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Completed

NCT Number: NCT04376970

Treatment of Corneal Infiltrates Secondary to Epidemic Keratoconjunctivitis

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.

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Key information

Conditions

Adenoviral Keratoconjunctivitis Corneal Diseases Eye Diseases

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Military Hospital of Tunis

Tunis, Illinois, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FLUCON®

Drug

The drug was prescribed monthly according to the predefined regimen. It was not namely specefied in the prescription and was delivered by the hospital pharmacy according to the randomisation list.The subjects were masked to the contents and were instructed to return the empty tubes on monthly visit, wherein 1 pack of topical treatment was provided to them. Neither the patient nor the ophthalmologist knew the allocated treatment. No other medication was allowed during the trial. 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.

Other names: Fluorometholone

Cyclosporine A eye drops 0.5%

Drug

The same regimen was prescribed for both treatments in order to preserve the double-blind characteristic. Cyclosporine eye drops 0.5%, was prepared from an oral solution of cyclosporine (Sandimmun®) and combined with castor oil, both sterilized by filtration. The preparation was carried out in a pharmacotechnical laboratory where a controlled atmosphere area was dedicated to ophthalmic preparations. The castor oil-Sandimmun® solution mixture is made in a sterile receptacle. After stirring, the mixture is distributed into sterile low density polyethylene bottles. A sterile insert and cap including a tamper-evident seal were placed on each bottle. A content control was then carried out on each batch produced. A sterility test was done on a batch of each day of preparation. Each bottle of each batch is then cleaned, polished, labeled and then packaged in a pre-printed box with an adapted notice. The stability was fixed at 6 months before opening and at 15 days after opening.

Other names: CsA

Primary outcomes

  1. Mean change from baseline in subepithelial infiltrates number

    Time frame: day 0, Month 1, Month 3, Month 6, Month 7

    The subepithelial infiltrates were counted at baseline and at each control visit.The mean change was then calculated between each two visits. Treatment was considrerd efficient if the subepithelial infiltrates decreased half the baseline number or completely disappeared.

  2. Mean change from baseline in Schirmer type 1 value

    Time frame: day 0, Month 1, Month 3, Month 6, Month 7

    The Schirmer value was assessed without local anesthesia. Treatment was considered efficient with a good tolerance when the schirmer type 1 was superior than 5ml/5min.

Secondary outcomes

  1. Mean change from baseline in best corrected visual acuity

    Time frame: day 0, Month 1, Month 3, Month 6

    A gain of two snellen lines from baseline was considered a mark of treatment efficiency.

  2. Mean change from baseline in spheric equivalent

    Time frame: day 0, Month 6

    Spheric equivalent was calculated using an automatic refraction. An increase from baseline of 0.25 dioptries was considered a mark of treatment efficiency.

  3. Mean change from baseline in clinical score

    Time frame: day 0, Month 1, Month 3, Month 6

    These subjective variables : (1) photophobia; (2) Foreign body sensation ; (3) Visual blurring ; (4) tearing and (5) ocular pain were evaluated according to their severity (0 indicated no ; 1, mild ; and 2, severe). The sum of these variables was calculated for each visit and called clinical score.

  4. Overall satisfaction with treatment subjective evaluation: scale

    Time frame: Month 7

    For subjective evaluation of the treatment, patients were asked to evaluate in the seventh month their overall satisfaction with treatment on a scale of 0-10. 0 means no satisfaction with the treatment and 10 means an excellent satisfaction with the treatment.

  5. Number of participants with burning sensation upon eyedrops instillation

    Time frame: day 0, Month 1, Month 3, Month 6

    Burning sensation upon eyedrops instillation was considered as a treatment intolerance mark.

  6. Mean change from baseline in intraocular pressure

    Time frame: day 0, Month 1, Month 3, Month 6

    Intraocular pressure was measured with with non contact tonometers. An increase of 6 mmHg from baseline value was defined as a steroid-induced glaucoma.

  7. Number of participants with appearance of lens opacification and corneal ulcer or superinfection

    Time frame: up to six months

    Lens opacification and corneal ulcer or superinfection were considered as a mark of corticosteroid intolerance.

Sponsors and collaborators

Lead sponsor

Military Hospital of Tunis

Other

Registry information

Official study title

Treatment of Subepithelial Infiltrates Secondary to Epidemic Keratoconjunctivitis: Corticosteroids Versus Cyclosporine Eyedrops: A Randomized Double-blind Study

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 6, 2020
Registry last updated
May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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