This study is a prospective, multicentre, parallel-group, active-controlled, non-inferiority study conducted in adult patients with moderate-to-severe dry eye disease (DED) related to keratitis or keratoconjunctivitis. This study is to be conducted in France, Poland and Spain. The patients will be randomised to receive Cationorm Pro® or the reference treatment, VISMED® (ratio 1:1) in an investigator-masked fashion
Primary: • To compare the ocular efficacy of Cationorm Pro® with that of VISMED® in patients with moderate to severe DED related to keratitis or keratoconjunctivitis after a 4-week treatment period (Day 28). Secondary: To compare the ocular efficacy of Cationorm Pro® with that of VISMED® in patients with moderate to severe DED related to keratitis or keratoconjunctivitis over a 12-week treatment period To evaluate the ocular tolerability and safety of Cationorm Pro® versus VISMED® in patients with moderate to severe DED related to keratitis or keratoconjunctivitis throughout the duration of treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
83
Eye Drops
Eye Drops
CHRU Bretonneau
Tours, France
Gabinet Okulistyczny
Bielsko-Biala, Poland
5th MILITARY CLINICAL HOSPITAL IN KRAKOW
Krakow, Poland
Szpital SW. Rozy
Krakow, Poland
Change of ocular surface staining (OSS) score between baseline and Day 28.
The primary endpoint of the study is the difference between patients treated with Cationorm Pro® and patients treated with VISMED® in the change of ocular surface staining (OSS) score between baseline and D28. An OSS higher than 0 is considered to be abnormal and may be a sign of KCS. But scores of 1 or 2 can also represent a late staining artifact if interpretation of the fluorescein corneal staining pattern is delayed beyond 8 minutes. Because this could lead to a high level of misclassification, an abnormal OSS is defined as being a score of 3 or above.
Time frame: Between Baseline and day 28
Change of ocular surface staining (OSS) score between baseline and Day 84
The difference between patients treated with Cationorm Pro® and patients treated with VISMED® in change of OSS score between baseline and Day 84. An OSS higher than 0 is considered to be abnormal and may be a sign of KCS. But scores of 1 or 2 can also represent a late staining artifact if interpretation of the fluorescein corneal staining pattern is delayed beyond 8 minutes. Because this could lead to a high level of misclassification, an abnormal OSS is defined as being a score of 3 or above.
Time frame: between baseline and Day 14 and between baseline and Day 84
The change of ocular stainings (corneal fluorescein staining (CFS) and conjunctival staining) between baseline and Day 28 and between baseline and Day 84
The difference between patients treated with Cationorm Pro® and patients treated with VISMED® in change of ocular stainings (corneal fluorescein staining (CFS) and conjunctival staining) Staining using fluorescein will be graded using the modified Oxford scale (7-point ordinal scale, score 0, 0.5, and 1 to 5 per area \[cornea + nasal and temporal conjunctiva\]) for cornea and conjunctiva separately, On this modified scale, the score 0 corresponds to no staining dots and the score 0.5 corresponds to one staining dot per area. A CFS grade of 0 represents complete corneal clearing.
Time frame: between baseline and Day 28 and between baseline and Day 84
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Centro de Oftalmologia Barraquer
Barcelona, Spain
Hospital Clinic of Barcelona
Barcelona, Spain
Hospital Unniversitario Donostia
Donostia / San Sebastian, Spain
El Instituto Ofalmológico Quirónsalud Zaragoza
Zaragoza, Spain
The change of ocular discomfort symptoms on Visual Analogue Scale
The difference between patients treated with Cationorm Pro® and patients treated with VISMED® in the change of ocular discomfort symptoms according to the Visual Analogue Scale (VAS) Patient experiencing at least 2 symptoms of ocular discomfort rated ≥23 mm on the 0 to 100 mm visual analogue scale (VAS) (among itching, eye dryness, sticky feeling, photophobia, pain, burning or stinging, sandy feeling or grittiness, or foreign body sensation) at Screening and Baseline visits.
Time frame: between baseline and Day 28 and between baseline and Day 84
The change tear breakup time (TBUT)
The difference between patients treated with Cationorm Pro® and patients treated with VISMED® in the change of tear breakup time (TBUT) Generally, \>10 seconds is thought to be normal,(10, 11, 12) 5 to 10 seconds, marginal, and \< 5 seconds is considered low. A short tear break-up time is a sign of a poor tear film and the longer it takes the more stable the tear film.
Time frame: between baseline and Day 28 and between baseline and Day 84
The change in Schirmer's tear test
The difference between patients treated with Cationorm Pro® and patients treated with VISMED® in the change of Schirmer's tear test Healthy eyes are considered to leave each strip of paper containing more than 10 millimeters of moisture. Less than 10 millimeters of moisture indicates probable dry eye syndrome
Time frame: between baseline and Day 28 and between baseline and Day 84
The secondary endpoints are the difference between patients treated with Cationorm Pro® and patients treated with VISMED® in the change of overall efficacy evaluation of the investigator
The study investigator at each centre will conduct an overall assessment of the effect of the study device on improvement in the patients DED using the following rating scale: 0 = Unsatisfactory 1. = Not very satisfactory 2. = Satisfactory 3. = Very satisfactory
Time frame: after 12 weeks of treatment (84 days)
The difference between patients treated with Cationorm Pro® and patients treated with VISMED® in the change of subjective assessments evaluation by the patient.
The patient will rate his global evaluation of efficacy using the same rating scale as the Investigator. A subjective assessment is completed of the effect of the study device on improvement in their DED using the following rating scale: 0 = Unsatisfactory 1. = Not very satisfactory 2. = Satisfactory 3. = Very satisfactory
Time frame: between baseline and Day 84