NCT01531699

Antimicrobial Efficacy of ALT005 Ophthalmic Prep Solution in Healthy Volunteers

An Open-label Study to Assess the Antimicrobial Efficacy of ALT005 Ophthalmic Prep Solution (ALT005) Compared to Control (Sterile Saline) Following Dermal Administration in Healthy Volunteers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Altacor Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, randomized, single-dose, placebo-controlled efficacy study to assess the antimicrobial efficacy of ALT005 ophthalmic prep solution following dermal administration in healthy volunteers. Efficacy will be assessed by comparing the reduction in microbial load for up to 6 hours to that of saline control.

Detailed description

A total of 45 subjects who meet the criteria for inclusion will receive either ALT005 or control solution (sterile 0.9% saline) on one occasion to sites on the forehead and the cheeks. Subjects will be randomized in a ratio of 2:1 active:control. Subjects will be dosed in groups. The study will run at one study center in the US. Subjects will be housed in the clinical research facility from the morning of Day -4 until the evening of Day 1. The total duration of participation for each subject dosed is approximately 21 days (from Day -19 study orientation through the follow-up call on Day 2, excluding the initial screening period). In this study, the efficacy of ALT005 will be assessed in healthy volunteers who, after refraining voluntarily from using topical and oral antimicrobials for at least 2 weeks (14 days), exhibit acceptably high normal flora counts on the designated skin testing sites. An additional cohort was added (3 ALT005, 6 Comparator Product) to make a non-statistical comparison of efficacy.

Conditions

• Infection Secondary to Surgical Procedure

Interventions

Type	Name	Description
DRUG	ALT005 Ophthalmic Prep Solution	single application for up to 6 hours
OTHER	saline control	single application for up to 6 hours
DRUG	Betadine ophthalmic prep solution	single application for up to 6 hours

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2012-02-13
• Last updated: 2020-11-06

Locations

1 site across 1 country: United States