Clinical Trial: Safety and Tolerability of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized, Double-Masked, Placebo-Controlled Multiple-Dose Phase 1 Study to Evaluate the Safety and Tolerability of Different Doses of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic

Brief Summary: Randomized, double-masked, placebo-controlled, multiple center, parallel-group Phase 1 study to evaluate the safety and tolerability of 3 doses of preservative-free PHMB ophthalmic solution compared to placebo in healthy subjects

Detailed Summary: The primary objective of the study is to establish the ocular safety and tolerability, and systemic safety of 3 different concentrations of preservative-free PHMB in healthy subjects. Safety and tolerability will be compared to those of a placebo.The PHMB bioavailability in plasma will also be assessed
Sponsor: SIFI SpA

Current Primary Outcome: Number of Subjects With Dose-limiting Adverse Events [ Time Frame: up to 21 days from date of randomization ]

Original Primary Outcome: Number of subjects with adverse events [ Time Frame: up to 21 days from date of randomization ]

Current Secondary Outcome: Plasma Concentration of PHMB [ Time Frame: Day14 ]

Original Secondary Outcome: Plasma Concentration of PHMB [ Time Frame: Day7 and Day14 ]

Information By: SIFI SpA

Dates:
Date Received: July 20, 2015
Date Started: November 2015
Date Completion:
Last Updated: December 15, 2016
Last Verified: December 2016