Clinical Trial: Dose-finding Study to Assess the Safety and Effect of SYL1001 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 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 Summary:
Sponsor: Sylentis, S.A.
Current Primary Outcome:
- Change from the baseline scoring of eye pain on the Visual Analogue Scale (VAS) [ Time Frame: 10 consecutive days ]
- Change from the baseline scoring of ocular discomfort in the Ocular Surface Disease Index (OSDI) [ Time Frame: 10 consecutive days ]
- Change from the baseline scoring after fluorescein staining of the cornea [ Time Frame: 10 consecutive days ]
- Frequency of occurrence of conjunctival hyperaemia [ Time Frame: 10 consecutive days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from baseline in vital signs [ Time Frame: 10 consecutive days ]
- Change from baseline in standard laboratory parameters [ Time Frame: 10 consecutive days ]
- Assessment of Adverse Events (AEs) as a measure of SYL1001 safety [ Time Frame: 20 consecutive days ]
- Change from baseline in standard ocular parameters [ Time Frame: 10 consecutive days ]
Original Secondary Outcome: Same as current
Information By: Sylentis, S.A.
Dates:
Date Received: May 20, 2015
Date Started: June 2015
Date Completion:
Last Updated: April 4, 2016
Last Verified: April 2016
