Clinical Trial: Pilot Study to Evaluate SYL1001 Safety and Effect in Patients With Ocular Pain
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title:
Brief Summary: 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.
Detailed Summary:
Sponsor: Sylentis, S.A.
Current Primary Outcome:
- 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) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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) ]
Original Secondary Outcome: Same as current
Information By: Sylentis, S.A.
Dates:
Date Received: November 14, 2012
Date Started: November 2012
Date Completion:
Last Updated: May 22, 2015
Last Verified: May 2015
