Clinical trial NCT02506257: Safety and Tolerability of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acanthamoeba Keratitis
Lead sponsor: SIFI SpA
Sponsor class: INDUSTRY
First posted: 2015-07-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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

Eligibility 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.

Primary outcomes:
measure: Number of Subjects With Dose-limiting Adverse Events
timeFrame: up to 21 days from date of randomization
Secondary outcomes:
measure: Plasma Concentration of PHMB
timeFrame: Day14
Other outcomes:
measure: Systolic Blood Pressure
timeFrame: Baseline and Day 14
measure: Visual Acuity
timeFrame: Baseline and Day 14
measure: Ocular Surface Disease Index-OSDI
timeFrame: Baseline and Day 14
measure: Conjunctival Examination
timeFrame: Baseline and Day 14
Locations:
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: I JE van der meulen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Papa V, van der Meulen I, Rottey S, Sallet G, Overweel J, Asero N, Minassian DC, Dart JKG. Safety and tolerability of topical polyhexamethylene biguanide: a randomised clinical trial in healthy adult volunteers. Br J Ophthalmol. 2022 Feb;106(2):190-196. doi: 10.1136/bjophthalmol-2020-317848. Epub 2020 Nov 25.