Trial Outcomes & Findings for Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Gas Permeable Contact Lens Wearers (NCT NCT01912781)
NCT ID: NCT01912781
Last Updated: 2015-06-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
112 participants
Primary outcome timeframe
Day 7, Day 30, Day 60, Day 90
Results posted on
2015-06-30
Participant Flow
Subjects were recruited from 12 study centers located in the US.
Of the 112 enrolled, 2 subjects were exited as screen failures and 4 were discontinued prior to randomization. This reporting group includes all randomized subjects (106).
Participant milestones
| Measure |
FID 120974A
Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
Boston Simplus
Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
35
|
|
Overall Study
COMPLETED
|
69
|
35
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
FID 120974A
Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
Boston Simplus
Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Gas Permeable Contact Lens Wearers
Baseline characteristics by cohort
| Measure |
FID 120974A
n=71 Participants
Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
Boston Simplus
n=35 Participants
Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
52.1 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7, Day 30, Day 60, Day 90Population: This analysis population includes all subjects with data at 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 120974A
n=69 Participants
Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
Boston Simplus
n=35 Participants
Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Percentage of Subjects With Visibly Clean Lenses
Day 90
|
30.4 percentage of subjects
|
31.4 percentage of subjects
|
|
Percentage of Subjects With Visibly Clean Lenses
Day 7
|
42.0 percentage of subjects
|
57.1 percentage of subjects
|
|
Percentage of Subjects With Visibly Clean Lenses
Day 30
|
29.0 percentage of subjects
|
42.9 percentage of subjects
|
|
Percentage of Subjects With Visibly Clean Lenses
Day 60
|
29.0 percentage of subjects
|
42.9 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 120974A
n=71 Participants
Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
Boston Simplus
n=35 Participants
Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 7, Type II, n=10, 5
|
90.0 percentage of subjects
|
80.0 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 7, Type III, n=10, 5
|
0.0 percentage of subjects
|
20.0 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 7, Type IV, n=10, 5
|
10.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 30, Type II, n=17, 3
|
70.6 percentage of subjects
|
100.0 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 30, Type III, n=17, 3
|
17.6 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 30, Type IV, n=17, 3
|
11.8 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 60, Type II, n=18, 8
|
61.1 percentage of subjects
|
87.5 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 60, Type III, n=18, 8
|
16.7 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 60, Type IV, n=18, 8
|
22.2 percentage of subjects
|
12.5 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 90, Type II, n=21, 10
|
61.9 percentage of subjects
|
60.0 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 90, Type III, n=21, 10
|
23.8 percentage of subjects
|
10.0 percentage of subjects
|
|
Percentage of Subjects With Crystalline Deposits by Type
Day 90, Type IV, n=21, 10
|
14.3 percentage of subjects
|
30.0 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 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 120974A
n=71 Participants
Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
Boston Simplus
n=35 Participants
Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Percentage of Subjects With Film Deposits by Type
Day 30, Type IV, n=47, 20
|
17.0 percentage of subjects
|
10.0 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 7, Type II, n=40, 15
|
80.0 percentage of subjects
|
66.7 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 7, Type III, n=40, 15
|
7.5 percentage of subjects
|
26.7 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 7, Type IV, n=40, 15
|
12.5 percentage of subjects
|
6.7 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 30, Type II, n=47, 20
|
72.3 percentage of subjects
|
80.0 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 30, Type III, n=47, 20
|
10.6 percentage of subjects
|
10.0 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 60, Type II, n=47, 20
|
74.5 percentage of subjects
|
80.0 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 60, Type III, n=47, 20
|
21.3 percentage of subjects
|
5.0 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 60, Type IV, n=47, 20
|
4.3 percentage of subjects
|
15.0 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 90, Type II, n=45, 24
|
73.3 percentage of subjects
|
79.2 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 90, Type III, n=45, 24
|
13.3 percentage of subjects
|
8.3 percentage of subjects
|
|
Percentage of Subjects With Film Deposits by Type
Day 90, Type IV, n=45, 24
|
13.3 percentage of subjects
|
12.5 percentage of subjects
|
PRIMARY outcome
Timeframe: Day 90/Early ExitPopulation: This analysis population includes all randomized subjects.
