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Antimicrobial Efficacy of ALT005 Ophthalmic Prep Solution in Healthy Volunteers

NCT01531699 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2020-11-06

No results posted yet for this study

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.

Conditions

  • Infection Secondary to Surgical Procedure

Interventions

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

Sponsors & Collaborators

  • Altacor Ltd.

    lead INDUSTRY

Principal Investigators

  • Sandra Connolly, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-10-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01531699 on ClinicalTrials.gov