Title
Safety and Tolerability of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects
Randomized, Double-Masked, Placebo-Controlled Multiple-Dose Phase 1 Study to Evaluate the Safety and Tolerability of Different Doses of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects
Phase
Phase 1Lead Sponsor
SIFI SpAStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Acanthamoeba KeratitisIntervention/Treatment
polihexanide ...Study Participants
90Randomized, double-masked, placebo-controlled, multiple center, parallel-group Phase 1 study to evaluate the safety and tolerability of 3 doses of preservative-free PHMB ophthalmic solution compared to placebo in healthy subjects
The primary objective of the study is to establish the ocular safety and tolerability, and systemic safety of 3 different concentrations of preservative-free PHMB in healthy subjects. Safety and tolerability will be compared to those of a placebo.The PHMB bioavailability in plasma will also be assessed
0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
Inclusion Criteria: able and willing to give informed consent. man or woman of any race and 18 to 55 years of age, inclusive. Body Mass Index of 20-30 kg/m2 willing and able to attend required study visits. bilateral visual acuity >6/10. intraocular pressure (IOP) of 14-21 mmHg. ophthalmologic examination without abnormalities. medical history without major pathology. laboratory test results without deviations from the normal range. female subjects of childbearing potential with negative urine pregnancy test and using effective contraception during the study. Exclusion Criteria: presence of bacterial ocular infections. presence of any concomitant ocular pathology. performing activities likely to result in an irritated conjunctiva during the study (including heavy alcohol intake, swimming in chlorinated water and heavy smoking). contact lenses wearing . ocular surface fluorescein staining score >3. use of topical or systemic antibiotics, antihistamines, decongestants and non-steroidal anti-inflammatory agents as well as steroids within 7 days before screening. known or suspected allergy to biguanides or intolerance to any other ingredient of the test treatments. ocular surgery performed within 12 months before screening. participation in another clinical study in the preceding 30 days. one functional eye. pregnancy or breastfeeding. use of recreational drugs.
| Event Type | Organ System | Event Term | 0.04% PHMB | 0.06% PHMB | 0.08% PHMB | PHMB Vehicle |
|---|
Change from baseline systolic blood pressure
Change from baseline Visual acuity. Best corrected visual acuity was reported in decimal fraction. A decrease of visual acuity during treatment was considered a negative safety outcome.
Change from baseline OSDI at D 14. Score range was betwwen 0-100. An increase of OSDI values with treatment represent a negative outcome.
Change from baseline conjunctival staining at Day 14. Staining with lissamine green was used. The density of staining was graded with the Oxford Score. Score range was between 0-15. An increase in the score after treatment represent a negative outcome
