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
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
- CFS score ≥4 on a modified Oxford scale
- Ocular hypertension or glaucoma requiring IOP-lowering medication(s)
- History of ocular trauma, infection or ocular inflammatory condition within the last 3months before the screening visit.
- Severe blepharitis and/or severe meibomian gland disease
- Filamentary keratitis
- Any ocular surface anomaly not related to DED
- Active ocular infection or history of ocular allergy or ocular herpes
- Patient with only one sighted eye or with a best corrected distance visual acuity ≤1/10
- 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)
- Onset of lid hygiene (whatever the method) less than 2 months before the Screeningvisit
- Use of topical corticosteroids one month before the Screening Visit
- Use of isotretinoin, ciclosporin, tacrolimus, sirolimus, pimecrolimus or ocularcauterisation procedures 2 months before the screening visit and throughout the study
- Use of VISMED® within 6 weeks prior to the screening visit
- 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
- Insertion of temporary punctal plug(s) within 2 months prior to the Screening visit orpermanent occlusion of lacrimal puncta on one or both sides
- Known hypersensitivity to any of the components of the study device or investigationalproducts Non-ocular
- History of severe systemic allergy
- 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
- Any change of systemic concomitant medication within the month before the screeningvisit or planned change during the study period, except paracetamol
- Pregnancy or lactation at the screening and/or Baseline visit.
- 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.
- Participation in a clinical trial with an investigational substance within the past 30days prior to Baseline visit.
- 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
Connect with a study center
Cabinet Liberal
La Rochefoucauld,
FranceSite Not Available
CHRU Bretonneau
Tours,
FranceSite Not Available
Gabinet Okulistyczny
Bielsko-Biala,
PolandCompleted
Szpital SW. Rozy
Krakow,
PolandCompleted
5th MILITARY CLINICAL HOSPITAL IN KRAKOW
Kraków,
PolandCompleted
Klinika Okulistyki i Onkologii Okulistycznej
Kraków,
PolandSite Not Available
Centro de Oftalmologia Barraquer
Barcelona,
SpainActive - Recruiting
Hospital Clinic of Barcelona
Barcelona,
SpainActive - Recruiting
Hospital Unniversitario Donostia
Donostia,
SpainActive - Recruiting
El Instituto Ofalmológico Quirónsalud Zaragoza
Zaragoza,
SpainActive - Recruiting
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