Trial Outcomes & Findings for Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers (NCT NCT01912768)
NCT ID: NCT01912768
Last Updated: 2015-07-09
Results Overview
Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
362 participants
Primary outcome timeframe
Baseline (Day 0), Day 7, Day 30, Day 60, Day 90
Results posted on
2015-07-09
Participant Flow
Subjects were recruited from 17 study centers located in the US.
Of the 362 enrolled, 10 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (352).
Participant milestones
| Measure |
FID 120947A
Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
Renu Fresh
Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Overall Study
STARTED
|
239
|
113
|
|
Overall Study
COMPLETED
|
229
|
109
|
|
Overall Study
NOT COMPLETED
|
10
|
4
|
Reasons for withdrawal
| Measure |
FID 120947A
Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
Renu Fresh
Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
|
Overall Study
Randomized in error
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers
Baseline characteristics by cohort
| Measure |
FID 120947A
n=239 Participants
Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
Renu Fresh
n=113 Participants
Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
Total
n=352 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
35.3 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
34.8 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
174 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
266 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7, Day 30, Day 60, Day 90Population: This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with data in each treatment group, respectively, by visit.
Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
FID 120947A
n=239 Participants
Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
Renu Fresh
n=113 Participants
Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Percentage of Subjects With Visibly Clean Lenses
Day 7, n=236, 113
|
44.5 percentage of subjects
|
39.8 percentage of subjects
|
|
Percentage of Subjects With Visibly Clean Lenses
Day 30, n=234, 112
|
35.0 percentage of subjects
|
31.3 percentage of subjects
|
|
Percentage of Subjects With Visibly Clean Lenses
Day 60, n=232, 110
|
40.5 percentage of subjects
|
32.7 percentage of subjects
|
|
Percentage of Subjects With Visibly Clean Lenses
Day 90, n=229, 109
|
41.9 percentage of subjects
|
33.0 percentage of subjects
|
PRIMARY outcome
Timeframe: Day 7, Day 30, Day 60, Day 90Population: This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit.
Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
FID 120947A
n=239 Participants
Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
Renu Fresh
n=113 Participants
Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 7, Type II, n=55,32
|
63.6 percentage of subjects
|
65.6 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 7, Type III, n=55,32
|
25.5 percentage of subjects
|
25.0 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 7, Type IV, n=55,32
|
10.9 percentage of subjects
|
9.4 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 30, Type II, n=74, 37
|
70.3 percentage of subjects
|
59.5 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 30, Type III, n=74, 37
|
10.8 percentage of subjects
|
16.2 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 30, Type IV, n=74, 37
|
18.9 percentage of subjects
|
24.3 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 60, Type II, n=73, 36
|
63.0 percentage of subjects
|
41.7 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 60, Type III, n=73, 36
|
13.7 percentage of subjects
|
25.0 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 60, Type IV, n=73, 36
|
23.3 percentage of subjects
|
33.3 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 90, Type II, n=69, 42
|
60.9 percentage of subjects
|
59.5 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 90, Type III, n=69, 42
|
18.8 percentage of subjects
|
19.0 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 90, Type IV, n=69, 42
|
20.3 percentage of subjects
|
21.4 percentage of subjects
|
PRIMARY outcome
Timeframe: Day 7, Day 30, Day 60, Day 90Population: This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with film deposits in each treatment group, respectively, by visit.
Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
FID 120947A
n=239 Participants
Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
Renu Fresh
n=113 Participants
Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Percentage of Subjects With Film Deposits by Type
Day 7, Type II, n=114, 56
|
57.0 percentage of subjects
|
58.9 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 7, Type III, n=114, 56
|
16.7 percentage of subjects
|
19.6 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 7, Type IV, n=114, 56
|
26.3 percentage of subjects
|
21.4 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 30, Type II, n=125, 66
|
62.4 percentage of subjects
|
62.1 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 30, Type III, n=125, 66
|
14.4 percentage of subjects
|
13.6 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 30, Type IV, n=125, 66
|
23.2 percentage of subjects
|
24.2 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 60, Type II, n=114, 63
|
63.2 percentage of subjects
|
55.6 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 60, Type III, n=114, 63
|
8.8 percentage of subjects
|
7.9 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 60, Type IV, n=114, 63
|
28.1 percentage of subjects
|
36.5 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 90, Type II, n=114, 59
|
64.9 percentage of subjects
|
50.8 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 90, Type III, n=114, 59
|
10.5 percentage of subjects
|
13.6 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 90, Type IV, n=114, 59
|
24.6 percentage of subjects
|
35.6 percentage of subjects
|
PRIMARY outcome
Timeframe: Day 30/Early ExitPopulation: This analysis population includes all subjects with data at visit.
Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
FID 120947A
n=233 Participants
Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
Renu Fresh
n=112 Participants
Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Average Residual Lens Lysozyme
|
70.2 micrograms per lens
Standard Deviation 192.1
|
114.5 micrograms per lens
Standard Deviation 295.5
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Day 7, Day 30, Day 60, Day 90Population: This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with data in each treatment group, respectively, by visit.
Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
FID 120947A
n=239 Participants
Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
Renu Fresh
n=113 Participants
Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Day 7, 2 Line Increase from Baseline, n=236, 112
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Day 7, 1 Line Increase from Baseline, n=236, 112
|
0.4 percentage of subjects
|
0.9 percentage of subjects
|
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Day 7, No Change from Baseline, n=236, 112
|
97.0 percentage of subjects
|
99.1 percentage of subjects
|
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Day 7, 1 Line Decrease from Baseline, n=236, 112
|
2.5 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Day 7, 2 Line Decrease, n=236, 112
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Day 30, 2 Line Increase from Baseline, n=234, 112
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Day 30, 1 Line Increase from Baseline, n=234, 112
|
2.1 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Day 30, No Change from Baseline, n=234, 112
|
95.7 percentage of subjects
|
99.1 percentage of subjects
|
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Day 30, 1 Line Decrease from Baseline, n=234, 112
|
2.1 percentage of subjects
|
0.9 percentage of subjects
|
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Day 30, 2 Line Decrease from Baseline, n=234, 112
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Day 60, 2 Line Increase from Baseline, n=232, 110
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Day 60, 1 Line Increase from Baseline, n=232, 110
|
1.7 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Day 60, No Change from Baseline, n=232, 110
|
95.7 percentage of subjects
|
98.2 percentage of subjects
|
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Day 60, 1 Line Decrease from Baseline, n=232, 110
|
2.6 percentage of subjects
|
1.8 percentage of subjects
|
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Day 60, 2 Line Decrease from Baseline, n=232, 110
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Day 90, 2 Line Increase from Baseline, n=229, 109
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Day 90, 1 Line Increase from Baseline, n=229, 109
|
2.2 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Day 90, No Change from Baseline, n=229, 109
|
94.3 percentage of subjects
|
98.2 percentage of subjects
|
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Day 90, 1 Line Decrease from Baseline, n=229, 109
|
3.1 percentage of subjects
|
1.8 percentage of subjects
|
|
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
Day 90, 2 Line Decrease from Baseline, n=229, 109
|
0.4 percentage of subjects
|
0.0 percentage of subjects
|
PRIMARY outcome
Timeframe: Day 7, Day 30, Day 60, Day 90Population: This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with data in each treatment group, respectively, by visit.
Subject recorded a response to the question, "Averaging over the last 3 days, how many hours per day did you wear your contact lenses?" Lens wear time was measured in hours.
