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

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.

Study Overview

• Status: Completed
• Conditions: Infection Secondary to Surgical Procedure
• Intervention / Treatment: Drug: ALT005 Ophthalmic Prep Solution; Other: saline control; Drug: Betadine ophthalmic prep solution

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Neptune, New Jersey, United States, 07753
      • Celerion Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Medically healthy with no clinically significant findings in the screening results
• Non-tobacco/nicotine-containing product users
• Acceptably high normal (>3 log10) flora counts from the designated skin sites on Day -4.
• Voluntarily consent to participate in the study.
• Females reporting spontaneous postmenopausal status
• WOCBP must either be sexually inactive (abstinent) for 14 days prior to screening and remain so through 30 days following administration (topical dosing) of the study drug or have been using acceptable methods of birth control for the times specified
• WOCBP who have undergone sterilization procedures 6 months prior to Day 1

Exclusion Criteria:

• History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic (including sensitive skin on the face), neurological, or psychiatric disease, or any other clinically significant disease not deemed acceptable by the PI.
• Evidence of compromise to skin integrity of forehead or cheek caused by acute rash, exacerbation of dermatitis, exacerbation of acne, or any other acute condition deemed clinically significant by the PI.
• Tattoo, scar, keloid, or other chronic skin condition located on forehead or cheek
• Facial hair growth that would interfere with sample collection procedures.
• Positive urine drug/alcohol or cotinine testing
• Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV).
• History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
• Hypersensitivity or idiosyncratic reaction to any ingredients in ALT005.
• Use of any prescription medication started within 90 days prior to Day 1
• Use of any over-the-counter (OTC) medication, including herbal products, within the 14 days prior to the Day 1
• Blood donation or significant blood loss within 56 days prior to Day 1
• Plasma donation within 7 days prior to Day 1
• Participation in another clinical trial within 30 days prior to Day 1
• Females who are pregnant or lactating, or have a positive pregnancy test at screening or check-in
• Failure to comply with the pre-treatment restrictions related to showering/washing and contact with antimicrobial substances.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ALT005 Ophthalmic Prep Solution	Drug: ALT005 Ophthalmic Prep Solution; single application for up to 6 hours
PLACEBO_COMPARATOR: saline control	Other: saline control; single application for up to 6 hours
EXPERIMENTAL: Comparator Product; Betadine ophthalmic prep solution	Drug: Betadine ophthalmic prep solution; single application for up to 6 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 log10 reduction in microbial load	3 log10 reduction in microbial load at 10 minutes following application to the forehead or cheek compared to Day 1 baseline.	10 minutes post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 log10 reduction in microbial load	3 log10 reduction in microbial load at 45 minutes following application to the forehead or cheek compared to Day 1 baseline.	45 minutes post dose
3 log10 reduction in microbial load	3 log10 reduction in microbial load at 6 hours following application to the forehead compared to Day 1 baseline.	6 hours post dose

Collaborators and Investigators

• Sponsor: Altacor Ltd.
• Investigators: Principal Investigator: Sandra Connolly, MD, Celerion

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: February 9, 2012
• First Submitted That Met QC Criteria: February 10, 2012
• First Posted (ESTIMATE): February 13, 2012

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Pharmaceutical Solutions; Povidone-Iodine
• Other Study ID Numbers: ALT005/09CL/11/06