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
1 other identifier
interventional
90
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2015
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2015
CompletedFirst Posted
Study publicly available on registry
July 23, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
November 23, 2016
CompletedFebruary 9, 2017
December 1, 2016
5 months
July 20, 2015
August 5, 2016
December 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Dose-limiting Adverse Events
up to 21 days from date of randomization
Secondary Outcomes (1)
Plasma Concentration of PHMB
Day14
Other Outcomes (4)
Systolic Blood Pressure
Baseline and Day 14
Visual Acuity
Baseline and Day 14
Ocular Surface Disease Index-OSDI
Baseline and Day 14
- +1 more other outcomes
Study Arms (4)
0.04% PHMB
EXPERIMENTAL0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB
EXPERIMENTAL0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.08% PHMB
EXPERIMENTAL0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB Vehicle
PLACEBO COMPARATORPHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
Interventions
0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SIFI SpAlead
Related Publications (1)
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.
PMID: 33239413DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. IJE van Der Muelen
- Organization
- AMC Amsterdam
Study Officials
- PRINCIPAL INVESTIGATOR
I JE van der meulen, MD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2015
First Posted
July 23, 2015
Study Start
November 1, 2015
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
February 9, 2017
Results First Posted
November 23, 2016
Record last verified: 2016-12