Infection Secondary to Surgical ProcedurePhase 3NCT01531699
Antimicrobial Efficacy of ALT005 Ophthalmic Prep Solution in Healthy Volunteers
A Phase 3 study testing ALT005 Ophthalmic Prep Solution and Betadine ophthalmic prep solution in people with Infection Secondary to Surgical Procedure, run by Altacor Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection Secondary to Surgical Procedure
- What is being tested?
- ALT005 Ophthalmic Prep Solution and Betadine ophthalmic prep solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- ALT005 Ophthalmic Prep Solution, saline control, Betadine ophthalmic prep solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALT005 Ophthalmic Prep SolutionDrug
single application for up to 6 hours
saline controlOther
single application for up to 6 hours
Betadine ophthalmic prep solutionDrug
single application for up to 6 hours
| Study group | Role | What they receive |
|---|---|---|
| ALT005 Ophthalmic Prep Solution | Experimental | Not described Receives: Drug: ALT005 Ophthalmic Prep Solution |
| saline control | Placebo comparator | Not described Receives: Other: saline control |
| Comparator Product | Experimental | Betadine ophthalmic prep solution Receives: Drug: Betadine ophthalmic prep solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes post dose
Secondary outcomes (2)
3 log10 reduction in microbial load
3 log10 reduction in microbial load at 45 minutes following application to the forehead or cheek compared to Day 1 baseline.
Measured: 45 minutes post dose
3 log10 reduction in microbial load
3 log10 reduction in microbial load at 6 hours following application to the forehead compared to Day 1 baseline.
Measured: 6 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection Secondary to Surgical ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altacor Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandra Connolly, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531699
- Sponsor's protocol ID
- ALT005/09CL/11/06
- Status last verified
- Nov 2020
- First submitted
- 9 Feb 2012
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01531699
- Acronym / sponsor ID
- ALT005/09CL/11/06
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Altacor Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALT005 Ophthalmic Prep Solution | Experimental | Drug: ALT005 Ophthalmic Prep Solution |
| saline control | Placebo comparator | Other: saline control |
| Comparator Product | Experimental | Drug: Betadine ophthalmic prep solutionBetadine ophthalmic prep solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALT005 Ophthalmic Prep Solutionsingle application for up to 6 hours | Drug | ALT005 Ophthalmic Prep Solution |
| saline controlsingle application for up to 6 hours | Other | saline control |
| Betadine ophthalmic prep solutionsingle application for up to 6 hours | Drug | Comparator Product |
Primary outcome
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.
2 secondary outcomes
3 log10 reduction in microbial load
Time frame: 45 minutes post dose
3 log10 reduction in microbial load
Time frame: 6 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Connolly, MD principal investigator
Celerion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ALT005 Ophthalmic Prep Solution and Betadine ophthalmic prep solution in people with Infection Secondary to Surgical Procedure, run by Altacor Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 log10 reduction in microbial load (time frame: 10 minutes post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.