Trial · NCT03274895
Polihexanide (PHMB) Eye Drops in Patients Affected by Acanthamoeba Keratitis
NCT03274895, Phase 3, Completed, SIFI SpA; results first posted 2023-08-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Polihexanide (PHMB) Eye Drops in Patients Affected by Acanthamoeba Keratitis. Trials, record NCT03274895. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03274895
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Polihexanide (PHMB) Eye Drops in Patients Affected by Acanthamoeba Keratitis
- NCT number
- NCT03274895
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 135 participants, actual
- Lead sponsor
- SIFI SpA
- Conditions
- Acanthamoeba Keratitis
- Interventions
- PHMB 0.08%, Propamidine 0.1%, placebo, PHMB 0.02%
- First posted
- 2017-09-07
- Last updated
- 2023-08-22
- Results first posted
- 2023-08-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Resolution Rate | 12 months | Percentage of patients cured 30 days after discontinuing all study therapies, within 12 months of randomization |
| Secondary | Time to Cure | maximum 12 months | Time needed to reach a clinical resolution |
| Secondary | Visual Acuity | maximum 12 months | Final visual acuity (best corrected) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Resolution Rate | 12 months | Intent-to-treat | percentage of participants | NUMBER |
| SECONDARY | Time to Cure | maximum 12 months | Intent-to-treat | days | MEDIAN |
| SECONDARY | Visual Acuity | maximum 12 months | Intent-to-treat | LogMAR | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Resolution Rate | PHMB 0.08% Plus Placebo | 84.8 | 95% Confidence Interval 73.9 to 92.5 | percentage of participants | |
| Clinical Resolution Rate | PHMB 0.02% Plus Propamidine 0.1% | 88.5 | 95% Confidence Interval 77.8 to 95.3 | percentage of participants | |
| Time to Cure | PHMB 0.08% Plus Placebo | 140 | 95% Confidence Interval 117 to 150 | days | |
| Time to Cure | PHMB 0.02% Plus Propamidine 0.1% | 114 | 95% Confidence Interval 91 to 127 | days | |
| Visual Acuity | PHMB 0.08% Plus Placebo | 0.000 | Inter-Quartile Range 0.000 to 0.250 | LogMAR | |
| Visual Acuity | PHMB 0.02% Plus Propamidine 0.1% | 0.000 | Inter-Quartile Range -0.080 to 0.150 | LogMAR |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PHMB 0.08% Plus Placebo | 69 | |
| Overall Study | STARTED | PHMB 0.02% Plus Propamidine 0.1% | 65 | |
| Overall Study | COMPLETED | PHMB 0.08% Plus Placebo | 56 | |
| Overall Study | COMPLETED | PHMB 0.02% Plus Propamidine 0.1% | 54 | |
| Overall Study | NOT COMPLETED | PHMB 0.08% Plus Placebo | 13 | |
| Overall Study | NOT COMPLETED | PHMB 0.02% Plus Propamidine 0.1% | 11 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | eye pain | Eye disorders | PHMB 0.08% Plus Placebo | 9 | 69 | 11 |
| other | eye pain | Eye disorders | PHMB 0.02% Plus Propamidine 0.1% | 7 | 65 | 7 |
| other | ocular hyperemia | Eye disorders | PHMB 0.08% Plus Placebo | 8 | 69 | 9 |
| other | ocular hyperemia | Eye disorders | PHMB 0.02% Plus Propamidine 0.1% | 7 | 65 | 9 |
| other | lacrimation increased | Eye disorders | PHMB 0.08% Plus Placebo | 6 | 69 | 6 |
| other | lacrimation increased | Eye disorders | PHMB 0.02% Plus Propamidine 0.1% | 2 | 65 | 2 |
| other | conjunctival hyperemia | Eye disorders | PHMB 0.08% Plus Placebo | 2 | 69 | 2 |
| other | conjunctival hyperemia | Eye disorders | PHMB 0.02% Plus Propamidine 0.1% | 3 | 65 | 4 |
| other | eye irritation | Eye disorders | PHMB 0.08% Plus Placebo | 1 | 69 | 1 |
| other | eye irritation | Eye disorders | PHMB 0.02% Plus Propamidine 0.1% | 4 | 65 | 4 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PHMB 0.08% Plus Placebo | 0 | 69 |
| Total, all-cause mortality | PHMB 0.02% Plus Propamidine 0.1% | 0 | 65 |
| Total, other adverse events | PHMB 0.08% Plus Placebo | 31 | 69 |
| Total, other adverse events | PHMB 0.02% Plus Propamidine 0.1% | 29 | 65 |
| Total, serious adverse events | PHMB 0.08% Plus Placebo | 0 | 69 |
| Total, serious adverse events | PHMB 0.02% Plus Propamidine 0.1% | 0 | 65 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PHMB 0.08% Plus Placebo vs PHMB 0.02% Plus Propamidine 0.1%: deaths from any cause | Trial comparisons |
| PHMB 0.08% Plus Placebo vs PHMB 0.02% Plus Propamidine 0.1%: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03274895
GET https://conductscience.org/api/trials/v1/NCT03274895/events?page=2