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

Launched by SANTEN SAS · Jan 7, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two eye drop treatments, Cationorm Pro® and VISMED®, to see how well they help adults with moderate to severe dry eye disease caused by conditions like keratitis or keratoconjunctivitis. The trial is taking place in France, Poland, and Spain, and aims to determine if Cationorm Pro is as effective as VISMED. Adults aged 18 and older who have been using artificial tears for at least three months and experience specific eye discomfort symptoms may be eligible to participate.

Participants in the study will be randomly assigned to receive either Cationorm Pro or VISMED, and neither the patients nor the investigators will know which treatment they are receiving to ensure fair results. To be eligible, individuals must show signs of dry eye disease on a simple scale and have certain test results related to their eye health. The study is currently recruiting participants, and those interested should be aware that they cannot use other eye treatments during the trial and must meet specific health criteria.

Gender

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Eligibility criteria

• 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.
• • -
• 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. -