Dose-finding Study to Assess the Safety and Effect of SYL1001 in Patients With Ocular Pain
- Registration Number
- NCT02455999
- Lead Sponsor
- Sylentis, S.A.
- Brief Summary
The aim of this pilot study is to compare the analgesic effect of two strengths of SYL1001 eye drops versus placebo in patients with ocular pain associated with Dry Eye Syndrome. General and local tolerability are also evaluated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
- Give written informed consent to participate in the study, after having received all information relating to the design, aims and possible risks resulting therefrom.
- Common symptoms of persistent, daily, mild to moderate dry eye lasting more than three months: OSDI scale between 13-70 and VAS scale between 2 -7.
- Eye tests in both eyes: Corneal fluorescein staining (Oxford scale > 0), Tear break-up time < 10 seconds and Schirmer's test with anaesthesia < 10 mm/5min.
Exclusion criteria:
- Women who are pregnant or breastfeeding or who have a positive urine pregnancy test. Women who do not commit to use a medically acceptable method of contraception from the time of selection and throughout the study.
- Any current, relevant disease, including respiratory disease, cardiovascular disease, endocrine disease, neurological disease, haematological disease, kidney disease, oncological disease, liver disease, gastrointestinal dysfunction, hypertension or active acute infectious processes.
- Previous chronic or recurrent processes which, according to the investigator, could affect the development of the study.
- Concomitant use of other medications with analgesic activity by any route of administration at the time of entry into the study.
- Change in any concomitant eye and/or systemic medication of the patient one month before the study and during the study.
- Changes in the pre-established administration schedule of artificial tears during the 15 days before the study and during the 10 days of the study.
- Initiation of treatment with cyclosporine or changes in the dosage or administration schedule of cyclosporine within the 6 months before inclusion in the study.
- History of hypersensitivity to drugs.
- Use of contact lenses during the treatment and previous 15 days.
- History of drug abuse or drug or alcohol dependence.
- Laboratory abnormalities which, in the investigator's opinion, are clinically significant.
- Previous refractive surgery.
- Having participated in another clinical trial within the 2 months prior to inclusion.
- Another eye disease that is significant in the investigator's opinion.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SYL1001 eye drops dose D SYL1001 SYL1001 eye drops dose D administration via the ophthalmic route SYL1001 eye drops dose C SYL1001 SYL1001 eye drops dose C administration via the ophthalmic route Placebo Placebo Placebo eye drops administration via the ophthalmic route
- Primary Outcome Measures
Name Time Method Change from the baseline scoring of ocular discomfort in the Ocular Surface Disease Index (OSDI) 10 consecutive days Change from the baseline scoring of eye pain on the Visual Analogue Scale (VAS) 10 consecutive days Change from the baseline scoring after fluorescein staining of the cornea 10 consecutive days Frequency of occurrence of conjunctival hyperaemia 10 consecutive days
- Secondary Outcome Measures
Name Time Method Change from baseline in vital signs 10 consecutive days Change from baseline in standard ocular parameters 10 consecutive days Change from baseline in standard laboratory parameters 10 consecutive days Assessment of Adverse Events (AEs) as a measure of SYL1001 safety 20 consecutive days
Trial Locations
- Locations (6)
Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital U. Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
East Tallinn Central Hospital
🇪🇪Tallinn, Estonia
Eye Clinic Dr. Krista Turman
🇪🇪Tallinn, Estonia
Clínica Universidad de Navarra
🇪🇸Pamplona, Spain