Ocular Infection Clinical Trial
Official title:
A Phase 2, Open-Label, Randomized, Parallel Group, Placebo-Controlled, Single-Center Study to Assess Anti-microbial Efficacy and Safety of DCN01 Compared to Unisol® Following Topical Periocular Administration in Healthy Volunteers
| Verified date | January 2016 |
| Source | Deacon Biosciences, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.
| Status | Completed |
| Enrollment | 62 |
| Est. completion date | July 2013 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Have given a written, informed consent - Be willing and able to follow all instructions - A negative urine pregnancy test if female of childbearing potential Exclusion Criteria: - Known sensitivities to study medication or its components - Any signs of an active infection - Use of disallowed products during the period indicated prior to the enrollment or during the study - Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test - Have a condition or a situation which, in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | Andover Eye Associates | Andover | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Deacon Biosciences, Inc. | ORA, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Adverse Events (reported, elicited, observed) | Post dose and up to 2 weeks after (Day 1-14) | Yes | |
| Primary | Change from baseline in periocular region bacterial load | Baseline to 10 min post dose | No | |
| Secondary | Proportion of periocular regions with a reduction from baseline in bacterial load. | Baseline to 10 min post dose | No |