Trial Outcomes & Findings for Safety and Tolerability of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects (NCT NCT02506257)
NCT ID: NCT02506257
Last Updated: 2017-02-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
90 participants
Primary outcome timeframe
up to 21 days from date of randomization
Results posted on
2017-02-09
Participant Flow
Participant milestones
| Measure |
0.04% PHMB
0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% PHMB: 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
0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB: 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
0.08% 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: 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
PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
28
|
27
|
9
|
|
Overall Study
COMPLETED
|
26
|
26
|
23
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
4
|
0
|
Reasons for withdrawal
| Measure |
0.04% PHMB
0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% PHMB: 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
0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB: 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
0.08% 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: 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
PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
3
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Tolerability of Preservative-free Polyhexamethylene Biguanide (PHMB) Ophthalmic Solution in Healthy Subjects
Baseline characteristics by cohort
| Measure |
0.04% PHMB
n=26 Participants
0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% PHMB: 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
n=28 Participants
0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB: 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
n=27 Participants
0.08% 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: 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
n=9 Participants
PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30.5 years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
29.4 years
STANDARD_DEVIATION 8.7 • n=107 Participants
|
30.4 years
STANDARD_DEVIATION 10.3 • n=206 Participants
|
25.7 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
29.6 years
STANDARD_DEVIATION 10.1 • n=31 Participants
|
|
Gender
Female
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
48 Participants
n=31 Participants
|
|
Gender
Male
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
42 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: up to 21 days from date of randomizationOutcome measures
| Measure |
0.04% PHMB
n=26 Participants
0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% PHMB: 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
n=28 Participants
0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB: 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
n=27 Participants
0.08% 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: 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
n=9 Participants
PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
|
|---|---|---|---|---|
|
Number of Subjects With Dose-limiting Adverse Events
|
0 participants
|
2 participants
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day14Outcome measures
| Measure |
0.04% PHMB
n=26 Participants
0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% PHMB: 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
n=28 Participants
0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB: 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
n=27 Participants
0.08% 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: 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
n=9 Participants
PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
|
|---|---|---|---|---|
|
Plasma Concentration of PHMB
|
0 micrograms/ml
Standard Deviation 0
|
0 micrograms/ml
Standard Deviation 0
|
0 micrograms/ml
Standard Deviation 0
|
0 micrograms/ml
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Day 14Change from baseline systolic blood pressure
Outcome measures
| Measure |
0.04% PHMB
n=26 Participants
0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% PHMB: 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
n=28 Participants
0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB: 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
n=27 Participants
0.08% 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: 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
n=9 Participants
PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
|
|---|---|---|---|---|
|
Systolic Blood Pressure
|
-0.7 mmHg
Standard Deviation 9.6
|
0.6 mmHg
Standard Deviation 8.3
|
-0.9 mmHg
Standard Deviation 8.6
|
1.0 mmHg
Standard Deviation 8.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Day 14Change 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.
Outcome measures
| Measure |
0.04% PHMB
n=26 Participants
0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% PHMB: 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
n=28 Participants
0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB: 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
n=27 Participants
0.08% 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: 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
n=9 Participants
PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
|
|---|---|---|---|---|
|
Visual Acuity
|
0.3 decimals
Standard Deviation 1.4
|
0.3 decimals
Standard Deviation 1.3
|
0.3 decimals
Standard Deviation 0.1
|
0.3 decimals
Standard Deviation 0.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Day 14Change from baseline OSDI at D 14. Score range was betwwen 0-100. An increase of OSDI values with treatment represent a negative outcome.
