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

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 0to 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 inat 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 theinitiation 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 (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 thestudy

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 visitor permanent occlusion of lacrimal puncta on one or both sides

16. Known hypersensitivity to any of the components of the study device orinvestigational 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 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 oralcontraceptives together with condoms, some intrauterine devices, sexual abstinenceor vasectomised partner) from the Baseline visit throughout the conduct of the studytreatment periods and up to 2 weeks after the study end. Post-menopausal women (twoyears 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. -