
1%. It is therefore to be expected that cases of resistance to VERKAZIA® will appear.
One study reported the efficacy of a 0.1% tacrolimus hospital preparation in patients who had
failed 1% cyclosporine therapy. However, the efficacy of TALYMUS® treatment in patients who
have failed ciclosporin 2% therapy has not been reported to date.
