Ocular Infection
Conditions
Keywords
DCN01, Ocular Surgical Preparation, Prophylaxis against infection, Pre-operative prep
Brief summary
This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.
Interventions
DRUGDCN01
Three serial applications per periocular region.
DRUGUnisol
Three serial applications per periocular region.
Sponsors
ORA, Inc.
Deacon Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in periocular region bacterial load | Baseline to 10 min post dose |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of periocular regions with a reduction from baseline in bacterial load. | Baseline to 10 min post dose |
Other
| Measure | Time frame |
|---|---|
| Adverse Events (reported, elicited, observed) | Post dose and up to 2 weeks after (Day 1-14) |
Countries
United States
Outcome results
None listed