Antimicrobial Efficacy of ALT005 Ophthalmic Prep Solution in Healthy Volunteers

NCT ID: NCT01531699

Last Updated: 2020-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ALT005 Ophthalmic Prep Solution

Group Type: EXPERIMENTAL

ALT005 Ophthalmic Prep Solution

Intervention Type: DRUG

single application for up to 6 hours

saline control

Group Type: PLACEBO_COMPARATOR

saline control

Intervention Type: OTHER

single application for up to 6 hours

Comparator Product

Betadine ophthalmic prep solution

Group Type: EXPERIMENTAL

Betadine ophthalmic prep solution

Intervention Type: DRUG

single application for up to 6 hours

Interventions

ALT005 Ophthalmic Prep Solution

single application for up to 6 hours

Intervention Type: DRUG

saline control

single application for up to 6 hours

Intervention Type: OTHER

Betadine ophthalmic prep solution

single application for up to 6 hours

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Altacor Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra Connolly, MD

Role: PRINCIPAL_INVESTIGATOR

Celerion

Locations

Celerion Inc

Neptune City, New Jersey, United States

Countries

United States

Other Identifiers

ALT005/09CL/11/06

Identifier Type: -

Identifier Source: org_study_id