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

Last updated: April 18, 2024
Sponsor: Santen SAS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dry Eyes

Sjogren's Syndrome

Dry Eye Disease

Treatment

Cationorm Pro

Vismed

Clinical Study ID

NCT04701086
RE-010-2020-SA
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 bodysensation) at Screening and Baseline visits. 4. OSS score (sum of nasal and temporal interpalpebral conjunctival and corneal vitalstaining) ≥4 and ≤9 on a modified Oxford scale at Screening and Baseline visits in atleast one eye. 5. TBUT of ≤10 seconds at Screening and Baseline visits and/or Schirmer's tear test of ≥3and ≤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 theinitiation of any study procedures.

Exclusion

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 3months 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 (allnon-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 Screeningvisit
  11. Use of topical corticosteroids one month before the Screening Visit
  12. Use of isotretinoin, ciclosporin, tacrolimus, sirolimus, pimecrolimus or ocularcauterisation 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 ocularlaser/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 orpermanent occlusion of lacrimal puncta on one or both sides
  16. Known hypersensitivity to any of the components of the study device or investigationalproducts 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 theinvestigator to be incompatible with the conduct of the study procedures or theinterpretation of the study results
  19. Any change of systemic concomitant medication within the month before the screeningvisit 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 effectivemethod of birth control (such as hormonal implants, injectable or oral contraceptivestogether with condoms, some intrauterine devices, sexual abstinence or vasectomisedpartner) from the Baseline visit throughout the conduct of the study treatment periodsand up to 2 weeks after the study end. Post-menopausal women (two years withoutmenstruation) do not need to use any method of birth control.
  22. Participation in a clinical trial with an investigational substance within the past 30days prior to Baseline visit.
  23. Participation in another clinical study at the same time as the present study. -

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Cationorm Pro
Phase:
Study Start date:
September 30, 2021
Estimated Completion Date:
December 31, 2024

Study 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

Connect with a study center

  • Cabinet Liberal

    La Rochefoucauld,
    France

    Site Not Available

  • CHRU Bretonneau

    Tours,
    France

    Site Not Available

  • Gabinet Okulistyczny

    Bielsko-Biala,
    Poland

    Completed

  • Szpital SW. Rozy

    Krakow,
    Poland

    Completed

  • 5th MILITARY CLINICAL HOSPITAL IN KRAKOW

    Kraków,
    Poland

    Completed

  • Klinika Okulistyki i Onkologii Okulistycznej

    Kraków,
    Poland

    Site Not Available

  • Centro de Oftalmologia Barraquer

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Clinic of Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Unniversitario Donostia

    Donostia,
    Spain

    Active - Recruiting

  • El Instituto Ofalmológico Quirónsalud Zaragoza

    Zaragoza,
    Spain

    Active - Recruiting

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