Comparative study of HYLO DUAL INTENSE® and THEALOZ® on the signs and symptoms of dry eyes in patients with keratitis or keratoconjunctivitis
- Conditions
- keratitis,keratoconjunctivitis, dry eyes
- Registration Number
- DRKS00030214
- Lead Sponsor
- aboratoires URSAPHARM SAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 80
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
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method - 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.<br>- Corneal staining score on the 5-point Oxford scale at D35 and D84 of the most affected eye.<br>- 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.<br>- 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<br>-adverse events