Outcome measures
| Measure |
FID 120947A
n=239 Participants
Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
Renu Fresh
n=113 Participants
Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Average Lens Wear Time
Day 7, n=236, 113
|
12.9 Hours
Standard Deviation 2.6
|
12.6 Hours
Standard Deviation 2.6
|
|
Average Lens Wear Time
Day 30, n=234, 112
|
12.9 Hours
Standard Deviation 2.7
|
12.6 Hours
Standard Deviation 2.6
|
|
Average Lens Wear Time
Day 60, n=232, 110
|
13.0 Hours
Standard Deviation 2.6
|
12.6 Hours
Standard Deviation 2.6
|
|
Average Lens Wear Time
Day 90, n=229, 109
|
13.1 Hours
Standard Deviation 2.7
|
12.9 Hours
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: Up to Day 90Population: This analysis population includes all randomized subjects.
A fresh pair of lenses was dispensed on Day 0, Day 30, and Day 60. Lenses replaced at other times were considered unscheduled. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.
Outcome measures
| Measure |
FID 120947A
n=239 Participants
Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
Renu Fresh
n=113 Participants
Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Number of Unscheduled Lens Replacements by Reason
Discomfort
|
3 lenses
|
0 lenses
|
|
Number of Unscheduled Lens Replacements by Reason
Lost
|
4 lenses
|
0 lenses
|
|
Number of Unscheduled Lens Replacements by Reason
Lens torn on eye
|
2 lenses
|
0 lenses
|
|
Number of Unscheduled Lens Replacements by Reason
Lens torn while handling
|
5 lenses
|
5 lenses
|
|
Number of Unscheduled Lens Replacements by Reason
Other
|
9 lenses
|
7 lenses
|
PRIMARY outcome
Timeframe: Day 7, Day 30, Day 60, Day 90Population: This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with data in each treatment group, respectively, by visit.
Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
Outcome measures
| Measure |
FID 120947A
n=239 Participants
Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
Renu Fresh
n=113 Participants
Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 7, Strongly Agree, n=236, 113
|
30.1 percentage of subjects
|
36.3 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 7, Agree, n=236, 113
|
55.1 percentage of subjects
|
50.4 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 7, Undecided, n=236, 113
|
5.1 percentage of subjects
|
3.5 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 7, Disagree, n=236, 113
|
8.9 percentage of subjects
|
7.1 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 7, Strongly Disagree, n=236, 113
|
0.8 percentage of subjects
|
2.7 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 30, Strongly Agree, n=234, 112
|
29.9 percentage of subjects
|
24.1 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 30, Agree, n=234, 112
|
50.9 percentage of subjects
|
51.8 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 30, Undecided, n=234, 112
|
5.1 percentage of subjects
|
6.3 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 30, Disagree, n=234, 112
|
12.0 percentage of subjects
|
16.1 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 30, Strongly Disagree, n=234, 112
|
2.1 percentage of subjects
|
1.8 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 60, Strongly Agree, n=232, 110
|
24.6 percentage of subjects
|
21.8 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 60, Agree, n=232, 110
|
54.3 percentage of subjects
|
51.8 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 60, Undecided, n=232, 110
|
6.5 percentage of subjects
|
5.5 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 60, Disagree, n=232, 110
|
13.8 percentage of subjects
|
14.5 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 60, Strongly Disagree, n=232, 110
|
0.9 percentage of subjects
|
6.4 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 90, Strongly Agree, n=229, 109
|
28.8 percentage of subjects
|
23.9 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 90, Agree, n=229, 109
|
54.6 percentage of subjects
|
59.6 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 90, Undecided, n=229, 109
|
4.8 percentage of subjects
|
5.5 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 90, Disagree, n=229, 109
|
10.5 percentage of subjects
|
9.2 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 90, Strongly Disagree, n=229, 109
|
1.3 percentage of subjects
|
1.8 percentage of subjects
|
PRIMARY outcome
Timeframe: Day 7, Day 30, Day 60, Day 90Population: This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with data in each treatment group, respectively, by visit.
Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
Outcome measures
| Measure |
FID 120947A
n=239 Participants
Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
Renu Fresh
n=113 Participants
Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 7, Strongly Agree, n=236, 113
|
30.5 percentage of subjects
|
29.2 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 7, Agree, n=236, 113
|
57.2 percentage of subjects
|
59.3 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 7, Undecided, n=236, 113
|
6.4 percentage of subjects
|
6.2 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 7, Disagree, n=236, 113
|
5.5 percentage of subjects
|
4.4 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 7, Strongly Disagree, n=236, 113
|
0.4 percentage of subjects
|
0.9 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 30, Strongly Agree, n=234, 112
|
27.4 percentage of subjects
|
20.5 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 30, Agree, n=234, 112
|
53.8 percentage of subjects
|
59.8 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 30, Undecided, n=234, 112
|
5.1 percentage of subjects
|
7.1 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 30, Disagree, n=234, 112
|
12.4 percentage of subjects
|
9.8 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 30, Strongly Disagree, n=234, 112
|
1.3 percentage of subjects
|
2.7 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 60, Strongly Agree, n=232, 110
|
20.3 percentage of subjects
|
17.3 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 60, Agree, n=232, 110
|
62.1 percentage of subjects
|
61.8 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 60, Undecided, n=232, 110
|
5.2 percentage of subjects
|
6.4 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 60, Disagree, n=232, 110
|
12.1 percentage of subjects
|
11.8 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 60, Strongly Disagree, n=232, 110
|
0.4 percentage of subjects
|
2.7 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 90, Strongly Agree, n=229, 109
|
24.5 percentage of subjects
|
17.4 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 90, Agree, n=229, 109
|
59.4 percentage of subjects
|
63.3 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 90, Undecided, n=229, 109
|
6.6 percentage of subjects
|
7.3 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 90, Disagree, n=229, 109
|
9.2 percentage of subjects
|
8.3 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 90, Strongly Disagree, n=229, 109
|
0.4 percentage of subjects
|
3.7 percentage of subjects
|
PRIMARY outcome
Timeframe: Day 7, Day 30, Day 60, Day 90Population: This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with data in each treatment group, respectively, by visit.
Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
Outcome measures
| Measure |
FID 120947A
n=239 Participants
Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
Renu Fresh
n=113 Participants
Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 7, Strongly Agree, n=236, 113
|
31.4 percentage of subjects
|
38.1 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 7, Agree, n=236, 113
|
52.1 percentage of subjects
|
47.8 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 7, Undecided, n=236, 113
|
10.2 percentage of subjects
|
6.2 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 7, Disagree, n=236, 113
|
5.9 percentage of subjects
|
4.4 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 7, Strongly Disagree, n=236, 113
|
0.4 percentage of subjects
|
3.5 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 30, Strongly Agree, n=234, 112
|
27.8 percentage of subjects
|
25.0 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 30, Agree, n=234, 112
|
59.0 percentage of subjects
|
59.8 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 30, Undecided, n=234, 112
|
9.0 percentage of subjects
|
6.3 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 30, Disagree, n=234, 112
|
3.0 percentage of subjects
|
8.0 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 30, Strongly Disagree, n=234, 112
|
1.3 percentage of subjects
|
0.9 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 60, Strongly Agree, n=232, 110
|
25.0 percentage of subjects
|
28.2 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 60, Agree, n=232, 110
|
62.5 percentage of subjects
|
51.8 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 60, Undecided, n=232, 110
|
6.5 percentage of subjects
|
10.0 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 60, Disagree, n=232, 110
|
4.7 percentage of subjects
|
8.2 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 60, Strongly Disagree, n=232, 110
|
1.3 percentage of subjects
|
1.8 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 90, Strongly Agree, n=229, 109
|
28.4 percentage of subjects
|
28.4 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 90, Agree, n=229, 109
|
60.7 percentage of subjects
|
56.0 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 90, Undecided, n=229, 109
|
4.8 percentage of subjects
|
7.3 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 90, Disagree, n=229, 109
|
4.8 percentage of subjects
|
6.4 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 90, Strongly Disagree, n=229, 109
|
1.3 percentage of subjects
|
1.8 percentage of subjects
|
PRIMARY outcome
Timeframe: Day 7, Day 30, Day 60, Day 90Population: This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit.
Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
FID 120947A
n=239 Participants
Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
Renu Fresh
n=113 Participants
Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Crystalline Deposit Area Covered
Day 7, n=55, 32
|
12.5 percentage of lens area
Standard Deviation 12.2
|
17.8 percentage of lens area
Standard Deviation 18.5
|
|
Crystalline Deposit Area Covered
Day 30, n=74, 37
|
12.1 percentage of lens area
Standard Deviation 9.8
|
14.0 percentage of lens area
Standard Deviation 16.8
|
|
Crystalline Deposit Area Covered
Day 60, n=73, 36
|
13.0 percentage of lens area
Standard Deviation 10.2
|
13.3 percentage of lens area
Standard Deviation 10.2
|
|
Crystalline Deposit Area Covered
Day 90, n=69, 42
|
12.2 percentage of lens area
Standard Deviation 10.9
|
14.0 percentage of lens area
Standard Deviation 15.1
|
PRIMARY outcome
Timeframe: Day 7, Day 30, Day 60, Day 90Population: This analysis population includes all randomized subjects. Here, "n" is the total number of subjects with film deposits in each treatment group, respectively, by visit.
Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
FID 120947A
n=239 Participants
Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
Renu Fresh
n=113 Participants
Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Film Deposit Area Covered
Day 7, n=114, 56
|
18.7 percentage of lens area
Standard Deviation 12.2
|
16.7 percentage of lens area
Standard Deviation 12.1
|
|
Film Deposit Area Covered
Day 30, n=125, 66
|
18.9 percentage of lens area
Standard Deviation 14.3
|
20.5 percentage of lens area
Standard Deviation 14.4
|
|
Film Deposit Area Covered
Day 60, n=114, 63
|
21.0 percentage of lens area
Standard Deviation 16.1
|
23.4 percentage of lens area
Standard Deviation 15.3
|
|
Film Deposit Area Covered
Day 90, n=114, 59
|
17.3 percentage of lens area
Standard Deviation 12.8
|
20.9 percentage of lens area
Standard Deviation 14.6
|
Adverse Events
Pre-treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FID 120947A
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Renu Fresh
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pre-treatment
n=362 participants at risk
All subjects who consented to participate in the study prior to exposure to investigational product
|
FID 120947A
n=238 participants at risk
All subjects who were exposed to FID 120947A
|
Renu Fresh
n=113 participants at risk
All subjects who were exposed to renu fresh
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
ankle fracture
|
0.00%
0/362 • An Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, whether or not related to the investigational medical device. AEs are reported as pre-treatment and treatment-emergent.
AEs were collected for the duration of the study (Dec 2013-May 2014). AEs were obtained as solicited and volunteered comments from subjects and as observations by the Investigator as outlined in the protocol. One subject was randomized but never received investigational product and was excluded from the safety dataset.
|
0.42%
1/238 • An Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, whether or not related to the investigational medical device. AEs are reported as pre-treatment and treatment-emergent.
AEs were collected for the duration of the study (Dec 2013-May 2014). AEs were obtained as solicited and volunteered comments from subjects and as observations by the Investigator as outlined in the protocol. One subject was randomized but never received investigational product and was excluded from the safety dataset.
|
0.00%
0/113 • An Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, whether or not related to the investigational medical device. AEs are reported as pre-treatment and treatment-emergent.
AEs were collected for the duration of the study (Dec 2013-May 2014). AEs were obtained as solicited and volunteered comments from subjects and as observations by the Investigator as outlined in the protocol. One subject was randomized but never received investigational product and was excluded from the safety dataset.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER