Trial Outcomes & Findings for Clinical Evaluation of the Safety and Efficacy of FID 120947A (NCT NCT02771145)
NCT ID: NCT02771145
Last Updated: 2019-01-10
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. Both eyes contributed to the analysis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
91 participants
Primary outcome timeframe
Day 7, Day 30, Day 60, Day 90, Day 135, Day 180
Results posted on
2019-01-10
Participant Flow
Subjects were recruited from 6 study centers located in Japan.
Of the 91 enrolled, 1 subject was exited as a screen failure prior to treatment. This reporting group includes all treated subjects (90).
Participant milestones
| Measure |
FID 120947A
FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
|
|---|---|
|
Overall Study
STARTED
|
90
|
|
Overall Study
COMPLETED
|
86
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
FID 120947A
FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Clinical Evaluation of the Safety and Efficacy of FID 120947A
Baseline characteristics by cohort
| Measure |
FID 120947A
n=90 Participants
FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
|
|---|---|
|
Age, Continuous
|
32.1 years
STANDARD_DEVIATION 9.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180Population: Full Analysis Set, with non-missing response
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. Both eyes contributed to the analysis.
Outcome measures
| Measure |
FID 120947A
n=180 Eyes
FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
|
Type III
Films or deposits readily visible on a dry lens under room lighting, with unaided eye
|
Type IV
Films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry
|
No Change
|
1 Line Decrease
|
2 Line Decrease
|
≥3 Line Decrease
|
|---|---|---|---|---|---|---|---|
|
Percentage of Eyes With Visibly Clean Lenses at Each Visit
Day 7
|
92.2 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Visibly Clean Lenses at Each Visit
Day 30
|
88.2 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Visibly Clean Lenses at Each Visit
Day 60
|
95.5 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Visibly Clean Lenses at Each Visit
Day 90
|
92.5 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Visibly Clean Lenses at Each Visit
Day 135
|
95.2 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Eyes With Visibly Clean Lenses at Each Visit
Day 180
|
95.9 percentage of eyes
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180Population: Full Analysis Set
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. Both eyes contributed to the analysis.
Outcome measures
| Measure |
FID 120947A
n=180 Eyes
FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
|
Type III
n=180 Eyes
Films or deposits readily visible on a dry lens under room lighting, with unaided eye
|
Type IV
n=180 Eyes
Films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry
|
No Change
|
1 Line Decrease
|
2 Line Decrease
|
≥3 Line Decrease
|
|---|---|---|---|---|---|---|---|
|
Number of Eyes With Film Deposits on Lens by Type at Each Visit
Day 7
|
0 eyes
|
3 eyes
|
1 eyes
|
—
|
—
|
—
|
—
|
|
Number of Eyes With Film Deposits on Lens by Type at Each Visit
Day 30
|
3 eyes
|
0 eyes
|
4 eyes
|
—
|
—
|
—
|
—
|
|
Number of Eyes With Film Deposits on Lens by Type at Each Visit
Day 60
|
1 eyes
|
0 eyes
|
3 eyes
|
—
|
—
|
—
|
—
|
|
Number of Eyes With Film Deposits on Lens by Type at Each Visit
Day 90
|
1 eyes
|
1 eyes
|
2 eyes
|
—
|
—
|
—
|
—
|
|
Number of Eyes With Film Deposits on Lens by Type at Each Visit
Day 135
|
2 eyes
|
1 eyes
|
2 eyes
|
—
|
—
|
—
|
—
|
|
Number of Eyes With Film Deposits on Lens by Type at Each Visit
Day 180
|
1 eyes
|
0 eyes
|
1 eyes
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180Population: Full Analysis Set
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. Both eyes contributed to the analysis.
Outcome measures
| Measure |
FID 120947A
n=180 Eyes
FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
|
Type III
n=180 Eyes
Films or deposits readily visible on a dry lens under room lighting, with unaided eye
|
Type IV
n=180 Eyes
Films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry
|
No Change
|
1 Line Decrease
|
2 Line Decrease
|
≥3 Line Decrease
|
|---|---|---|---|---|---|---|---|
|
Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit
Day 7
|
4 eyes
|
8 eyes
|
2 eyes
|
—
|
—
|
—
|
—
|
|
Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit
Day 30
|
5 eyes
|
4 eyes
|
8 eyes
|
—
|
—
|
—
|
—
|
|
Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit
Day 60
|
0 eyes
|
0 eyes
|
4 eyes
|
—
|
—
|
—
|
—
|
|
Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit
Day 90
|
1 eyes
|
0 eyes
|
10 eyes
|
—
|
—
|
—
|
—
|
|
Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit
Day 135
|
0 eyes
|
0 eyes
|
3 eyes
|
—
|
—
|
—
|
—
|
|
Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit
Day 180
|
0 eyes
|
0 eyes
|
5 eyes
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180Population: Full Analysis Set
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. For each visit, the number analyzed represents the number of eyes with film deposits on lens, respectively.
