Antimicrobial Efficacy of ALT005 Ophthalmic Prep Solution in Healthy Volunteers

NCT01531699 | Completed Phase 3

• 1 other identifier: ALT005/09CL/11/06
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection Secondary to Surgical Procedure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 3 log10 reduction in microbial load

  45 minutes post dose

• 3 log10 reduction in microbial load

  6 hours post dose

Study Arms (3)

ALT005 Ophthalmic Prep Solution

EXPERIMENTAL

Drug: ALT005 Ophthalmic Prep Solution

saline control

PLACEBO COMPARATOR

Other: saline control

Comparator Product

EXPERIMENTAL

Betadine ophthalmic prep solution

Drug: Betadine ophthalmic prep solution

Interventions

ALT005 Ophthalmic Prep Solution DRUG

single application for up to 6 hours

ALT005 Ophthalmic Prep Solution

saline control OTHER

single application for up to 6 hours

saline control

Betadine ophthalmic prep solution DRUG

single application for up to 6 hours

Comparator Product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Altacor Ltd.: lead

Study Sites (1)

Celerion Inc

Neptune City, New Jersey, 07753, United States

Location

Study Officials

• Sandra Connolly, MD

  Celerion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: February 13, 2012
• Study Start: February 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 6, 2020

Record last verified: 2020-11

Locations

US (1)