Clinical trial NCT04376970: Treatment of Corneal Infiltrates Secondary to Epidemic Keratoconjunctivitis
Official title: Treatment of Subepithelial Infiltrates Secondary to Epidemic Keratoconjunctivitis: Corticosteroids Versus Cyclosporine Eyedrops: A Randomized Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adenoviral Keratoconjunctivitis
Keywords: adenoviral keratoconjunctivitis
corticosteroid
cyclosporine
cornea
subepithelial infiltrates
Lead sponsor: Military Hospital of Tunis
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 51
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean change from baseline in subepithelial infiltrates number
timeFrame: day 0, Month 1, Month 3, Month 6, Month 7
measure: Mean change from baseline in Schirmer type 1 value
timeFrame: day 0, Month 1, Month 3, Month 6, Month 7
Secondary outcomes:
measure: Mean change from baseline in best corrected visual acuity
timeFrame: day 0, Month 1, Month 3, Month 6
measure: Mean change from baseline in spheric equivalent
timeFrame: day 0, Month 6
measure: Mean change from baseline in clinical score
timeFrame: day 0, Month 1, Month 3, Month 6
measure: Overall satisfaction with treatment subjective evaluation: scale
timeFrame: Month 7
measure: Number of participants with burning sensation upon eyedrops instillation
timeFrame: day 0, Month 1, Month 3, Month 6
measure: Mean change from baseline in intraocular pressure
timeFrame: day 0, Month 1, Month 3, Month 6
measure: Number of participants with appearance of lens opacification and corneal ulcer or superinfection
timeFrame: up to six months
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Military Hospital of Tunis
state: Illinois
Study officials:
affiliation: Military Hospital of Tunis
name: Afef Maalej
role: STUDY_DIRECTOR
References:
citation: Levinger E, Slomovic A, Sansanayudh W, Bahar I, Slomovic AR. Topical treatment with 1% cyclosporine for subepithelial infiltrates secondary to adenoviral keratoconjunctivitis. Cornea. 2010 Jun;29(6):638-40. doi: 10.1097/ICO.0b013e3181c33034.
citation: Maychuk DY, Vasil'eva OA, Russu LI, Mezentseva MV. [Clinical and immunological comparisons of therapeutic regimens for corneal infiltrates secondary to adenoviral keratoconjunctivitis]. Vestn Oftalmol. 2015 Jul-Aug;131(4):49-55. doi: 10.17116/oftalma2015131449-55. Russian.
citation: Reinhard T, Godehardt E, Pfahl HG, Sundmacher R. [Local cyclosporin A in nummuli after keratoconjunctivitis epidemica. A pilot study]. Ophthalmologe. 2000 Nov;97(11):764-8. doi: 10.1007/s003470070025. German.
citation: Aydin Kurna S, Altun A, Oflaz A, Karatay Arsan A. Evaluation of the impact of persistent subepithelial corneal infiltrations on the visual performance and corneal optical quality after epidemic keratoconjunctivitis. Acta Ophthalmol. 2015 Jun;93(4):377-82. doi: 10.1111/aos.12496. Epub 2014 Jul 6.
citation: Gouider D, Khallouli A, Maalej A, Yousfi MA, Ksiaa I, Bouguerra C, Ajili F, Khairallah M. Corticosteroids Versus Cyclosporine for Subepithelial Infiltrates Secondary to Epidemic Keratoconjunctivitis: A Prospective Randomized Double-Blind Study. Cornea. 2021 Jun 1;40(6):726-732. doi: 10.1097/ICO.0000000000002589.