Safety and Tolerability of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
Acanthamoeba Keratitis
Interventions
DRUG

0.04% PHMB

0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days

DRUG

0.06% PHMB

0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days

DRUG

0.08% PHMB

0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days

DRUG

PHMB Vehicle

PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days

All Listed Sponsors
lead

SIFI SpA

INDUSTRY

NCT02506257 - Safety and Tolerability of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects | Biotech Hunter | Biotech Hunter