Acanthamoeba KeratitisPhase 1NCT02506257
Safety and Tolerability of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects
A Phase 1 study testing 0.04% PHMB, 0.06% PHMB and 0.08% PHMB in people with Acanthamoeba Keratitis, run by SIFI SpA.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acanthamoeba Keratitis
- What is being tested?
- 0.04% PHMB, 0.06% PHMB and 0.08% PHMB
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Apr 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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
Read the 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
- Conditions
- Acanthamoeba Keratitis
- Being tested
- 0.04% PHMB, 0.06% PHMB, 0.08% PHMB, PHMB Vehicle
- Medical subject headings
- Acanthamoeba Keratitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.04% PHMBDrug
Also called Polyhexamethylene Biguanide
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% PHMBDrug
Also called Polyhexamethylene Biguanide
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% PHMBDrug
Also called Polyhexamethylene Biguanide
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 VehicleDrug
PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
| Study group | Role | What they receive |
|---|---|---|
| 0.04% PHMB | Experimental | 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days Receives: Drug: 0.04% PHMB |
| 0.06% PHMB | Experimental | 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days Receives: Drug: 0.06% PHMB |
| 0.08% PHMB | Experimental | 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days Receives: Drug: 0.08% PHMB |
| PHMB Vehicle | Placebo comparator | PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days Receives: Drug: PHMB Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Dose-limiting Adverse Events
Measured: up to 21 days from date of randomization
Secondary outcomes (1)
Plasma Concentration of PHMB
Measured: Day14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startNov 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acanthamoeba KeratitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- SIFI SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- I JE van der meulen, MD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506257
- Sponsor's protocol ID
- 042SI
- Status last verified
- Dec 2016
- First submitted
- 20 Jul 2015
- Last updated
- 9 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 33239413
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02506257
- Acronym / sponsor ID
- 042SI
- Conditions
- Acanthamoeba Keratitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- SIFI SpAIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Posted 23 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.04% PHMB | Experimental | Drug: 0.04% PHMB0.04% 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 | Experimental | Drug: 0.06% PHMB0.06% 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 | Experimental | Drug: 0.08% PHMB0.08% 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 comparator | Drug: PHMB VehiclePHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.04% PHMBAlso: Polyhexamethylene Biguanide0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days | Drug | 0.04% PHMB |
| 0.06% PHMBAlso: Polyhexamethylene Biguanide0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days | Drug | 0.06% PHMB |
| 0.08% PHMBAlso: Polyhexamethylene Biguanide0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days | Drug | 0.08% PHMB |
| PHMB VehiclePHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days | Drug | PHMB Vehicle |
Primary outcome
Number of Subjects With Dose-limiting Adverse Events
Time frame: up to 21 days from date of randomization
1 secondary outcome
Plasma Concentration of PHMB
Time frame: Day14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33239413Papa 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I JE van der meulen, MD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.04% PHMB, 0.06% PHMB and 0.08% PHMB in people with Acanthamoeba Keratitis, run by SIFI SpA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Dose-limiting Adverse Events (time frame: up to 21 days from date of randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02506257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.