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 120974A
n=71 Participants
Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
Boston Simplus
n=35 Participants
Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Average Residual Lens Lysozyme
|
0.2 micrograms per lens
Standard Deviation 0.5
|
0.2 micrograms per lens
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: Baseline (Day 0), Day 7, Day 30, Day 60, Day 90Population: This analysis population includes all subjects with data at 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 120974A
n=69 Participants
Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
Boston Simplus
n=35 Participants
Multi-action solution used with gas permeable 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, 1 Line Decrease from Baseline
|
4.3 percentage of subjects
|
5.7 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
|
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
|
1.4 percentage of subjects
|
2.9 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
|
97.1 percentage of subjects
|
94.3 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 Increase from Baseline
|
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
|
2.9 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, No Change from Baseline
|
92.8 percentage of subjects
|
94.3 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 from Baseline
|
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
|
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
|
1.4 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
|
95.7 percentage of subjects
|
97.1 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
|
2.9 percentage of subjects
|
2.9 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
|
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
|
1.4 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 Decrease from Baseline
|
0.0 percentage of subjects
|
2.9 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
|
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
|
0.0 percentage of subjects
|
2.9 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
|
0.0 percentage of subjects
|
2.9 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
|
97.1 percentage of subjects
|
91.4 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
|
2.9 percentage of subjects
|
2.9 percentage of subjects
|
PRIMARY outcome
Timeframe: Day 7, Day 30, Day 60, Day 90Population: This analysis population includes all subjects with data at 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 120974A
n=69 Participants
Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
Boston Simplus
n=35 Participants
Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Average Lens Wear Time
Day 7
|
12.3 Hours
Standard Deviation 2.7
|
13.3 Hours
Standard Deviation 2.4
|
|
Average Lens Wear Time
Day 30
|
12.5 Hours
Standard Deviation 2.7
|
12.7 Hours
Standard Deviation 2.8
|
|
Average Lens Wear Time
Day 60
|
11.8 Hours
Standard Deviation 2.9
|
13.3 Hours
Standard Deviation 2.6
|
|
Average Lens Wear Time
Day 90
|
12.4 Hours
Standard Deviation 2.8
|
13.1 Hours
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: Up to Day 90Population: This analysis population includes all randomized subjects.
No lens replacements were planned during the study. Lenses could be replaced as needed due to loss, damage, or as deemed necessary by the Investigator. If it became necessary to replace a lens, the subject was examined at an unscheduled visit. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.
Outcome measures
| Measure |
FID 120974A
n=71 Participants
Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
Boston Simplus
n=35 Participants
Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Number of Unscheduled Lens Replacements by Reason
Lost
|
3 lenses
|
1 lenses
|
|
Number of Unscheduled Lens Replacements by Reason
Lens torn on eye
|
0 lenses
|
1 lenses
|
|
Number of Unscheduled Lens Replacements by Reason
Lens torn while handling
|
1 lenses
|
0 lenses
|
PRIMARY outcome
Timeframe: Day 7, Day 30, Day 60, Day 90Population: This analysis population includes all subjects with data at 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 120974A
n=69 Participants
Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
Boston Simplus
n=35 Participants
Multi-action solution used with gas permeable 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
|
30.4 percentage of subjects
|
68.6 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 7, Agree
|
52.2 percentage of subjects
|
28.6 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 7, Undecided
|
7.2 percentage of subjects
|
0.0 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 7, Disagree
|
10.1 percentage of subjects
|
2.9 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 7, Strongly Disgree
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 30, Strongly Agree
|
31.9 percentage of subjects
|
68.6 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 30, Agree
|
47.8 percentage of subjects
|
28.6 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 30, Undecided
|
4.3 percentage of subjects
|
2.9 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 30, Disagree
|
13.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 30, Strongly Disagree
|
2.9 percentage of subjects
|
0.0 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 60, Strongly Agree
|
30.4 percentage of subjects
|
62.9 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 60, Agree
|
49.3 percentage of subjects
|
28.6 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 60, Undecided
|
8.7 percentage of subjects
|
0.0 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 60, Disagree
|
10.1 percentage of subjects
|
5.7 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 60, Strongly Disagree
|
1.4 percentage of subjects
|
2.9 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 90, Strongly Agree
|
30.4 percentage of subjects
|
54.3 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 90, Agree
|
50.7 percentage of subjects
|
28.6 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 90, Undecided
|
1.4 percentage of subjects
|
2.9 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 90, Disagree
|
15.9 percentage of subjects
|
11.4 percentage of subjects
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 90, Strongly Disagree
|
1.4 percentage of subjects
|
2.9 percentage of subjects
|
PRIMARY outcome
Timeframe: Day 7, Day 30, Day 60, Day 90Population: This analysis population includes all subjects with data at 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 120974A
