Clinical Trial: Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase I Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers
Brief Summary: The purpose of this study is to determine whether SYL1001 is safe for the prevention and treatment of ocular pain and dry eye syndrome.
Detailed Summary:
Sponsor: Sylentis, S.A.
Current Primary Outcome: Local tolerance assessment of cornea and conjunctival sac after administration of one dose of SYL1001 for period 1 and after 7 days of administration of SYL1001 with one dose per day for period 2. [ Time Frame: Period I: 3 days, Period II: 11 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: General tolerance assessment after administration of one dose of SYL1001 (period 1) and after 7 days administration (period 2) [ Time Frame: Period I: 3 days; Period II: 11 days ]
Original Secondary Outcome: Same as current
Information By: Sylentis, S.A.
Dates:
Date Received: September 14, 2011
Date Started: July 2011
Date Completion:
Last Updated: July 16, 2012
Last Verified: July 2012