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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: SIFI SpA
• Treatments: Biguanides; Ophthalmic Solutions; Polihexanide; Polyhexamethylene biguanide; Tetrahydrozoline

Criteria

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.