Outcome measures
| Measure |
FID 120947A
n=180 eyes
FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
|
Type III
Films or deposits readily visible on a dry lens under room lighting, with unaided eye
|
Type IV
Films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry
|
No Change
|
1 Line Decrease
|
2 Line Decrease
|
≥3 Line Decrease
|
|---|---|---|---|---|---|---|---|
|
Percentage of Lens Area Covered by Film Deposits at Each Visit
Day 7
|
7.5 percentage of lens area
Standard Deviation 2.89
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Lens Area Covered by Film Deposits at Each Visit
Day 30
|
28.6 percentage of lens area
Standard Deviation 14.92
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Lens Area Covered by Film Deposits at Each Visit
Day 60
|
17.5 percentage of lens area
Standard Deviation 15.00
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Lens Area Covered by Film Deposits at Each Visit
Day 90
|
15.0 percentage of lens area
Standard Deviation 10.00
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Lens Area Covered by Film Deposits at Each Visit
Day 135
|
6.0 percentage of lens area
Standard Deviation 2.24
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Lens Area Covered by Film Deposits at Each Visit
Day 180
|
7.5 percentage of lens area
Standard Deviation 3.54
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180Population: Full Analysis Set
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. For each visit, the number analyzed represents the number of eyes with film deposits on lens, respectively.
Outcome measures
| Measure |
FID 120947A
n=180 Eyes
FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
|
Type III
Films or deposits readily visible on a dry lens under room lighting, with unaided eye
|
Type IV
Films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry
|
No Change
|
1 Line Decrease
|
2 Line Decrease
|
≥3 Line Decrease
|
|---|---|---|---|---|---|---|---|
|
Percentage of Lens Area Covered by Crystalline Deposits at Each Visit
Day 7
|
10.4 percentage of lens area
Standard Deviation 7.90
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Lens Area Covered by Crystalline Deposits at Each Visit
Day 30
|
10.8 percentage of lens area
Standard Deviation 9.65
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Lens Area Covered by Crystalline Deposits at Each Visit
Day 60
|
8.8 percentage of lens area
Standard Deviation 2.50
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Lens Area Covered by Crystalline Deposits at Each Visit
Day 90
|
7.1 percentage of lens area
Standard Deviation 3.45
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Lens Area Covered by Crystalline Deposits at Each Visit
Day 135
|
11.7 percentage of lens area
Standard Deviation 7.64
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Lens Area Covered by Crystalline Deposits at Each Visit
Day 180
|
13.0 percentage of lens area
Standard Deviation 9.75
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7, Day 30, Day 60, Day 90, Day 135, Day 180Population: Full Analysis Set, with non-missing response
Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using Decimal acuity, where 1.0 (equivalent to 20/20) is considered normal distance-eyesight. A line increase indicates an improvement in VA. Both eyes contributed to the analysis
Outcome measures
| Measure |
FID 120947A
n=180 Eyes
FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
|
Type III
n=180 Eyes
Films or deposits readily visible on a dry lens under room lighting, with unaided eye
|
Type IV
n=180 Eyes
Films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry
|
No Change
n=180 Eyes
|
1 Line Decrease
n=180 Eyes
|
2 Line Decrease
n=180 Eyes
|
≥3 Line Decrease
n=180 Eyes
|
|---|---|---|---|---|---|---|---|
|
Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit
Day 7
|
0.6 percentage of eyes
|
0.6 percentage of eyes
|
6.2 percentage of eyes
|
90.4 percentage of eyes
|
1.7 percentage of eyes
|
0.6 percentage of eyes
|
0.0 percentage of eyes
|
|
Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit
Day 30
|
1.7 percentage of eyes
|
3.4 percentage of eyes
|
7.3 percentage of eyes
|
84.8 percentage of eyes
|
2.8 percentage of eyes
|
0.0 percentage of eyes
|
0.0 percentage of eyes
|
|
Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit
Day 60
|
1.7 percentage of eyes
|
3.4 percentage of eyes
|
10.7 percentage of eyes
|
79.2 percentage of eyes
|
3.9 percentage of eyes
|
1.1 percentage of eyes
|
0.0 percentage of eyes
|
|
Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit
Day 90
|
0.0 percentage of eyes
|
3.4 percentage of eyes
|
11.5 percentage of eyes
|
79.9 percentage of eyes
|
4.6 percentage of eyes
|
0.6 percentage of eyes
|
0.0 percentage of eyes
|
|
Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit
Day 135
|
1.8 percentage of eyes
|
3.0 percentage of eyes
|
8.3 percentage of eyes
|
77.4 percentage of eyes
|
8.9 percentage of eyes
|
0.6 percentage of eyes
|
0.0 percentage of eyes
|
|
Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit
Day 180
|
1.2 percentage of eyes
|
2.3 percentage of eyes
|
9.9 percentage of eyes
|
75.6 percentage of eyes
|
8.1 percentage of eyes
|
1.7 percentage of eyes
|
1.2 percentage of eyes
|
PRIMARY outcome
Timeframe: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180Population: Full Analysis Set, with non-missing response
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 summarized as an estimate of the subject's daily wear, averaged over the course of 3 days prior to each scheduled visit, and measured in hours. Habitual lenses were used at the Day 0 time point.
Outcome measures
| Measure |
FID 120947A
n=90 Participants
FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
|
Type III
Films or deposits readily visible on a dry lens under room lighting, with unaided eye
|
Type IV
Films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry
|
No Change
|
1 Line Decrease
|
2 Line Decrease
|
≥3 Line Decrease
|
|---|---|---|---|---|---|---|---|
|
Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit
Day 0
|
12.4 hours
Standard Deviation 2.54
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit
Day 7
|
11.9 hours
Standard Deviation 2.58
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit
Day 30
|
12.0 hours
Standard Deviation 2.50
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit
Day 60
|
11.8 hours
Standard Deviation 2.53
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit
Day 90
|
11.7 hours
Standard Deviation 2.73
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit
Day 135
|
11.9 hours
Standard Deviation 2.78
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit
Day 180
|
11.8 hours
Standard Deviation 2.57
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180Population: Full Analysis Set, with non-missing response
Subject recorded a response to the question, "How many hours have you worn your contact lenses today?" Lens wear was measured in hours. Habitual lenses were used at the Day 0 time point.
Outcome measures
| Measure |
FID 120947A
n=90 Participants
FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
|
Type III
Films or deposits readily visible on a dry lens under room lighting, with unaided eye
|
Type IV
Films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry
|
No Change
|
1 Line Decrease
|
2 Line Decrease
|
≥3 Line Decrease
|
|---|---|---|---|---|---|---|---|
|
Lens Wear Time at Each Visit Day
Day 0
|
4.3 hours
Standard Deviation 3.53
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Lens Wear Time at Each Visit Day
Day 7
|
4.8 hours
Standard Deviation 3.53
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Lens Wear Time at Each Visit Day
Day 30
|
4.7 hours
Standard Deviation 3.27
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Lens Wear Time at Each Visit Day
Day 60
|
4.2 hours
Standard Deviation 3.04
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Lens Wear Time at Each Visit Day
Day 90
|
4.4 hours
Standard Deviation 3.33
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Lens Wear Time at Each Visit Day
Day 135
|
4.4 hours
Standard Deviation 3.28
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Lens Wear Time at Each Visit Day
Day 180
|
4.6 hours
Standard Deviation 3.35
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180Population: Full Analysis Set, with non-missing response
Subject recorded a response to the question, "Averaging over the last 3 days, how many times per day did you use rewetting drops?" Habitual lenses were used at the Day 0 time point.
