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 ]

Local tolerance and ocular surface (cornea and conjunctival) on the area of administration 24 hours after last administration. It will be performed using a slit lamp which will be performed before, during and after the administration at established times. Adverse events will be registered and the determination of subjective tolerance will use the visual analogical scale in cases where asubjects refers them


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 ]

Corneal pachymetry eye exploration BCVA (best corrected visual acuity) eye fundus evaluation Clinical exploration Side effects


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