3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis

NCT04701086 | Completed

• 1 other identifier: RE-010-2020-SA
• Study Type: interventional
• Target: 83
• Locations: 3 countries
• Sites: 8

Brief 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

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• 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.

  Between Baseline and day 28

Secondary Outcomes (7)

• Change of ocular surface staining (OSS) score between baseline and Day 84

  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

  between baseline and Day 28 and between baseline and Day 84

• The change of ocular discomfort symptoms on Visual Analogue Scale

  between baseline and Day 28 and between baseline and Day 84

• The change tear breakup time (TBUT)

  between baseline and Day 28 and between baseline and Day 84

• The change in Schirmer's tear test

  between baseline and Day 28 and between baseline and Day 84

Study Arms (2)

Cationorm Pro

EXPERIMENTAL

Cationorm Pro is an ophthalmic sterile unpreserved eye drops emulsion (N=40) Posology: One Drop in each eye 4 times daily for 84 days

Device: Cationorm Pro

Vismed

ACTIVE COMPARATOR

HA 0.18% hyaluronic solution (N40) Posology: One Drop in each eye 4 times daily for 84 days

Device: Vismed

Interventions

Cationorm Pro DEVICE

Eye Drops

Also known as: Ocutears Pro+

Cationorm Pro

Vismed DEVICE

Eye Drops

Vismed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The patient has signed and dated a written informed consent form prior to the initiation of any study procedures.

You may not qualify if:

• the study: Ocular
• 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
• Any ocular surface anomaly not related to DED
• Active ocular infection or history of ocular allergy or ocular herpes
• Patient with only one sighted eye or with a best corrected distance visual acuity ≤1/10
• Use of any topical ocular treatment other than study device during the study (all non-study topical ocular treatment(s) must be stopped at the screening visit)
• Onset of lid hygiene (whatever the method) less than 2 months before the Screening visit
• Use of topical corticosteroids one month before the Screening Visit
• Use of isotretinoin, ciclosporin, tacrolimus, sirolimus, pimecrolimus or ocular cauterisation procedures 2 months before the screening visit and throughout the study
• Use of VISMED® within 6 weeks prior to the screening visit
• Refractive surgery (e.g. LASIK, LASEK, PRK) within 6 months and/or any other ocular laser/surgery within 3 months prior to the screening visit and during the study

Sponsors & Collaborators

• Santen SAS: lead

Study Sites (8)

CHRU Bretonneau

Tours, France

Location

Gabinet Okulistyczny

Bielsko-Biala, Poland

Location

5th MILITARY CLINICAL HOSPITAL IN KRAKOW

Krakow, Poland

Location

Szpital SW. Rozy

Krakow, Poland

Location

Centro de Oftalmologia Barraquer

Barcelona, Spain

Location

Hospital Clinic of Barcelona

Barcelona, Spain

Location

Hospital Unniversitario Donostia

Donostia / San Sebastian, Spain

Location

El Instituto Ofalmológico Quirónsalud Zaragoza

Zaragoza, Spain

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator Masked, unmasked Pharmacist
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: PROSPECTIVE, MULTICENTRE, INVESTIGATOR-MASKED, PARALLEL-GROUP, ACTIVE-CONTROLLED, RANDOMISED, NON-INFERIORITY STUDY

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 8, 2021
• Study Start: September 30, 2021
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3); FR (1); ES (4)