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

A 3-month, Prospective, Multicentre, Investigator-masked, Parallel-group, Active-controlled, Randomised, Non-inferiority Study to Compare the Efficacy & Tolerability of CATIONORM PRO® & VISMED® in Patients With Mod-to-severe Dry Eye Disease

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Device: Cationorm Pro; Device: Vismed

Detailed Description

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
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Tours, France
    • CHRU Bretonneau
• Poland
  • Bielsko-Biala, Poland
    • Gabinet Okulistyczny
  • Krakow, Poland
    • Szpital Sw. Rozy
  • Kraków, Poland
    • 5th MILITARY CLINICAL HOSPITAL IN KRAKOW
• Spain
  • Barcelona, Spain
    • Centro de Oftalmologia Barraquer
  • Barcelona, Spain
    • Hospital Clinic of Barcelona
  • Donostia, Spain
    • Hospital Unniversitario Donostia
  • Zaragoza, Spain
    • El Instituto Ofalmológico Quirónsalud Zaragoza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female patient aged 18 years or above.
2. Patient using artificial tears for at least 3 months prior to the Screening visit.
3. 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.
4. 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.
5. 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.

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

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Exclusion Criteria:

the study: Ocular

1. CFS score ≥4 on a modified Oxford scale
2. Ocular hypertension or glaucoma requiring IOP-lowering medication(s)
3. History of ocular trauma, infection or ocular inflammatory condition within the last 3 months before the screening visit.
4. Severe blepharitis and/or severe meibomian gland disease
5. Filamentary keratitis
6. Any ocular surface anomaly not related to DED
7. Active ocular infection or history of ocular allergy or ocular herpes
8. Patient with only one sighted eye or with a best corrected distance visual acuity ≤1/10
9. 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)
10. Onset of lid hygiene (whatever the method) less than 2 months before the Screening visit
11. Use of topical corticosteroids one month before the Screening Visit
12. Use of isotretinoin, ciclosporin, tacrolimus, sirolimus, pimecrolimus or ocular cauterisation procedures 2 months before the screening visit and throughout the study
13. Use of VISMED® within 6 weeks prior to the screening visit
14. 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
15. Insertion of temporary punctal plug(s) within 2 months prior to the Screening visit or permanent occlusion of lacrimal puncta on one or both sides
16. Known hypersensitivity to any of the components of the study device or investigational products Non-ocular
17. History of severe systemic allergy
18. Systemic disease not stabilised within 1 month prior to the screening visit (e.g. diabetes with glycaemia out of range, thyroid dysfunction) or judged by the investigator to be incompatible with the conduct of the study procedures or the interpretation of the study results
19. Any change of systemic concomitant medication within the month before the screening visit or planned change during the study period, except paracetamol
20. Pregnancy or lactation at the screening and/or Baseline visit.
21. Women of childbearing potential not using a medically acceptable, highly effective method of birth control (such as hormonal implants, injectable or oral contraceptives together with condoms, some intrauterine devices, sexual abstinence or vasectomised partner) from the Baseline visit throughout the conduct of the study treatment periods and up to 2 weeks after the study end. Post-menopausal women (two years without menstruation) do not need to use any method of birth control.
22. Participation in a clinical trial with an investigational substance within the past 30 days prior to Baseline visit.
23. Participation in another clinical study at the same time as the present study. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vismed; HA 0.18% hyaluronic solution (N40) Posology: One Drop in each eye 4 times daily for 84 days	Device: Vismed; Eye Drops
Experimental: Cationorm Pro; 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; Eye Drops; Other Names: Ocutears Pro+

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	between baseline and Day 28 and between baseline and Day 84
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.	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.	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	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; = Not very satisfactory; = Satisfactory; = Very satisfactory	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; = Not very satisfactory; = Satisfactory; = Very satisfactory	between baseline and Day 84

Collaborators and Investigators

• Sponsor: Santen SAS

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Actual): April 28, 2025
• Study Completion (Actual): April 28, 2025

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: RE-010-2020-SA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No