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

SIFI

Status and phase: Completed; Phase 1

Conditions: Acanthamoeba Keratitis

Treatments: Drug: PHMB Vehicle; Drug: 0.06% PHMB; Drug: 0.04% PHMB; Drug: 0.08% PHMB

Study type: Interventional

Funder types: Industry

Identifiers

NCT02506257

042SI

Details and patient eligibility

About

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

Full description

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

Enrollment: 90 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 4 patient groups, including a placebo group

0.04% PHMB

Experimental group

Description:

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

Treatment:

Drug: 0.04% PHMB

0.06% PHMB

Experimental group

Description:

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

Treatment:

Drug: 0.06% PHMB

0.08% PHMB

Experimental group

Description:

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

Treatment:

Drug: 0.08% PHMB

PHMB Vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: PHMB Vehicle