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Antimicrobial Efficacy of ALT005 Ophthalmic Prep Solution in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Altacor Ltd.
ClinicalTrials.gov Identifier:
NCT01531699
First received: February 9, 2012
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Infection Secondary to Surgical Procedure
 Drug: ALT005 Ophthalmic Prep Solution
Other: saline control
Drug: Comparator Product
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Altacor Ltd.:

Primary Outcome Measures:
  • 3 log10 reduction in microbial load [ Time Frame: 10 minutes post dose ] [ Designated as safety issue: No ]
    3 log10 reduction in microbial load at 10 minutes following application to the forehead or cheek compared to Day 1 baseline.


Secondary Outcome Measures:
  • 3 log10 reduction in microbial load [ Time Frame: 45 minutes post dose ] [ Designated as safety issue: No ]
    3 log10 reduction in microbial load at 45 minutes following application to the forehead or cheek compared to Day 1 baseline.

  • 3 log10 reduction in microbial load [ Time Frame: 6 hours post dose ] [ Designated as safety issue: No ]
    3 log10 reduction in microbial load at 6 hours following application to the forehead compared to Day 1 baseline.


Enrollment: 54
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Comparator Product
single application for up to 6 hours
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531699

Locations
United States, New Jersey
Celerion Inc
Neptune, New Jersey, United States, 07753
Sponsors and Collaborators
Altacor Ltd.
Investigators
Principal Investigator: Sandra Connolly, MD Celerion, Inc.
  More Information

No publications provided

Responsible Party: Altacor Ltd.
ClinicalTrials.gov Identifier: NCT01531699     History of Changes
Other Study ID Numbers: ALT005/09CL/11/06
Study First Received: February 9, 2012
Last Updated: December 10, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anti-Infective Agents
Povidone-Iodine
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local

ClinicalTrials.gov processed this record on May 16, 2013