Antimicrobial Efficacy of ALT005 Ophthalmic Prep Solution in Healthy Volunteers (NCT01531699) | Clinical Trial Compass
CompletedPhase 3
Antimicrobial Efficacy of ALT005 Ophthalmic Prep Solution in Healthy Volunteers
United States54 participantsStarted 2012-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 surf…