Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail

Inclusion Criteria: * Male and females 18 - 74 years of age inclusive * Fungal toenail infection of one or both of the large (great) toenails * The nail infection must be due to a dermatophyte, (mixed infections \[dermatophyte and non-dermatophyte\] are not allowed) * Willingness not to have professional pedicures or application of any nail polish product or nail cosmetics to the toenails after the screening visit Exclusion Criteria: * History of any significant chronic fungal disease other than onychomycosis or immunocompromised condition * Any abnormalities of the nail or previous surgery of the toenail that could prevent a normal appearing nail if clearing of infection is achieved * Significant confounding conditions as assessed by the study doctor * Participation in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study * No administration of systemic antifungal medications within 6 months prior to screening visit * No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit * Tinea pedis (athlete's foot) that would require systemic treatment Other protocol-defined inclusion/exclusion criteria may apply