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Clinical Trials in France / NCT04685109
Active, not recruiting Not applicable

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

NCT04685109 · tracked via the Priya Life Science France tracker
Sponsor
Phase
Not applicable
Started
2021-05-11
Last updated
2025-05-21

Condition(s) studied

Dry Eye Syndromes

Investigational drug(s) / intervention(s)

Alocross 0.2% Unit DoseVismed

Alocross 0.2% Unit Dose: Eye Drops

Vismed: Eye drops

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 conducted at a national level, in France.

The patients will be randomised to receive ALOCROSS® or the reference treatment, VISMED® (ratio 1:1) in an investigator-masked fashion

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Chru Brest Hopital Morvan Brest France
Cabinet Liberal La Rochefoucauld France
Hopital Edouard Herriot - Pavillon C Lyon France
Institut Ophtalmologique Ouest Jules Verne Nantes France
Hopital Necker - Ophtalmologie Paris France
Hopitaux Universitaires Paris-Sud - Hopital Bicetre Le Kremlin-Bicêtre Île-de-France Region

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04685109 on ClinicalTrials.gov ↗ ← All trials in France