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Antimicrobial Efficacy of ALT005 Ophthalmic Prep Solution in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01531699
Recruitment Status : Completed
First Posted : February 13, 2012
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
Altacor Ltd.

Tracking Information
First Submitted Date  ICMJE February 9, 2012
First Posted Date  ICMJE February 13, 2012
Last Update Posted Date November 6, 2020
Study Start Date  ICMJE February 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
3 log10 reduction in microbial load [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
  • 3 log10 reduction in microbial load [ Time Frame: 45 minutes post dose ]
    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 ]
    3 log10 reduction in microbial load at 6 hours following application to the forehead compared to Day 1 baseline.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antimicrobial Efficacy of ALT005 Ophthalmic Prep Solution in Healthy Volunteers
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Infection Secondary to Surgical Procedure
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: ALT005 Ophthalmic Prep Solution
    Intervention: Drug: ALT005 Ophthalmic Prep Solution
  • Placebo Comparator: saline control
    Intervention: Other: saline control
  • Experimental: Comparator Product
    Betadine ophthalmic prep solution
    Intervention: Drug: Betadine ophthalmic prep solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2012)
54
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2012)
45
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01531699
Other Study ID Numbers  ICMJE ALT005/09CL/11/06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Altacor Ltd.
Study Sponsor  ICMJE Altacor Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sandra Connolly, MD Celerion
PRS Account Altacor Ltd.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP