Antimicrobial Efficacy of ALT005 Ophthalmic Prep Solution in Healthy Volunteers

Phase 3

Completed

Conditions: Infection Secondary to Surgical Procedure

Interventions: Drug: ALT005 Ophthalmic Prep Solution
Other: saline control
Drug: Betadine ophthalmic prep solution

Registration Number: NCT01531699

Lead Sponsor: Altacor Ltd.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 54

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALT005 Ophthalmic Prep Solution	ALT005 Ophthalmic Prep Solution	-
saline control	saline control	-
Comparator Product	Betadine ophthalmic prep solution	Betadine ophthalmic prep solution

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
3 log10 reduction in microbial load	6 hours post dose	3 log10 reduction in microbial load at 6 hours following application to the forehead compared to Day 1 baseline.