Trial Outcomes & Findings for Polihexanide (PHMB) Eye Drops in Patients Affected by Acanthamoeba Keratitis (NCT NCT03274895)
NCT ID: NCT03274895
Last Updated: 2023-08-22
Results Overview
Percentage of patients cured 30 days after discontinuing all study therapies, within 12 months of randomization
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
135 participants
Primary outcome timeframe
12 months
Results posted on
2023-08-22
Participant Flow
Participants were recruited from August 2017 and March 2021. Of the 135 enrolled participants 134 were randomized to treatment
Participant milestones
| Measure |
PHMB 0.08% Plus Placebo
16 drops of each solution in a day for 5 days,8 drops each in a day for 7 days,6 drops each in a day for 7 days and 4 drops each in a day up to clinical resolution
|
PHMB 0.02% Plus Propamidine 0.1%
16 drops of each solution in a day for 5 days,8 drops each in a day for 7 days,6 drops each in a day for 7 days and 4 drops each in a day up to clinical resolution
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
65
|
|
Overall Study
COMPLETED
|
56
|
54
|
|
Overall Study
NOT COMPLETED
|
13
|
11
|
Reasons for withdrawal
| Measure |
PHMB 0.08% Plus Placebo
16 drops of each solution in a day for 5 days,8 drops each in a day for 7 days,6 drops each in a day for 7 days and 4 drops each in a day up to clinical resolution
|
PHMB 0.02% Plus Propamidine 0.1%
16 drops of each solution in a day for 5 days,8 drops each in a day for 7 days,6 drops each in a day for 7 days and 4 drops each in a day up to clinical resolution
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Adverse Event
|
8
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Diagnosis not confirmed
|
3
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PHMB 0.08% Plus Placebo
n=69 Participants
Polihexanide (PHMB) 0.08% and placebo were administered in the affected eye until clinical resolution for a maximum of 12 months
|
PHMB 0.02% Plus Propamidine 0.1%
n=65 Participants
Polihexanide (PHMB) 0.02% and propamidine 0.1% were administered in the affected eye until clinical resolution for a maximum of 12 months
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33 years
n=69 Participants
|
36 years
n=65 Participants
|
35 years
n=134 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=69 Participants
|
37 Participants
n=65 Participants
|
78 Participants
n=134 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=69 Participants
|
28 Participants
n=65 Participants
|
56 Participants
n=134 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Visual acuity (best corrected)
|
0.350 LogMAR
n=69 Participants
|
0.260 LogMAR
n=65 Participants
|
0.300 LogMAR
n=134 Participants
|
|
Culture positivity for Acanthamoeba
|
19 Participants
n=69 Participants
|
17 Participants
n=65 Participants
|
36 Participants
n=134 Participants
|
|
PCR positivity for Acanthamoeba
|
33 Participants
n=69 Participants
|
25 Participants
n=65 Participants
|
58 Participants
n=134 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Intent-to-treat
Percentage of patients cured 30 days after discontinuing all study therapies, within 12 months of randomization
Outcome measures
| Measure |
PHMB 0.08% Plus Placebo
n=66 Participants
Polihexanide (PHMB) 0.08% and placebo were administered in the affected eye until clinical resolution for a maximum of 12 months
|
PHMB 0.02% Plus Propamidine 0.1%
n=61 Participants
polihexanide (PHMB) 0.02% and propamidine 0.1% were administered in the affected eye until clinical resolution for a maximum of 12 months
