3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis … (NCT04701086) | Clinical Trial Compass
CompletedNot Applicable
3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis
France, Poland, Spain83 participantsStarted 2021-09-30
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female patient aged 18 years or above.
✓. Patient using artificial tears for at least 3 months prior to the Screening visit.
✓. 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.
✓. OSS score (sum of nasal and temporal interpalpebral conjunctival and corneal vital staining) ≥4 and ≤9 on a modified Oxford scale at Screening and Baseline visits in at least one eye.
✓. TBUT of ≤10 seconds at Screening and Baseline visits and/or Schirmer's tear test of ≥3 and ≤9 mm/5 min at Screening visit in the same eye that fulfil inclusion criteria #4.
✓. The patient has signed and dated a written informed consent form prior to the initiation of any study procedures.
Exclusion criteria
✕. CFS score ≥4 on a modified Oxford scale
✕. Ocular hypertension or glaucoma requiring IOP-lowering medication(s)
✕. History of ocular trauma, infection or ocular inflammatory condition within the last 3 months before the screening visit.
✕. Severe blepharitis and/or severe meibomian gland disease
✕. Filamentary keratitis
What they're measuring
1
Change of ocular surface staining (OSS) score between baseline and Day 28.