Outcome measures
| Measure |
FID 120947A
n=90 Participants
FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
|
Type III
Films or deposits readily visible on a dry lens under room lighting, with unaided eye
|
Type IV
Films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry
|
No Change
|
1 Line Decrease
|
2 Line Decrease
|
≥3 Line Decrease
|
|---|---|---|---|---|---|---|---|
|
Average Rewetting Drop Frequency at Each Visit
Day 0
|
0.3 times per day
Standard Deviation 1.11
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Average Rewetting Drop Frequency at Each Visit
Day 7
|
1.4 times per day
Standard Deviation 2.27
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Average Rewetting Drop Frequency at Each Visit
Day 30
|
1.7 times per day
Standard Deviation 1.85
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Average Rewetting Drop Frequency at Each Visit
Day 60
|
1.6 times per day
Standard Deviation 1.79
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Average Rewetting Drop Frequency at Each Visit
Day 90
|
1.7 times per day
Standard Deviation 1.93
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Average Rewetting Drop Frequency at Each Visit
Day 135
|
1.8 times per day
Standard Deviation 1.97
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Average Rewetting Drop Frequency at Each Visit
Day 180
|
1.7 times per day
Standard Deviation 2.00
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 180Population: Full Analysis Set, with specified reason for replacement.
Subjects were dispensed enough contact lenses to follow a 2-week replacement schedule during the study. 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. All lenses which were replaced are counted. Habitual lenses were used at the Day 0 time point.
Outcome measures
| Measure |
FID 120947A
n=90 Participants
FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
|
Type III
Films or deposits readily visible on a dry lens under room lighting, with unaided eye
|
Type IV
Films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry
|
No Change
|
1 Line Decrease
|
2 Line Decrease
|
≥3 Line Decrease
|
|---|---|---|---|---|---|---|---|
|
Number of Unscheduled Lens Replacements by Reason
Unplanned - Lens torn on eye
|
5 lenses
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Unscheduled Lens Replacements by Reason
Unplanned - Lens torn while handling
|
38 lenses
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Unscheduled Lens Replacements by Reason
Unplanned - Lens deposit
|
17 lenses
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Unscheduled Lens Replacements by Reason
Unplanned - Bad edge
|
4 lenses
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Unscheduled Lens Replacements by Reason
Unplanned - Bad surface
|
0 lenses
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Unscheduled Lens Replacements by Reason
Unplanned - Discoloration
|
0 lenses
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Unscheduled Lens Replacements by Reason
Unplanned - No lens in pack
|
0 lenses
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Unscheduled Lens Replacements by Reason
Unplanned - Visual Acuity
|
2 lenses
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Unscheduled Lens Replacements by Reason
Unplanned - Discomfort
|
6 lenses
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Unscheduled Lens Replacements by Reason
Unplanned - Pathology
|
0 lenses
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Unscheduled Lens Replacements by Reason
Unplanned - Lost
|
7 lenses
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Unscheduled Lens Replacements by Reason
Other
|
2 lenses
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180Population: Full Analysis Set
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. Habitual lenses and habitual lens care solution were used at the Day 0 time point.
Outcome measures
| Measure |
FID 120947A
n=90 Participants
FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
|
Type III
n=90 Participants
Films or deposits readily visible on a dry lens under room lighting, with unaided eye
|
Type IV
n=90 Participants
Films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry
|
No Change
n=90 Participants
|
1 Line Decrease
n=90 Participants
|
2 Line Decrease
|
≥3 Line Decrease
|
|---|---|---|---|---|---|---|---|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 0
|
26.7 percentage of subjects
|
44.4 percentage of subjects
|
22.2 percentage of subjects
|
6.7 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 7
|
35.6 percentage of subjects
|
41.1 percentage of subjects
|
15.6 percentage of subjects
|
7.8 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 30
|
29.2 percentage of subjects
|
48.3 percentage of subjects
|
13.5 percentage of subjects
|
9.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 60
|
34.8 percentage of subjects
|
46.1 percentage of subjects
|
14.6 percentage of subjects
|
4.5 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 90
|
36.0 percentage of subjects
|
49.4 percentage of subjects
|
11.2 percentage of subjects
|
2.2 percentage of subjects
|
1.1 percentage of subjects
|
—
|
—
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 135
|
38.8 percentage of subjects
|
44.7 percentage of subjects
|
16.5 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
|
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
Day 180
|
41.9 percentage of subjects
|
50.0 percentage of subjects
|
8.1 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180Population: Full Analysis Set with non-missing response
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. Habitual lenses and habitual lens care solution were used at the Day 0 time point.