|
|---|---|---|
|
Clinical Resolution Rate
|
84.8 percentage of participants
Interval 73.9 to 92.5
|
88.5 percentage of participants
Interval 77.8 to 95.3
|
SECONDARY outcome
Timeframe: maximum 12 monthsPopulation: Intent-to-treat
Time needed to reach a clinical resolution
Outcome measures
| Measure |
PHMB 0.08% Plus Placebo
n=66 Participants
Polihexanide (PHMB) 0.08% and placebo were administered in the affected eye until clinical resolution for a maximum of 12 months
|
PHMB 0.02% Plus Propamidine 0.1%
n=61 Participants
polihexanide (PHMB) 0.02% and propamidine 0.1% were administered in the affected eye until clinical resolution for a maximum of 12 months
|
|---|---|---|
|
Time to Cure
|
140 days
Interval 117.0 to 150.0
|
114 days
Interval 91.0 to 127.0
|
SECONDARY outcome
Timeframe: maximum 12 monthsPopulation: Intent-to-treat
Final visual acuity (best corrected)
Outcome measures
| Measure |
PHMB 0.08% Plus Placebo
n=66 Participants
Polihexanide (PHMB) 0.08% and placebo were administered in the affected eye until clinical resolution for a maximum of 12 months
|
PHMB 0.02% Plus Propamidine 0.1%
n=61 Participants
polihexanide (PHMB) 0.02% and propamidine 0.1% were administered in the affected eye until clinical resolution for a maximum of 12 months
|
|---|---|---|
|
Visual Acuity
|
0.000 LogMAR
Interval 0.0 to 0.25
|
0.000 LogMAR
Interval -0.08 to 0.15
|
Adverse Events
PHMB 0.08% Plus Placebo
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
PHMB 0.02% Plus Propamidine 0.1%
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PHMB 0.08% Plus Placebo
n=69 participants at risk
polihexanide (PHMB) 0.08% and placebo were administered in the affected eye until clinical resolution for a maximum of 12 months
|
PHMB 0.02% Plus Propamidine 0.1%
n=65 participants at risk
polihexanide (PHMB) 0.02% and propamidine 0.1% were administered in the affected eye until clinical resolution for a maximum of 12 months
|
|---|---|---|
|
Eye disorders
eye pain
|
13.0%
9/69 • Number of events 11 • 1 year
|
10.8%
7/65 • Number of events 7 • 1 year
|
|
Eye disorders
ocular hyperemia
|
11.6%
8/69 • Number of events 9 • 1 year
|
10.8%
7/65 • Number of events 9 • 1 year
|
|
Eye disorders
lacrimation increased
|
8.7%
6/69 • Number of events 6 • 1 year
|
3.1%
2/65 • Number of events 2 • 1 year
|
|
Eye disorders
conjunctival hyperemia
|
2.9%
2/69 • Number of events 2 • 1 year
|
4.6%
3/65 • Number of events 4 • 1 year
|
|
Eye disorders
eye irritation
|
1.4%
1/69 • Number of events 1 • 1 year
|
6.2%
4/65 • Number of events 4 • 1 year
|
|
Eye disorders
photophobia
|
2.9%
2/69 • Number of events 2 • 1 year
|
4.6%
3/65 • Number of events 3 • 1 year
|
|
Eye disorders
eye inflammation
|
4.3%
3/69 • Number of events 3 • 1 year
|
1.5%
1/65 • Number of events 3 • 1 year
|
|
Eye disorders
corneal epithelium defect
|
4.3%
3/69 • Number of events 3 • 1 year
|
0.00%
0/65 • 1 year
|
|
Eye disorders
corneal infiltrates
|
4.3%
3/69 • Number of events 3 • 1 year
|
0.00%
0/65 • 1 year
|
|
Eye disorders
eye pruritus
|
1.4%
1/69 • Number of events 1 • 1 year
|
3.1%
2/65 • Number of events 2 • 1 year
|
|
Eye disorders
eye discharge
|
2.9%
2/69 • Number of events 2 • 1 year
|
0.00%
0/65 • 1 year
|
|
Eye disorders
eye swelling
|
2.9%
2/69 • Number of events 2 • 1 year
|
0.00%
0/65 • 1 year
|
|
Eye disorders
keratitis
|
2.9%
2/69 • Number of events 2 • 1 year
|
0.00%
0/65 • 1 year
|
|
Eye disorders
ocular discomfort
|
2.9%
2/69 • Number of events 2 • 1 year
|
0.00%
0/65 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place