keratitis,keratoconjunctivitis, dry eyes
Conditions
Interventions
Group 1: treatment with HYLO DUAL INTENSE®, 1 drop 4 times a day for 12 weeks (D84 +/- 8 days)
Group 2: treatment with THEALOSE®, 1 drop 4 times a day for 12 weeks (D84 +/- 8 days)
Sponsors
Laboratoires URSAPHARM SAS
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -Patients who have used artificial tears in the past for few months and, despite this treatment, have symptoms of keratoconjunctivitis and corneal or conjunctival lesions visible through staining. - The following two conditions must be met on the same eye: a) Total ocular surface staining score between = 4 and = 9 on the 15-point Oxford scale (including objective diagnosis of keratoconjunctivitis sicca by staining) b) At least one of the following objective signs: Decreased tear volume: Schirmer test without anesthesia between = 3 mm and = 9 mm / 5 min or: the sum of 3 tear film break-up time (TBUT) measurements = 30 seconds. -The patient agrees not to wear contact lenses during the study - Dry eye symptoms with at least 3 out of 6 symptoms (frequency = 1 and intensity = 2) (ICO index) with symptoms of moderate to severe intensity -The patient is willing and able to comply with study protocol requirements -The patient is affiliated to the social security system - Patient's informed consent form, dated and signed
Exclusion criteria
Exclusion criteria: - Inability to understand the language and/or content of the study for which the informed consent is being obtained - Corneal disease unrelated to dry eyes - Application of artificial tears less than 4 hours before the ophthalmological examinations that will be performed during the admission visit - Prior participation in this study - Concurrent participation in a clinical study, or another clinical study within 4 weeks before and after entering the study - Best corrected visual acuity < 1/10 - Severe blepharitis - Severe dry eye with any of the following a) Anomalies of the eyelids b) Ocular surface metaplasia c) Filamentous keratitis d) Corneal neovascularization - History of eye trauma, eye infection or eye inflammation less than 3 months - History of allergic ocular pathologies or ocular herpes of less than 3 months - Acute infectious or viral eye diseases - History of inflammatory corneal ulcer, recurrent erosion or uveitis - Cataract surgery, laser in situ keratomileusis, photorefractive keratectomy, and other limbal or corneal incision surgeries within the last 12 months - Any ocular surface abnormality not related to dry eye - Intolerance, hypersensitivity, known allergy to one of the components of the two products: HYLO DUAL INTENSE® or THEALOSE® - Patient with hypersensitivity to fluorescein - Women of childbearing potential not using an effective method of contraception (oestrogen-progestin, IUD) must have a pregnancy test and the result must be available prior to the study's fluorescein instillation - Any conditions that may prevent safe participation and interfere with protocol requirements (e.g. alcohol, illegal substances) - Wearing of contact lenses for the duration of the study - All protected persons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the development of the mean values of the total score of the staining of the ocular surface (15-point Oxford scale) from day 35 and day 0 between HYLO DUAL INTENSE® and THEALOSE®. The eye most affected on day 0 is evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Analysis of the mean variations obtained in the total ocular surface staining score on the 15-point Oxford scale at D84 of the most affected eye. - Corneal staining score on the 5-point Oxford scale at D35 and D84 of the most affected eye. - Evaluation of the nasal and temporal conjunctival staining according to the 5-point Oxford scale at D35 and at D84 of the most affected eye. - Frequency and intensity of the following symptoms related to dry eye on D35 and D84 (ICO index): dry eye, foreign body, tingling, fatigue, pain, itching -adverse events | — |
Countries
France
Contacts
Public ContactMarc Childs
LABORATOIRES DELBERT
Outcome results
None listed