CompletedPhase 4

Treatment of Corneal Infiltrates Secondary to Epidemic Keratoconjunctivitis

Tunisia51 participantsStarted 2017-04-01

Plain-language summary

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.

Who can participate

Age range9 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Mean change from baseline in subepithelial infiltrates number

Timeframe: day 0, Month 1, Month 3, Month 6, Month 7

Mean change from baseline in Schirmer type 1 value

Timeframe: day 0, Month 1, Month 3, Month 6, Month 7

Trial details

NCT IDNCT04376970

SponsorMilitary Hospital of Tunis

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04-01

View on ClinicalTrials.gov More Adenoviral Keratoconjunctivitis trials