Treatment of Corneal Infiltrates Secondary to Epidemic Keratoconjunctivitis

Military Hospital of Tunis

Status and phase: Completed; Phase 4

Conditions: Adenoviral Keratoconjunctivitis

Treatments: Drug: FLUCON®; Drug: Cyclosporine A eye drops 0.5%

Study type: Interventional

Funder types: Other

Identifiers

NCT04376970

UR17DN02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 51 patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients having subepithelial infiltrates following epidemic keratoconjunctivites persisting for 14 days or more

Exclusion criteria

• a past history of glaucoma or other anterior or posterior segment disease or surgery
• a chronic use of topical or systemic medications
• pregnancy,
• contact lens wearers,
• patients who couldn't attend at least two regimen visits

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 2 patient groups

Fluorometholone group

Active Comparator group

Description:

This group included 38 patients treated with topical fluorometholone 0.1% (FLUCON®) 4 times a day for one month then 3 times a day for one month and 2 times a day for four months.

Treatment:

Drug: FLUCON®

Cyclosporine A group

Active Comparator group

Description:

This group included 34 patients treated with cyclosporine A 0.5% eye drops prepared in Ricin oil by the pharmacy of Tunis Military Hospital and prescribed 4 times a day for one month then 3 times a day for one month and 2 times a day for four months.

Treatment:

Drug: Cyclosporine A eye drops 0.5%