Trial Outcomes & Findings for Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens (NCT NCT00754338)
NCT ID: NCT00754338
Last Updated: 2023-09-28
Results Overview
Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
76 participants
Primary outcome timeframe
4 weeks
Results posted on
2023-09-28
Participant Flow
Recruitment started January 2008 at CCLR (Study completed July 2008)
Phase 1 - 38 participants enrolled, Phase 2 - 38 participants enrolled. For both Phase 1 and 2 a washout period of at least one day, during which time participants wore spectacles and no contact lenses.
Participant milestones
| Measure |
Ph1: 1st-RepleniSH(No-rub) & Supraclens, 2nd RepleniSH(Rub)
Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) first, and Alcon RepleniSH™ 'with lens rub' second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
|
Ph1: 1st-RepleniSH(Rub), 2nd-RepleniSH(No-rub) & Supraclens
Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' first, and Alcon RepleniSH™ with 'no lens rub' and Supraclens® (Daily protein remover) second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
|
Ph2: 1st-RepleniSH(No-rub)&Supraclens, 2nd ReNUMultiplus(Rub)
Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) first, and B\&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
|
Ph2: 1st-ReNu Multiplus(Rub), 2nd RepleniSH(No-rub)&Supraclens
Phase 2 - B\&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' first, and Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
|
|---|---|---|---|---|
|
First Intervention for Phase1&Phase2
STARTED
|
17
|
21
|
19
|
19
|
|
First Intervention for Phase1&Phase2
COMPLETED
|
17
|
18
|
16
|
19
|
|
First Intervention for Phase1&Phase2
NOT COMPLETED
|
0
|
3
|
3
|
0
|
|
Second Intervention for Phase1&Phase2
STARTED
|
17
|
18
|
16
|
19
|
|
Second Intervention for Phase1&Phase2
COMPLETED
|
17
|
17
|
16
|
18
|
|
Second Intervention for Phase1&Phase2
NOT COMPLETED
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Ph1: 1st-RepleniSH(No-rub) & Supraclens, 2nd RepleniSH(Rub)
Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) first, and Alcon RepleniSH™ 'with lens rub' second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
|
Ph1: 1st-RepleniSH(Rub), 2nd-RepleniSH(No-rub) & Supraclens
Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' first, and Alcon RepleniSH™ with 'no lens rub' and Supraclens® (Daily protein remover) second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
|
Ph2: 1st-RepleniSH(No-rub)&Supraclens, 2nd ReNUMultiplus(Rub)
Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) first, and B\&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
|
Ph2: 1st-ReNu Multiplus(Rub), 2nd RepleniSH(No-rub)&Supraclens
Phase 2 - B\&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' first, and Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study.
|
|---|---|---|---|---|
|
First Intervention for Phase1&Phase2
Withdrawal by Subject
|
0
|
3
|
3
|
0
|
|
Second Intervention for Phase1&Phase2
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens
Baseline characteristics by cohort
| Measure |
Ph1: RepleniSH(No-rub) & Supraclens
n=17 Participants
Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
|
Ph1: RepleniSH(Rub)
n=21 Participants
Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
|
Ph2: RepleniSH(No-rub) & Supraclens
n=19 Participants
Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
|
Ph2: ReNu Multiplus(Rub)
n=19 Participants
Phase 2 - B\&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
76 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
28 years
STANDARD_DEVIATION 11 • n=99 Participants
|
21 years
STANDARD_DEVIATION 3 • n=107 Participants
|
30 years
STANDARD_DEVIATION 9 • n=206 Participants
|
24 years
STANDARD_DEVIATION 7 • n=7 Participants
|
26 years
STANDARD_DEVIATION 9 • n=31 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
61 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
|
Region of Enrollment
Canada
|
17 participants
n=99 Participants
|
21 participants
n=107 Participants
|
19 participants
n=206 Participants
|
19 participants
n=7 Participants
|
76 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: analysis was per protocol
Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'.
Outcome measures
| Measure |
Ph1: RepleniSH(No-rub) & Supraclens
n=34 Participants
Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
|
Ph1: RepleniSH(Rub)
n=34 Participants
Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group
|
Ph2: RepleniSH(No-rub) & Supraclens
n=34 Participants
Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
|
Ph2: ReNu Multiplus(Rub)
n=34 Participants
Phase 2 - B\&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
|
|---|---|---|---|---|
|
Comfort
|
86 Units on a scale
Standard Deviation 13
|
86 Units on a scale
Standard Deviation 15
|
87 Units on a scale
Standard Deviation 14
|
86 Units on a scale
Standard Deviation 14
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: analysis was per protocol
Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced).
Outcome measures
| Measure |
Ph1: RepleniSH(No-rub) & Supraclens
n=34 Participants
Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
|
Ph1: RepleniSH(Rub)
n=34 Participants
Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group
|
Ph2: RepleniSH(No-rub) & Supraclens
n=34 Participants
Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
|
Ph2: ReNu Multiplus(Rub)
n=34 Participants
Phase 2 - B\&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
|
|---|---|---|---|---|
|
Lens Wettability
|
0.71 Units on a scale
Standard Deviation 0.49
|
0.72 Units on a scale
Standard Deviation 0.38
|
0.92 Units on a scale
Standard Deviation 0.68
|
1.21 Units on a scale
Standard Deviation 0.69
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: analysis was per protocol
Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits).
Outcome measures
| Measure |
Ph1: RepleniSH(No-rub) & Supraclens
n=34 Participants
Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
|
Ph1: RepleniSH(Rub)
n=34 Participants
Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group
|
Ph2: RepleniSH(No-rub) & Supraclens
n=34 Participants
Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
|
Ph2: ReNu Multiplus(Rub)
n=34 Participants
Phase 2 - B\&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
|
|---|---|---|---|---|
|
Lens Deposits
|
0.51 Units on a scale
Standard Deviation 0.34
|
0.54 Units on a scale
Standard Deviation 0.47
|
0.62 Units on a scale
Standard Deviation 0.43
|
0.93 Units on a scale
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: analysis was per protocol
Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'.
Outcome measures
| Measure |
Ph1: RepleniSH(No-rub) & Supraclens
n=34 Participants
Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
|
Ph1: RepleniSH(Rub)
n=34 Participants
Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group
|
Ph2: RepleniSH(No-rub) & Supraclens
n=34 Participants
Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
|
Ph2: ReNu Multiplus(Rub)
n=34 Participants
Phase 2 - B\&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
|
|---|---|---|---|---|
|
Dryness
|
85 Units on a Scale
Standard Deviation 14
|
86 Units on a Scale
Standard Deviation 16
|
85 Units on a Scale
Standard Deviation 15
|
85 Units on a Scale
Standard Deviation 15
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: analysis was per protocol
Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'.
Outcome measures
| Measure |
Ph1: RepleniSH(No-rub) & Supraclens
n=34 Participants
Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
|
Ph1: RepleniSH(Rub)
n=34 Participants
Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group
|
Ph2: RepleniSH(No-rub) & Supraclens
n=34 Participants
Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
|
Ph2: ReNu Multiplus(Rub)
n=34 Participants
Phase 2 - B\&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
|
|---|---|---|---|---|
|
Subjective Vision
|
89 Units on a scale
Standard Deviation 12
|
89 Units on a scale
Standard Deviation 13
|
90 Units on a scale
Standard Deviation 11
|
90 Units on a scale
Standard Deviation 11
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: analysis was per protocol
Grading based on Type (0=None; 100=patch)and extent of staining (0=None; 100= Entire corneal region). Final value is Type multiplied by Extent. Corneal staining is a test that uses an orange dye (fluorescein) and a blue light to detect damage to the cornea (front surface of eye) from minor abrasions. A strip of blotting paper containing the dye was touched to the eyelid margin. Upon blinking, the dye spreads and coats the front surface of the eye along with the tear film covering the surface of the cornea. The investigator then rated the size, location and shape of the staining.
Outcome measures
| Measure |
Ph1: RepleniSH(No-rub) & Supraclens
n=34 Participants
Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
|
Ph1: RepleniSH(Rub)
n=34 Participants
Phase 1 - Comfort data for Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group
|
Ph2: RepleniSH(No-rub) & Supraclens
n=34 Participants
Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group.
|
Ph2: ReNu Multiplus(Rub)
n=34 Participants
Phase 2 - B\&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
|
|---|---|---|---|---|
|
Corneal Staining
|
47 Units on a scale
Standard Deviation 111
|
55 Units on a scale
Standard Deviation 113
|
52 Units on a scale
Standard Deviation 108
|
322 Units on a scale
Standard Deviation 479
|
Adverse Events
Ph1: RepleniSH(No-rub) & Supraclens
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ph1: RepleniSH(Rub)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ph2: RepleniSH(No-rub) & Supraclens
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ph2: ReNu Multiplus(Rub)
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
Craig A Woods, Research Manager
Centre for Contact Lens Research
Phone: 1 519 888 4567
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60