Outcome measures
| Measure |
FID 120947A
n=90 Participants
FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
|
Type III
n=90 Participants
Films or deposits readily visible on a dry lens under room lighting, with unaided eye
|
Type IV
n=90 Participants
Films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry
|
No Change
n=90 Participants
|
1 Line Decrease
n=90 Participants
|
2 Line Decrease
|
≥3 Line Decrease
|
|---|---|---|---|---|---|---|---|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 0
|
42.2 percentage of subjects
|
38.9 percentage of subjects
|
12.2 percentage of subjects
|
5.6 percentage of subjects
|
1.1 percentage of subjects
|
—
|
—
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 7
|
48.9 percentage of subjects
|
37.8 percentage of subjects
|
10.0 percentage of subjects
|
3.3 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
|
46.1 percentage of subjects
|
37.1 percentage of subjects
|
14.6 percentage of subjects
|
2.2 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
|
42.7 percentage of subjects
|
41.6 percentage of subjects
|
13.5 percentage of subjects
|
2.2 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
|
39.3 percentage of subjects
|
47.2 percentage of subjects
|
13.5 percentage of subjects
|
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 135
|
41.2 percentage of subjects
|
47.1 percentage of subjects
|
10.6 percentage of subjects
|
0.0 percentage of subjects
|
1.2 percentage of subjects
|
—
|
—
|
|
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
Day 180
|
44.2 percentage of subjects
|
48.8 percentage of subjects
|
7.0 percentage of subjects
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180Population: Full Analysis Set with non-missing response
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. Habitual lenses and habitual lens care solution were used at the Day 0 time point.
Outcome measures
| Measure |
FID 120947A
n=90 Participants
FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.
|
Type III
n=90 Participants
Films or deposits readily visible on a dry lens under room lighting, with unaided eye
|
Type IV
n=90 Participants
Films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry
|
No Change
n=90 Participants
|
1 Line Decrease
n=90 Participants
|
2 Line Decrease
|
≥3 Line Decrease
|
|---|---|---|---|---|---|---|---|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 0
|
44.4 percentage of subjects
|
41.1 percentage of subjects
|
12.2 percentage of subjects
|
2.2 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
|
28.9 percentage of subjects
|
32.2 percentage of subjects
|
25.6 percentage of subjects
|
12.2 percentage of subjects
|
1.1 percentage of subjects
|
—
|
—
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 30
|
31.5 percentage of subjects
|
39.3 percentage of subjects
|
19.1 percentage of subjects
|
7.9 percentage of subjects
|
2.2 percentage of subjects
|
—
|
—
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 60
|
25.8 percentage of subjects
|
40.4 percentage of subjects
|
27.0 percentage of subjects
|
5.6 percentage of subjects
|
1.1 percentage of subjects
|
—
|
—
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 90
|
30.3 percentage of subjects
|
41.6 percentage of subjects
|
22.5 percentage of subjects
|
3.4 percentage of subjects
|
2.2 percentage of subjects
|
—
|
—
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 135
|
29.4 percentage of subjects
|
44.7 percentage of subjects
|
21.2 percentage of subjects
|
2.4 percentage of subjects
|
2.4 percentage of subjects
|
—
|
—
|
|
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
Day 180
|
34.9 percentage of subjects
|
40.7 percentage of subjects
|
19.8 percentage of subjects
|
2.3 percentage of subjects
|
2.3 percentage of subjects
|
—
|
—
|
Adverse Events
FID 120977A - Subject Based Adverse Events
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FID 120977A - Ocular Adverse Events
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FID 120977A - Subject Based Adverse Events
n=90 participants at risk
All subjects treated with FID 120947A contact lens disinfecting solution
|
FID 120977A - Ocular Adverse Events
n=180 participants at risk
All eyes treated with FID 120947A contact lens disinfecting solution
|
|---|---|---|
|
Eye disorders
Eye irritation
|
0.00%
0/90 • Day 1 through study completion, an average of 6 months
An AE was defined as any unfavorable or unintended sign, symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
6.1%
11/180 • Day 1 through study completion, an average of 6 months
An AE was defined as any unfavorable or unintended sign, symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Vision blurred
|
0.00%
0/90 • Day 1 through study completion, an average of 6 months
An AE was defined as any unfavorable or unintended sign, symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
10.0%
18/180 • Day 1 through study completion, an average of 6 months
An AE was defined as any unfavorable or unintended sign, symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
Additional Information
Sr. Clinical Project Lead, GCRA, Vision Care
Alcon, A Novartis Division
Phone: 1-888-451-3937
Email: [email protected]
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