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

Primary Purpose

Acanthamoeba Keratitis

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

0.04% PHMB

0.06% PHMB

0.08% PHMB

PHMB Vehicle

About this trial

This is an interventional treatment trial for Acanthamoeba Keratitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

0.04% PHMB

0.06% PHMB

0.08% PHMB

PHMB Vehicle

Arm 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

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

Outcomes

Primary Outcome Measures

Number of Subjects With Dose-limiting Adverse Events

Secondary Outcome Measures

Plasma Concentration of PHMB

Full Information

NCT ID

NCT02506257

First Posted

July 20, 2015

Last Updated

December 15, 2016

Sponsor

SIFI SpA

1. Study Identification

Unique Protocol Identification Number

NCT02506257

Brief Title

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

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SIFI SpA

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acanthamoeba Keratitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.04% PHMB

Arm Type

Experimental

Arm 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

Arm Title

0.06% PHMB

Arm Type

Experimental

Arm 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

Arm Title

0.08% PHMB

Arm Type

Experimental

Arm 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

Arm Title

PHMB Vehicle

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

0.04% PHMB

Other Intervention Name(s)

Polyhexamethylene Biguanide

Intervention 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

Intervention Type

Drug

Intervention Name(s)

0.06% PHMB

Other Intervention Name(s)

Polyhexamethylene Biguanide

Intervention 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

Intervention Type

Drug

Intervention Name(s)

0.08% PHMB

Other Intervention Name(s)

Polyhexamethylene Biguanide

Intervention 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

Intervention Type

Drug

Intervention Name(s)

PHMB Vehicle

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Subjects With Dose-limiting Adverse Events

Time Frame

up to 21 days from date of randomization

Secondary Outcome Measure Information:

Title

Plasma Concentration of PHMB

Time Frame

Day14

Other Pre-specified Outcome Measures:

Title

Systolic Blood Pressure

Description

Change from baseline systolic blood pressure

Time Frame

Baseline and Day 14

Title

Visual Acuity

Description

Change from baseline Visual acuity. Best corrected visual acuity was reported in decimal fraction. A decrease of visual acuity during treatment was considered a negative safety outcome.

Time Frame

Baseline and Day 14

Title

Ocular Surface Disease Index-OSDI

Description

Change from baseline OSDI at D 14. Score range was betwwen 0-100. An increase of OSDI values with treatment represent a negative outcome.

Time Frame

Baseline and Day 14

Title

Conjunctival Examination

Description

Change from baseline conjunctival staining at Day 14. Staining with lissamine green was used. The density of staining was graded with the Oxford Score. Score range was between 0-15. An increase in the score after treatment represent a negative outcome

Time Frame

Baseline and Day 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

I JE van der meulen, MD

Organizational Affiliation

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

33239413

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.

Results Reference

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

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