Phase 1
N=90
Safety and Tolerability of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects
Acanthamoeba Keratitis
Bottom Line
View on ClinicalTrials.gov: NCT02506257 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Number of Subjects With Dose-limiting Adverse Events — 0; 2; 3; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 0.04% PHMB (Drug); 0.06% PHMB (Drug); 0.08% PHMB (Drug); PHMB Vehicle (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- SIFI SpA
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Dose-limiting Adverse Events |
0; 2; 3; 0 | — |
| SECONDARY Plasma Concentration of PHMB |
0; 0; 0; 0 | — |
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
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.
Data sourced from ClinicalTrials.gov (NCT02506257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.