Adenoviral Keratoconjunctivitis Clinical Trial
Official title:
Treatment of Subepithelial Infiltrates Secondary to Epidemic Keratoconjunctivitis: Corticosteroids Versus Cyclosporine Eyedrops: A Randomized Double-blind Study
Purpose:
To compare efficiency and tolerance between topical 0.5% cyclosporine A and fluorometholone
in patients with subepithelial corneal infiltrates (SEIs).
Methods :
A prospective double-blind randomized study was conducted involving 72 eyes, 38 treated with
topical fluorometholone and 34 eyes treated with cyclosporine A 0.5% eyedrops, having SEIs.
Treatment was considered successful if there was reduction of SEIs and improvement in visual
acuity (two snellen lines). Tolerance was mainly evaluated by Schirmer test, conjunctival
hyperemia and burning sensation upon eyedrops instillation.
This study was performed on the 72 eyes of 51 patients who were referred to our clinics for
epidemic keratoconjunctivitis (EKC).Diagnosis of EKC was based on the constellation of
clinical features. The investigators conducted a double-blind randomized prospective parallel
trial involving : 38 patients treated with topical fluorometholone and 34 eyes treated with
cyclosporine A 0.5% eye drops. Cyclosporine A eye drops were prepared in Ricin oil by the
pharmacy of Tunis Military Hospital. The sample size was measured by our research department,
to obtain a conclusion of non-inferiority of cyclosporine A compared to fluorometholone in
the chronic phase of EKC.
Duration of the whole regimen was six months. The study included an extra month after the end
of the regimen. It was called " wash-out ". Patients who had less than one month of treatment
or an uncontrolled treatment side effect or who presented a degenerative iron line were
excluded from the rest of the regimen.The regimen was the same for both treatments in order
to preserve the double-blind characteristic : 4 times a day for one month then 3 times a day
for one month and 2 times a day for four months.
Patients were examined on admission to the study and one month , three months, six months and
seven months after the onset of treatment. The investigators followed a double-masked fashion
in all the phases of the study.
Information gathered in M0 included basic demographic information (age and sex), medical and
ophtalmological history, involved eye(s) and duration of symptoms in the acute episode. The
investigators evaluated and recorded the interval of time between the onset of the infection
and the beginning of the trial and called it " pretherapeutic period ". At each visit, SEIs
were photo-documented, best corrected visual acuity (converted to mean logarithm of the
minimum angle of resolution), spheric equivalent, SEIs number, intraocular pressure (with non
contact tonometers), break-up time and Schimer test type 1 and cup/disc score were recorded.
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