The aim of this pilot study is to compare the analgesic effect of SYL1001 versus placebo in patients with ocular pain associated with Dry Eye Syndrome. General and local tolerability are also evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario Clínico San Carlos
Madrid, Spain
Instituto Oftalmológico Fernández-Vega
Oviedo, Spain
Changes from Baseline in the Ocular Pain Scores on the Visual Analog Scale (VAS) and in the Ocular Discomfort Scores on the Ocular Surface Disease Index (OSDI) as a Measure of SYL1001 Analgesic Effect versus Placebo.
Time frame: 10 days + (4-10 days)
Simple Corneal and Conjunctival Evaluation as a Measure of Safety and Tolerability using Ophthalmic Dyes and a Slit Lamp
Time frame: 10 days + (4-10 days)
Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability
Time frame: 10 days + (96-240 hours)
Evaluation of Vital Signs, Blood, Urine and Ocular Parameters Alterations (IOP, Visual Acuity, Anterior Segment Exploration) Possibly Related to the Investigational Product
Time frame: 10 days + (96-240 hours)
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