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

Launched by SANTEN SAS · Dec 22, 2020

Keywords

ClinConnect Summary

This clinical trial is studying two treatments for adults with moderate to severe dry eye disease, specifically related to conditions like keratitis or keratoconjunctivitis. The trial compares a new treatment called ALOCROSS® with an established one called VISMED®. Participants will be randomly assigned to receive either treatment, and the study will take place in various locations across France.

To be eligible for this trial, participants must be at least 18 years old and have been using artificial tears for at least three months. They should also be experiencing significant discomfort in their eyes, such as dryness or burning, and meet certain test scores indicating the severity of their dry eye symptoms. Throughout the study, participants will receive either ALOCROSS® or VISMED® and will be monitored for their eye symptoms and overall comfort. It's important for potential participants to know that they cannot use other eye treatments during the study and must meet specific health criteria to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Patient eligibility is determined according to the following 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:
• * Any patient who meets any of the following criteria (in any eye) will not qualify for entry into 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.