A Phase 3 interventional study of PHMB 0.08% and Propamidine 0.1% in Acanthamoeba Keratitis, sponsored by SIFI SpA. Completed at 6 sites in 3 countries. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2023-08-22.
Sponsored by SIFI SpA · Phase 3, Interventional, and Treatment
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Prospective randomized study to evaluate the efficacy, safety and tolerability of 0.08% polihexanide (PHMB) eye drops in patients affected by acanthamoeba keratitis.
130 subjects were assigned to one of the following 2 treatment groups: Group 1: 0.08% polihexanide (PHMB) + placebo Group 2: 0.02% polihexanide (PHMB) + 0.1% propamidine
This was a randomized, assessor-masked, active-controlled, multiple center, parallel-group phase 3 study to evaluate the efficacy, safety and tolerability of 0.08% polihexanide (PHMB) ophthalmic solution compared to the conventional 0.02% polihexanide (PHMB) + 0.1% propamidine in patients affected by acanthamoeba keratitis.
The study was designed as a superiority study with the possibility to test for non-inferiority if the superiority hypothesis was not met (CPMP/EWP/482/99).The study consisted of an eligibility screening visit, a treatment period including monthly follow-up visits until a clinical resolution was obtained (within a maximum of 1 year), followed by 2 post-treatment off-therapy visits (30 and 90 days after treatment discontinuation). 130 subjects with confirmed diagnosis of acanthamoeba keratitis (clinical signs plus positive confocal microscopy findings) were assigned to one of the following treatment groups in a ratio of 1:1.
Group 1: 0.08% PHMB + placebo Group 2: 0.02% PHMB + 0.1% propamidine
SIFI SpA is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
polihexanide (PHMB) 0.08% and placebo were administered in the affected eye until clinical resolution for a maximum of 12 months
Drug: PHMB 0.08% · Drug: placebo
polihexanide (PHMB) 0.02% and propamidine 0.1% were administered in the affected eye until clinical resolution for a maximum of 12 months
Drug: Propamidine 0.1% · Drug: PHMB 0.02%
16 drops in a day in the affected eye for 5 days followed by 8 drops in a day for 7 days,6 drops in a day for 7 days and 4 drops in a day up to clinical resolution
Also known as: Polihexanide 0.8 mg/ml
16 drops in a day in the affected eye for 5 days followed by 8 drops in a day for 7 days,6 drops in a day for 7 days and 4 drops in a day up to clinical resolution
Also known as: Brolene eye drops
16 drops in a day in the affected eye for 5 days followed by 8 drops in a day for 7 days,6 drops in a day for 7 days and 4 drops in a day up to clinical resolution
Also known as: Brolene vehicle
16 drops in a day in the affected eye for 5 days followed by 8 drops in a day for 7 days,6 drops in a day for 7 days and 4 drops in a day up to clinical resolution
Also known as: Polihexanide 0.2 mg/ml
Clinical Resolution Rate
Percentage of patients cured 30 days after discontinuing all study therapies, within 12 months of randomization
Time frame: 12 months
Time to Cure
Time needed to reach a clinical resolution
Time frame: maximum 12 months
Visual Acuity
Final visual acuity (best corrected)
Time frame: maximum 12 months
Participants were recruited from August 2017 and March 2021. Of the 135 enrolled participants 134 were randomized to treatment
| Milestone | PHMB 0.08% Plus Placebo | PHMB 0.02% Plus Propamidine 0.1% |
|---|---|---|
| Started | 69 | 65 |
| Completed | 56 | 54 |
| Not completed | 13 | 11 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Adverse event | 8 | 7 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Diagnosis not confirmed | 3 | 4 |
Percentage of patients cured 30 days after discontinuing all study therapies, within 12 months of randomization
| percentage of participants | PHMB 0.08% Plus Placebo | PHMB 0.02% Plus Propamidine 0.1% |
|---|---|---|
| Clinical Resolution Rate | 84.8 (73.9 to 92.5) | 88.5 (77.8 to 95.3) |
Time needed to reach a clinical resolution
| days | PHMB 0.08% Plus Placebo | PHMB 0.02% Plus Propamidine 0.1% |
|---|---|---|
| Time to Cure | 140 (117 to 150) | 114 (91 to 127) |
Final visual acuity (best corrected)
| LogMAR | PHMB 0.08% Plus Placebo | PHMB 0.02% Plus Propamidine 0.1% |
|---|---|---|
| Visual Acuity | 0.000 (0.000 to 0.250) | 0.000 (-0.080 to 0.150) |
Collected over 1 year. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PHMB 0.08% Plus Placebo | 0/69 (0%) | 0/69 (0%) | 31/69 (44.9%) |
| PHMB 0.02% Plus Propamidine 0.1% | 0/65 (0%) | 0/65 (0%) | 29/65 (44.6%) |
| Event | PHMB 0.08% Plus Placebo | PHMB 0.02% Plus Propamidine 0.1% |
|---|---|---|
| eye painEye disorders | 9/69 | 7/65 |
| ocular hyperemiaEye disorders | 8/69 | 7/65 |
| lacrimation increasedEye disorders | 6/69 | 2/65 |
| eye irritationEye disorders | 1/69 | 4/65 |
| conjunctival hyperemiaEye disorders | 2/69 | 3/65 |
| photophobiaEye disorders | 2/69 | 3/65 |
| eye inflammationEye disorders | 3/69 | 1/65 |
| corneal epithelium defectEye disorders | 3/69 | 0/65 |
| corneal infiltratesEye disorders | 3/69 | 0/65 |
| eye pruritusEye disorders | 1/69 | 2/65 |
| Age, Continuous(years) | PHMB 0.08% Plus Placebo | PHMB 0.02% Plus Propamidine 0.1% | Total |
|---|---|---|---|
| Median | 33 (25 to 43) | 36 (26 to 49) | 35 (25 to 46) |
| Sex: Female, Male(Participants) | PHMB 0.08% Plus Placebo | PHMB 0.02% Plus Propamidine 0.1% | Total |
|---|---|---|---|
| Female | 41 | 37 | 78 |
| Male | 28 | 28 | 56 |
| Race and Ethnicity Not Collected(Participants) | PHMB 0.08% Plus Placebo | PHMB 0.02% Plus Propamidine 0.1% | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Visual acuity (best corrected)(LogMAR) | PHMB 0.08% Plus Placebo | PHMB 0.02% Plus Propamidine 0.1% | Total |
|---|---|---|---|
| Median | 0.350 (0.150 to 0.70) | 0.260 (0.100 to 0.480) | 0.300 (0.150 to 0.700) |
| Culture positivity for Acanthamoeba(Participants) | PHMB 0.08% Plus Placebo | PHMB 0.02% Plus Propamidine 0.1% | Total |
|---|---|---|---|
| Count of participants | 19 | 17 | 36 |
| PCR positivity for Acanthamoeba(Participants) | PHMB 0.08% Plus Placebo | PHMB 0.02% Plus Propamidine 0.1% | Total |
|---|---|---|---|
| Count of participants | 33 | 25 | 58 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2017 to primary completion in Jun 2021, 46 months.
Results were first posted in Aug 2023, 2 years 1 month after primary completion.
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Acanthamoeba Keratitis
SIFI SpA