Trial Outcomes & Findings for BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study (NCT NCT02537730)
NCT ID: NCT02537730
Last Updated: 2020-08-18
Results Overview
Corneal staining for Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination assessed by slit lamp. Grade 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
1 week
Results posted on
2020-08-18
Participant Flow
Participant milestones
| Measure |
Bioclean MPS VII Combo, Then Aosept Clearcare Combo
Participants were randomized to the Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination for one week, then cross over to the alternative Aosept Clearcare / comfilcon A combination
Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system
comfilcon A: contact lens
|
Aosept Clearcare Combo, Then Bioclean MPS VII Combo
Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week then cross over to the alternative Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination.
Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system
Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
comfilcon A: contact lens
|
|---|---|---|
|
First Intervention (7 Days)
STARTED
|
17
|
16
|
|
First Intervention (7 Days)
COMPLETED
|
17
|
16
|
|
First Intervention (7 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (7 Days)
STARTED
|
17
|
16
|
|
Second Intervention (7 Days)
COMPLETED
|
17
|
16
|
|
Second Intervention (7 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study
Baseline characteristics by cohort
| Measure |
Overall Participants
n=33 Participants
Participants were randomized to the Bioclean MPS VII / comfilcon A combination or Aosept Clearcare / comfilcon A combination for one week, then cross over to the alternative combination.
|
|---|---|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 weekCorneal staining for Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination assessed by slit lamp. Grade 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe.
Outcome measures
| Measure |
Bioclean MPS VII / Comfilcon A Combination
n=66 Eyes
Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.
Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
comfilcon A: contact lens
|
Aosept Clearcare / Comfilcon A Combination
n=66 Eyes
Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.
Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system
comfilcon A: contact lens
|
|---|---|---|
|
Ocular Health - Corneal Staining
Normal
|
45 Eyes
|
53 Eyes
|
|
Ocular Health - Corneal Staining
Trace
|
21 Eyes
|
13 Eyes
|
|
Ocular Health - Corneal Staining
Mild
|
0 Eyes
|
0 Eyes
|
|
Ocular Health - Corneal Staining
Moderate
|
0 Eyes
|
0 Eyes
|
|
Ocular Health - Corneal Staining
Severe
|
0 Eyes
|
0 Eyes
|
SECONDARY outcome
Timeframe: 1 weekSubjective ratings of comfort scores for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent.
Outcome measures
| Measure |
Bioclean MPS VII / Comfilcon A Combination
n=33 Participants
Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.
Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
comfilcon A: contact lens
|
Aosept Clearcare / Comfilcon A Combination
n=33 Participants
Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.
Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system
comfilcon A: contact lens
|
|---|---|---|
|
Comfort
After insertion
|
9.24 units on a scale
Standard Deviation 1.42
|
9.30 units on a scale
Standard Deviation 1.54
|
|
Comfort
After 4 hours of wear
|
9.52 units on a scale
Standard Deviation 0.71
|
9.44 units on a scale
Standard Deviation 1.05
|
|
Comfort
After 8 hours of wear
|
8.99 units on a scale
Standard Deviation 1.03
|
9.10 units on a scale
Standard Deviation 1.16
|
|
Comfort
Before removal
|
8.55 units on a scale
Standard Deviation 1.13
|
8.65 units on a scale
Standard Deviation 1.39
|
|
Comfort
All day comfort
|
9.15 units on a scale
Standard Deviation 0.85
|
8.89 units on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: 1 weekSubjective ratings of dryness for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent.
Outcome measures
| Measure |
Bioclean MPS VII / Comfilcon A Combination
n=33 Participants
Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.
Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
comfilcon A: contact lens
|
Aosept Clearcare / Comfilcon A Combination
n=33 Participants
Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.
Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system
comfilcon A: contact lens
|
|---|---|---|
|
Dryness
After Insertion
|
9.67 units on a scale
Standard Deviation 0.69
|
9.77 units on a scale
Standard Deviation 0.65
|
|
Dryness
After 4 hours of wear
|
9.27 units on a scale
Standard Deviation 0.87
|
9.38 units on a scale
Standard Deviation 0.86
|
|
Dryness
After 8 hours of wear
|
8.65 units on a scale
Standard Deviation 1.22
|
8.91 units on a scale
Standard Deviation 1.03
|
|
Dryness
Before removal
|
8.26 units on a scale
Standard Deviation 1.29
|
8.33 units on a scale
Standard Deviation 1.35
|
|
Dryness
All day dryness
|
8.92 units on a scale
Standard Deviation 1.00
|
8.92 units on a scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: BaselineSubjective ratings of stinging and burning sensation for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination. Scale 0-10, 0=difficult to wear, 10=no sensation at all.
Outcome measures
| Measure |
Bioclean MPS VII / Comfilcon A Combination
n=33 Participants
Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.
Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
comfilcon A: contact lens
|
Aosept Clearcare / Comfilcon A Combination
n=33 Participants
Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.
Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system
comfilcon A: contact lens
|
|---|---|---|
|
Stinging and Burning Sensation
Stinging Sensation
|
9.42 units on a scale
Standard Deviation 0.93
|
9.50 units on a scale
Standard Deviation 0.93
|
|
Stinging and Burning Sensation
Burning Sensation
|
9.97 units on a scale
Standard Deviation 0.17
|
9.91 units on a scale
Standard Deviation 0.38
|
Adverse Events
Bioclean MPS VII / Comfilcon A Combination
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Aosept Clearcare / Comfilcon A Combination
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director Professional Services Organization
Coopervision Japan
Phone: 81-3-5449-6619
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER