NCT02987686|CompletedPhase 1DMC
Topical Infliximab for Sterile Corneal Melt
Topical Infliximab for the Treatment of Sterile Corneal Melt
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Sponsor study identifier
interventional
7
1 country
1
Study Start
September 6, 2017
Actual (reported)Primary Completion
November 15, 2025
Actual (reported)Study Completion
November 15, 2025
Actual (reported)Corneal melt is a complication that could affect very ill eyes and lead to the thinning of the cornea (the clear window covering of the eyes). This thinning can lead to severe consequences such as the leakage of the liquid inside the eye (ocular perforation), or even blindness. Corneal melt can be caused by certain infections or as a sterile process. This project only includes patients with a sterile corneal melt (without an infection) caused by diseases such as rosacea, Sjogren's syndrome, rheumatoid arthritis, Crohn's disease, Stevens Johnson syndrome, as well as toxic epidermal necrolysis or mucous membrane pemphigoid. Infliximab is an antibody against tumour necrosis factor alpha and has been used to treat or prevent corneal melt in certain patients with inflammatory of auto-immune disease. In this situation, infliximab was used intravenous (using veins) in order to treat the whole body. This study's hypothesis is that infliximab can safely be used as eye drops for the treatment of sterile corneal melt.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 15, 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 26, 2016
Actual (reported)December 9, 2016
Actual (reported)September 6, 2017
Actual (reported)November 15, 2025
Actual (reported)November 15, 2025
Actual (reported)Adverse Events
Number and type of adverse events
12 weeks
Percentage of patients finishing 4 weeks of infliximab use
Percentage of patients finishing 4 weeks of infliximab use
4 weeks
Visual Acuity
4 and 12 weeks
Ocular surface symptoms as assessed by ocular disease index score
4 and 12 weeks
Conjunctival hyperemia using a slit-lamp photographs
4 and 12 weeks
Corneal thickness as measured by anterior segment optical coherence tomography
4 weeks
Surface area of the corneal melt using a slit-lamp photographs
4 weeks
Additionally to standard treatment, patients with all inclusive criteria and none exclusive criteria will be included in the therapeutic group and will receive topical infliximab QID for 4 weeks.
Patients with all inclusive criteria and one exclusive criteria will receive the standard treatment, without topical infliximab.
Aside from the standard treatment, patients will receive topical infliximab ( 10mg/ml) four (4) time per day for four (4) weeks.
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X3E4, Canada
Marie-Claude Robert, MD
Centre hospitalier de l'Université de Montréal (CHUM)
7 participants (actual enrollment reported by the registry).
First Submitted
October 26, 2016
First Posted
December 9, 2016
Study Start
September 6, 2017
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
November 15, 2025
Actual (reported)Study Completion
November 15, 2025
Actual (reported)Last Updated
April 28, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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