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

Randomized, 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

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.