Outcome measures
| Measure |
0.04% PHMB
n=26 Participants
0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% PHMB: 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
n=28 Participants
0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB: 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
n=27 Participants
0.08% 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: 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
n=9 Participants
PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
|
|---|---|---|---|---|
|
Ocular Surface Disease Index-OSDI
|
1.5 scores on a scale
Standard Deviation 3.6
|
1.3 scores on a scale
Standard Deviation 4.1
|
4.2 scores on a scale
Standard Deviation 5.8
|
-2.2 scores on a scale
Standard Deviation 4.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Day 14Change 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
Outcome measures
| Measure |
0.04% PHMB
n=26 Participants
0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% PHMB: 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
n=28 Participants
0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB: 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
n=27 Participants
0.08% 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: 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
n=9 Participants
PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
|
|---|---|---|---|---|
|
Conjunctival Examination
|
0.7 scores on a scale
Standard Deviation 1.3
|
1.2 scores on a scale
Standard Deviation 1.9
|
1.7 scores on a scale
Standard Deviation 1.8
|
1.0 scores on a scale
Standard Deviation 1.7
|
Adverse Events
0.04% PHMB
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
0.06% PHMB
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
0.08% PHMB
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
PHMB Vehicle
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.04% PHMB
n=26 participants at risk
0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.04% PHMB: 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
n=28 participants at risk
0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
0.06% PHMB: 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
n=27 participants at risk
0.08% 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: 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
n=9 participants at risk
PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
|
|---|---|---|---|---|
|
Eye disorders
conjunctival hypermia
|
3.8%
1/26 • Number of events 1 • 1 month
|
14.3%
4/28 • Number of events 4 • 1 month
|
14.8%
4/27 • Number of events 4 • 1 month
|
0.00%
0/9 • 1 month
|
|
General disorders
Instillation site pain
|
7.7%
2/26 • Number of events 2 • 1 month
|
14.3%
4/28 • Number of events 4 • 1 month
|
18.5%
5/27 • Number of events 5 • 1 month
|
11.1%
1/9 • Number of events 1 • 1 month
|
|
Investigations
conjunctival staining
|
7.7%
2/26 • Number of events 3 • 1 month
|
17.9%
5/28 • Number of events 5 • 1 month
|
33.3%
9/27 • Number of events 11 • 1 month
|
0.00%
0/9 • 1 month
|
|
Investigations
corneal staining
|
3.8%
1/26 • Number of events 1 • 1 month
|
17.9%
5/28 • Number of events 5 • 1 month
|
29.6%
8/27 • Number of events 8 • 1 month
|
0.00%
0/9 • 1 month
|
|
Nervous system disorders
headache
|
11.5%
3/26 • Number of events 3 • 1 month
|
14.3%
4/28 • Number of events 5 • 1 month
|
3.7%
1/27 • Number of events 1 • 1 month
|
11.1%
1/9 • Number of events 9 • 1 month
|
|
Eye disorders
eyelid edema
|
0.00%
0/26 • 1 month
|
21.4%
6/28 • Number of events 6 • 1 month
|
0.00%
0/27 • 1 month
|
0.00%
0/9 • 1 month
|
|
General disorders
Instillation site pain erythema
|
7.7%
2/26 • Number of events 2 • 1 month
|
10.7%
3/28 • Number of events 4 • 1 month
|
0.00%
0/27 • 1 month
|
0.00%
0/9 • 1 month
|
|
General disorders
Instillation site pruritus
|
3.8%
1/26 • Number of events 1 • 1 month
|
10.7%
3/28 • Number of events 3 • 1 month
|
3.7%
1/27 • Number of events 1 • 1 month
|
0.00%
0/9 • 1 month
|
|
General disorders
Instillation site foreign body sensation
|
3.8%
1/26 • Number of events 1 • 1 month
|
7.1%
2/28 • Number of events 2 • 1 month
|
3.7%
1/27 • Number of events 1 • 1 month
|
11.1%
1/9 • Number of events 1 • 1 month
|
|
Eye disorders
eye pain
|
0.00%
0/26 • 1 month
|
3.6%
1/28 • Number of events 1 • 1 month
|
0.00%
0/27 • 1 month
|
11.1%
1/9 • Number of events 1 • 1 month
|
|
Infections and infestations
nasopharyngitis
|
0.00%
0/26 • 1 month
|
10.7%
3/28 • Number of events 3 • 1 month
|
0.00%
0/27 • 1 month
|
11.1%
1/9 • Number of events 1 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place