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

Deacon Biosciences

Status and phase: Completed; Phase 2

Conditions: Ocular Infection

Treatments: Drug: DCN01; Drug: Unisol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01853722

13-150-0002

Details and patient eligibility

About

This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups, including a placebo group

DCN01

Experimental group

Treatment:

Drug: DCN01

Unisol

Placebo Comparator group

Treatment:

Drug: Unisol