n=69 Participants
Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
Boston Simplus
n=35 Participants
Multi-action solution used with gas permeable 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 60, Undecided
|
4.3 percentage of subjects
|
5.7 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 Agree
|
37.7 percentage of subjects
|
48.6 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
|
40.6 percentage of subjects
|
45.7 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
|
2.9 percentage of subjects
|
0.0 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
|
15.9 percentage of subjects
|
5.7 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
|
2.9 percentage of subjects
|
0.0 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
|
29.0 percentage of subjects
|
48.6 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
|
53.6 percentage of subjects
|
45.7 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
|
7.2 percentage of subjects
|
2.9 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 30, Disagree
|
10.1 percentage of subjects
|
2.9 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 Disagree
|
0.0 percentage of subjects
|
0.0 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
|
33.3 percentage of subjects
|
57.1 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
|
49.3 percentage of subjects
|
28.6 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
|
11.6 percentage of subjects
|
8.6 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
|
1.4 percentage of subjects
|
0.0 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
|
29.0 percentage of subjects
|
45.7 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 90, Agree
|
49.3 percentage of subjects
|
34.3 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
|
7.2 percentage of subjects
|
5.7 percentage of subjects
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 90, Disagree
|
13.0 percentage of subjects
|
14.3 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
|
1.4 percentage of subjects
|
0.0 percentage of subjects
|
PRIMARY outcome
Timeframe: Day 7, Day 30, Day 60, Day 90Population: This analysis population includes all subjects with data at 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 120974A
n=69 Participants
Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
Boston Simplus
n=35 Participants
Multi-action solution used with gas permeable 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 60, Disagree
|
2.9 percentage of subjects
|
0.0 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 7, Strongly Agree
|
23.2 percentage of subjects
|
48.6 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 7, Agree
|
50.7 percentage of subjects
|
40.0 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 7, Undecided
|
20.3 percentage of subjects
|
8.6 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 7, Disagree
|
5.8 percentage of subjects
|
2.9 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 7, Strongly Disagree
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 30, Strongly Agree
|
26.1 percentage of subjects
|
57.1 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 30, Agree
|
53.6 percentage of subjects
|
34.3 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 30, Undecided
|
13.0 percentage of subjects
|
8.6 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 30, Disagree
|
5.8 percentage of subjects
|
0.0 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 30, Strongly Disagree
|
1.4 percentage of subjects
|
0.0 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 60, Strongly Agree
|
26.1 percentage of subjects
|
51.4 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 60, Agree
|
56.5 percentage of subjects
|
34.3 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 60, Undecided
|
14.5 percentage of subjects
|
11.4 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 60, Strongly Disagree
|
0.0 percentage of subjects
|
2.9 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 90, Strongly Agree
|
27.5 percentage of subjects
|
48.6 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 90, Agree
|
52.2 percentage of subjects
|
40.0 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 90, Undecided
|
11.6 percentage of subjects
|
5.7 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 90, Disagree
|
7.2 percentage of subjects
|
2.9 percentage of subjects
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 90, Strongly Disagree
|
1.4 percentage of subjects
|
2.9 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 120974A
n=71 Participants
Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
Boston Simplus
n=35 Participants
Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Crystalline Deposit Area Covered
Day 7, n=10, 5
|
18.0 percentage of lens area
Standard Deviation 16.2
|
19.0 percentage of lens area
Standard Deviation 18.2
|
|
Crystalline Deposit Area Covered
Day 30, n=17, 3
|
13.6 percentage of lens area
Standard Deviation 18.1
|
16.7 percentage of lens area
Standard Deviation 20.2
|
|
Crystalline Deposit Area Covered
Day 60, n=18, 8
|
11.9 percentage of lens area
Standard Deviation 14.1
|
7.0 percentage of lens area
Standard Deviation 3.5
|
|
Crystalline Deposit Area Covered
Day 90, n=21, 10
|
18.1 percentage of lens area
Standard Deviation 16.3
|
10.8 percentage of lens area
Standard Deviation 14.5
|
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 120974A
n=71 Participants
Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
Boston Simplus
n=35 Participants
Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
|
|---|---|---|
|
Film Deposit Area Covered
Day 7, n=40, 15
|
23.8 percentage of lens area
Standard Deviation 17.2
|
22.7 percentage of lens area
Standard Deviation 13.7
|
|
Film Deposit Area Covered
Day 30, n=47, 20
|
26.2 percentage of lens area
Standard Deviation 22.0
|
28.4 percentage of lens area
Standard Deviation 21.1
|
|
Film Deposit Area Covered
Day 60, n=47, 20
|
26.4 percentage of lens area
Standard Deviation 17.5
|
24.0 percentage of lens area
Standard Deviation 11.0
|
|
Film Deposit Area Covered
Day 90, n=45, 24
|
25.3 percentage of lens area
Standard Deviation 13.7
|
28.3 percentage of lens area
Standard Deviation 21.9
|
Adverse Events
Pre-treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FID 120974A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Boston Simplus
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
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