Vision Satisfaction in Bright Light
Conditions
Brief summary
This registry study is a one-year, one-visit, observational, prospective, open-label, two-arm, multi-center, multi-national, post-market study of approximately 300 patients who have recently been fitted with the ACUVUE® OASYS with Transitions™ and approximately 300 patients who have recently been fitted with spherical nonphotochromic reusable marketed silicone hydrogel contact lenses (of any brand). Eligible subjects will be asked to complete a Patient Registration Questionnaire several times throughout the year.
Interventions
JJVC Marketed Contact Lens
Any reusable spherical silicone hydrogel brand that is approved and marketed in the country conducting the study.
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- Potential subjects must satisfy all of the following criteria to be enrolled in the study: * Contact lens neophytes or those who have recently (i.e. within last 2 months) begun the use of a new lens type and have purchased a supply of lenses. * A minimum age of 18 years, with no maximum age. * The registrant must read and sign the Informed Consent form. * The registrant must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion criteria
\- Potential subjects who meet any of the following criteria will be excluded from participating in the study: * Current participant in another research study. * Employee or relative of site, or family member of Recruiting Practitioner or Johnson & Johnson. * Non-spherical contact lens wearers, i.e. toric or multifocal lenses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vision Satisfaction in Bright Lighting - 2-Week Questionnaire | 2-week questionnaire follow-up | Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level of agreement with the statement I am satisfied with the quality of my vision in bright lighting with these contact lenses using a 5-point agreement Likert scale (Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree). In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for the primary endpoint data summary. The number of missing responses in each lens group was reported. |
| Vision Satisfaction in Bright Lighting - 4-Month Questionnaire | 4-month questionnaire follow-up | Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level of agreement with the statement I am satisfied with the quality of my vision in bright lighting with these contact lenses using a 5-point agreement Likert scale (Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree). In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for the primary endpoint data summary. The number of missing responses in each lens group was reported. |
| Vision Satisfaction in Bright Lighting - 12-Month Questionnaire | 12-month questionnaire follow-up | Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level of agreement with the statement I am satisfied with the quality of my vision in bright lighting with these contact lenses using a 5-point agreement Likert scale (Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree). In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for the primary endpoint data summary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort - 2-Week Questionnaire | 2-week questionnaire follow-up | Overall comfort was assessed using the item How would you rate the overall comfort of these contact lenses?. The item used the 5-point excellence scale, Excellent, Very Good, Good, Fair, and Poor. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported. |
| Overall Comfort - 4-Month Questionnaire | 4-month questionnaire follow-up | Overall comfort was assessed using the item How would you rate the overall comfort of these contact lenses?. The item used the 5-point excellence scale, Excellent, Very Good, Good, Fair, and Poor. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported. |
| Overall Quality of Vision - 2-Week Questionnaire | 2-week questionnaire follow-up | Overall quality of vision was assessed subjectively using the item I am satisfied with the overall quality of my vision with these contact lenses. The item used a 5-point agreement scale: Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported. |
| Pulfrich Effect | 2-week, 4-month, and 12-month questionnaire follow-up | Pulfrich effect was assessed subjectively using the item While wearing these lenses, my depth perception of moving objects has NOT been impacted. Subjects who disagreed or strongly disagreed with the statement were considered to have experienced the Pulfrich effect. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. |
| Serious or Significant Adverse Events | Throughout the duration of the study, up to 12 months | A serious adverse event is any untoward medical occurrence that is potentially sight-threatening, requires hospitalization, results in persistent or significant disability / incapacity, or requires intervention to prevent permanent damage. Significant adverse events are usually symptomatic and warrant discontinuation (temporary or permanent) of the test article (excluding serious adverse events). |
| Overall Comfort - 12-Month Questionnaire | 12-month questionnaire follow-up | Overall comfort was assessed using the item How would you rate the overall comfort of these contact lenses?. The item used the 5-point excellence scale, Excellent, Very Good, Good, Fair, and Poor. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported. |
| Overall Quality of Vision - 4-Month Questionnaire | 4-month questionnaire follow-up | Overall quality of vision was assessed subjectively using the item I am satisfied with the overall quality of my vision with these contact lenses. The item used a 5-point agreement scale: Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported. |
| Overall Quality of Vision - 12-Month Questionnaire | 12-month questionnaire follow-up | Overall quality of vision was assessed subjectively using the item I am satisfied with the overall quality of my vision with these contact lenses. The item used a 5-point agreement scale: Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported. |
Countries
Spain, United Kingdom
Participant flow
Recruitment details
A total of 146 subjects were enrolled in this study. All 146 subjects (88 in the Test group and 58 in the Control group) were deemed eligible at the screening visit. In the Control group 4 subjects were later identified as ineligible (enrolled in error), as they were wearing ineligible Control lenses. Of those enrolled, 113 subjects completed the study while 33 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Test Patients who had recently been fitted with ACUVUE® OASYS with Transitions™ | 88 |
| Control Patients who had recently been fitted with spherical non-photochromic reusable marketed silicone hydrogel contact lenses of any brand. | 58 |
| Total | 146 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | PI confirmed subject was not over 18 when enrolled in study. Subject discontinued | 1 | 0 |
| Overall Study | Subject did not like the lenses graduation change | 1 | 0 |
| Overall Study | Subject no longer meets eligibility criteria | 1 | 4 |
| Overall Study | Subject stopped wearing study lenses after 2 weeks due to dryness | 1 | 0 |
| Overall Study | Subject was enrolled in error | 2 | 0 |
| Overall Study | Subject withdrawn due to non-compliance to protocol | 11 | 7 |
| Overall Study | Switched to a different type of contact lens due to discomfort and dryness | 1 | 0 |
| Overall Study | Withdrew consent during study | 3 | 1 |
Baseline characteristics
| Characteristic | Test | Control | Total |
|---|---|---|---|
| Age, Continuous | 33.9 Years STANDARD_DEVIATION 11.93 | 31.9 Years STANDARD_DEVIATION 12.09 | 33.1 Years STANDARD_DEVIATION 11.99 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Spain | 64 Participants | 50 Participants | 114 Participants |
| Region of Enrollment United Kingdom | 24 Participants | 8 Participants | 32 Participants |
| Sex: Female, Male Female | 51 Participants | 40 Participants | 91 Participants |
| Sex: Female, Male Male | 37 Participants | 18 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 88 | 0 / 58 |
| other Total, other adverse events | 0 / 88 | 0 / 58 |
| serious Total, serious adverse events | 0 / 88 | 0 / 58 |
Outcome results
Primary
Vision Satisfaction in Bright Lighting - 12-Month Questionnaire
Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level of agreement with the statement I am satisfied with the quality of my vision in bright lighting with these contact lenses using a 5-point agreement Likert scale (Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree). In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for the primary endpoint data summary.
Time frame: 12-month questionnaire follow-up
Population: All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing responses was reported for each endpoint at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test | Vision Satisfaction in Bright Lighting - 12-Month Questionnaire | Strongly Agree | 23 Responses |
| Test | Vision Satisfaction in Bright Lighting - 12-Month Questionnaire | Agree | 29 Responses |
| Test | Vision Satisfaction in Bright Lighting - 12-Month Questionnaire | Neither Agree Nor Disagree | 4 Responses |
| Test | Vision Satisfaction in Bright Lighting - 12-Month Questionnaire | Disagree | 3 Responses |
| Test | Vision Satisfaction in Bright Lighting - 12-Month Questionnaire | Strongly Disagree | 0 Responses |
| Test | Vision Satisfaction in Bright Lighting - 12-Month Questionnaire | Missing Response (Subject didn't answer the item) | 29 Responses |
| Control | Vision Satisfaction in Bright Lighting - 12-Month Questionnaire | Strongly Disagree | 0 Responses |
| Control | Vision Satisfaction in Bright Lighting - 12-Month Questionnaire | Strongly Agree | 22 Responses |
| Control | Vision Satisfaction in Bright Lighting - 12-Month Questionnaire | Disagree | 0 Responses |
| Control | Vision Satisfaction in Bright Lighting - 12-Month Questionnaire | Agree | 21 Responses |
| Control | Vision Satisfaction in Bright Lighting - 12-Month Questionnaire | Missing Response (Subject didn't answer the item) | 9 Responses |
| Control | Vision Satisfaction in Bright Lighting - 12-Month Questionnaire | Neither Agree Nor Disagree | 2 Responses |
Primary
Vision Satisfaction in Bright Lighting - 2-Week Questionnaire
Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level of agreement with the statement I am satisfied with the quality of my vision in bright lighting with these contact lenses using a 5-point agreement Likert scale (Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree). In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for the primary endpoint data summary. The number of missing responses in each lens group was reported.
Time frame: 2-week questionnaire follow-up
Population: All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing responses was reported for each endpoint at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test | Vision Satisfaction in Bright Lighting - 2-Week Questionnaire | Strongly Agree | 33 Responses |
| Test | Vision Satisfaction in Bright Lighting - 2-Week Questionnaire | Agree | 33 Responses |
| Test | Vision Satisfaction in Bright Lighting - 2-Week Questionnaire | Neither Agree Nor Disagree | 10 Responses |
| Test | Vision Satisfaction in Bright Lighting - 2-Week Questionnaire | Disagree | 2 Responses |
| Test | Vision Satisfaction in Bright Lighting - 2-Week Questionnaire | Strongly Disagree | 0 Responses |
| Test | Vision Satisfaction in Bright Lighting - 2-Week Questionnaire | Missing Response (Subject didn't answer the item) | 10 Responses |
| Control | Vision Satisfaction in Bright Lighting - 2-Week Questionnaire | Strongly Disagree | 0 Responses |
| Control | Vision Satisfaction in Bright Lighting - 2-Week Questionnaire | Strongly Agree | 21 Responses |
| Control | Vision Satisfaction in Bright Lighting - 2-Week Questionnaire | Disagree | 0 Responses |
| Control | Vision Satisfaction in Bright Lighting - 2-Week Questionnaire | Agree | 24 Responses |
| Control | Vision Satisfaction in Bright Lighting - 2-Week Questionnaire | Missing Response (Subject didn't answer the item) | 7 Responses |
| Control | Vision Satisfaction in Bright Lighting - 2-Week Questionnaire | Neither Agree Nor Disagree | 2 Responses |
Primary
Vision Satisfaction in Bright Lighting - 4-Month Questionnaire
Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level of agreement with the statement I am satisfied with the quality of my vision in bright lighting with these contact lenses using a 5-point agreement Likert scale (Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree). In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for the primary endpoint data summary. The number of missing responses in each lens group was reported.
Time frame: 4-month questionnaire follow-up
Population: all subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing responses was reported for each endpoint at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test | Vision Satisfaction in Bright Lighting - 4-Month Questionnaire | Agree | 38 Responses |
| Test | Vision Satisfaction in Bright Lighting - 4-Month Questionnaire | Disagree | 2 Responses |
| Test | Vision Satisfaction in Bright Lighting - 4-Month Questionnaire | Strongly Agree | 24 Responses |
| Test | Vision Satisfaction in Bright Lighting - 4-Month Questionnaire | Neither Agree Nor Disagree | 7 Responses |
| Test | Vision Satisfaction in Bright Lighting - 4-Month Questionnaire | Missing Response (Subject didn't answer the item) | 17 Responses |
| Test | Vision Satisfaction in Bright Lighting - 4-Month Questionnaire | Strongly Disagree | 0 Responses |
| Control | Vision Satisfaction in Bright Lighting - 4-Month Questionnaire | Missing Response (Subject didn't answer the item) | 7 Responses |
| Control | Vision Satisfaction in Bright Lighting - 4-Month Questionnaire | Strongly Agree | 20 Responses |
| Control | Vision Satisfaction in Bright Lighting - 4-Month Questionnaire | Agree | 25 Responses |
| Control | Vision Satisfaction in Bright Lighting - 4-Month Questionnaire | Neither Agree Nor Disagree | 2 Responses |
| Control | Vision Satisfaction in Bright Lighting - 4-Month Questionnaire | Disagree | 0 Responses |
| Control | Vision Satisfaction in Bright Lighting - 4-Month Questionnaire | Strongly Disagree | 0 Responses |
Secondary
Overall Comfort - 12-Month Questionnaire
Overall comfort was assessed using the item How would you rate the overall comfort of these contact lenses?. The item used the 5-point excellence scale, Excellent, Very Good, Good, Fair, and Poor. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported.
Time frame: 12-month questionnaire follow-up
Population: All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing data was reported for each endpoint at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test | Overall Comfort - 12-Month Questionnaire | Excellent | 20 Responses |
| Test | Overall Comfort - 12-Month Questionnaire | Very Good | 28 Responses |
| Test | Overall Comfort - 12-Month Questionnaire | Good | 8 Responses |
| Test | Overall Comfort - 12-Month Questionnaire | Fair | 2 Responses |
| Test | Overall Comfort - 12-Month Questionnaire | Poor | 1 Responses |
| Test | Overall Comfort - 12-Month Questionnaire | Missing Response (Subject didn't answer the item) | 29 Responses |
| Control | Overall Comfort - 12-Month Questionnaire | Poor | 1 Responses |
| Control | Overall Comfort - 12-Month Questionnaire | Excellent | 10 Responses |
| Control | Overall Comfort - 12-Month Questionnaire | Fair | 2 Responses |
| Control | Overall Comfort - 12-Month Questionnaire | Very Good | 23 Responses |
| Control | Overall Comfort - 12-Month Questionnaire | Missing Response (Subject didn't answer the item) | 9 Responses |
| Control | Overall Comfort - 12-Month Questionnaire | Good | 9 Responses |
Secondary
Overall Comfort - 2-Week Questionnaire
Overall comfort was assessed using the item How would you rate the overall comfort of these contact lenses?. The item used the 5-point excellence scale, Excellent, Very Good, Good, Fair, and Poor. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported.
Time frame: 2-week questionnaire follow-up
Population: All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing data was reported for each endpoint at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test | Overall Comfort - 2-Week Questionnaire | Excellent | 19 Responses |
| Test | Overall Comfort - 2-Week Questionnaire | Very Good | 37 Responses |
| Test | Overall Comfort - 2-Week Questionnaire | Good | 17 Responses |
| Test | Overall Comfort - 2-Week Questionnaire | Fair | 4 Responses |
| Test | Overall Comfort - 2-Week Questionnaire | Poor | 0 Responses |
| Test | Overall Comfort - 2-Week Questionnaire | Missing Response (Subject didn't answer the item) | 11 Responses |
| Control | Overall Comfort - 2-Week Questionnaire | Poor | 0 Responses |
| Control | Overall Comfort - 2-Week Questionnaire | Excellent | 9 Responses |
| Control | Overall Comfort - 2-Week Questionnaire | Fair | 1 Responses |
| Control | Overall Comfort - 2-Week Questionnaire | Very Good | 28 Responses |
| Control | Overall Comfort - 2-Week Questionnaire | Missing Response (Subject didn't answer the item) | 7 Responses |
| Control | Overall Comfort - 2-Week Questionnaire | Good | 9 Responses |
Secondary
Overall Comfort - 4-Month Questionnaire
Overall comfort was assessed using the item How would you rate the overall comfort of these contact lenses?. The item used the 5-point excellence scale, Excellent, Very Good, Good, Fair, and Poor. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported.
Time frame: 4-month questionnaire follow-up
Population: All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing data was reported for each endpoint at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test | Overall Comfort - 4-Month Questionnaire | Excellent | 27 Responses |
| Test | Overall Comfort - 4-Month Questionnaire | Very Good | 25 Responses |
| Test | Overall Comfort - 4-Month Questionnaire | Good | 12 Responses |
| Test | Overall Comfort - 4-Month Questionnaire | Fair | 6 Responses |
| Test | Overall Comfort - 4-Month Questionnaire | Poor | 1 Responses |
| Test | Overall Comfort - 4-Month Questionnaire | Missing Response (Subject didn't answer the item) | 17 Responses |
| Control | Overall Comfort - 4-Month Questionnaire | Poor | 1 Responses |
| Control | Overall Comfort - 4-Month Questionnaire | Excellent | 16 Responses |
| Control | Overall Comfort - 4-Month Questionnaire | Fair | 2 Responses |
| Control | Overall Comfort - 4-Month Questionnaire | Very Good | 19 Responses |
| Control | Overall Comfort - 4-Month Questionnaire | Missing Response (Subject didn't answer the item) | 7 Responses |
| Control | Overall Comfort - 4-Month Questionnaire | Good | 9 Responses |
Secondary
Overall Quality of Vision - 12-Month Questionnaire
Overall quality of vision was assessed subjectively using the item I am satisfied with the overall quality of my vision with these contact lenses. The item used a 5-point agreement scale: Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported.
Time frame: 12-month questionnaire follow-up
Population: All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing data was reported for each endpoint at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test | Overall Quality of Vision - 12-Month Questionnaire | Agree | 30 Responses |
| Test | Overall Quality of Vision - 12-Month Questionnaire | Strongly Agree | 25 Responses |
| Test | Overall Quality of Vision - 12-Month Questionnaire | Neither Agree Nor Disagree | 1 Responses |
| Test | Overall Quality of Vision - 12-Month Questionnaire | Disagree | 3 Responses |
| Test | Overall Quality of Vision - 12-Month Questionnaire | Strongly Disagree | 0 Responses |
| Test | Overall Quality of Vision - 12-Month Questionnaire | Missing Response (Subject didn't answer the item) | 29 Responses |
| Control | Overall Quality of Vision - 12-Month Questionnaire | Strongly Disagree | 0 Responses |
| Control | Overall Quality of Vision - 12-Month Questionnaire | Disagree | 0 Responses |
| Control | Overall Quality of Vision - 12-Month Questionnaire | Strongly Agree | 18 Responses |
| Control | Overall Quality of Vision - 12-Month Questionnaire | Agree | 25 Responses |
| Control | Overall Quality of Vision - 12-Month Questionnaire | Missing Response (Subject didn't answer the item) | 9 Responses |
| Control | Overall Quality of Vision - 12-Month Questionnaire | Neither Agree Nor Disagree | 2 Responses |
Secondary
Overall Quality of Vision - 2-Week Questionnaire
Overall quality of vision was assessed subjectively using the item I am satisfied with the overall quality of my vision with these contact lenses. The item used a 5-point agreement scale: Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported.
Time frame: 2-week questionnaire follow-up
Population: All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing data was reported for each endpoint at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test | Overall Quality of Vision - 2-Week Questionnaire | Strongly Agree | 37 Responses |
| Test | Overall Quality of Vision - 2-Week Questionnaire | Agree | 36 Responses |
| Test | Overall Quality of Vision - 2-Week Questionnaire | Neither Agree Nor Disagree | 3 Responses |
| Test | Overall Quality of Vision - 2-Week Questionnaire | Disagree | 1 Responses |
| Test | Overall Quality of Vision - 2-Week Questionnaire | Strongly Disagree | 0 Responses |
| Test | Overall Quality of Vision - 2-Week Questionnaire | Missing Response (Subject didn't answer the item) | 11 Responses |
| Control | Overall Quality of Vision - 2-Week Questionnaire | Strongly Disagree | 0 Responses |
| Control | Overall Quality of Vision - 2-Week Questionnaire | Strongly Agree | 27 Responses |
| Control | Overall Quality of Vision - 2-Week Questionnaire | Disagree | 0 Responses |
| Control | Overall Quality of Vision - 2-Week Questionnaire | Agree | 20 Responses |
| Control | Overall Quality of Vision - 2-Week Questionnaire | Missing Response (Subject didn't answer the item) | 7 Responses |
| Control | Overall Quality of Vision - 2-Week Questionnaire | Neither Agree Nor Disagree | 0 Responses |
Secondary
Overall Quality of Vision - 4-Month Questionnaire
Overall quality of vision was assessed subjectively using the item I am satisfied with the overall quality of my vision with these contact lenses. The item used a 5-point agreement scale: Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary. The number of missing responses in each lens group was reported.
Time frame: 4-month questionnaire follow-up
Population: All subjects in the full analysis (FA) population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. In the FA population, 4 out of 58 subjects were identified as ineligible after screening, resulting in 54 in the Control group among the analysis population. A summary of missing data was reported for each endpoint at each timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test | Overall Quality of Vision - 4-Month Questionnaire | Strongly Agree | 31 Responses |
| Test | Overall Quality of Vision - 4-Month Questionnaire | Agree | 35 Responses |
| Test | Overall Quality of Vision - 4-Month Questionnaire | Neither Agree Nor Disagree | 5 Responses |
| Test | Overall Quality of Vision - 4-Month Questionnaire | Disagree | 0 Responses |
| Test | Overall Quality of Vision - 4-Month Questionnaire | Strongly Disagree | 0 Responses |
| Test | Overall Quality of Vision - 4-Month Questionnaire | Missing Response (Subject didn't answer the item) | 17 Responses |
| Control | Overall Quality of Vision - 4-Month Questionnaire | Strongly Disagree | 0 Responses |
| Control | Overall Quality of Vision - 4-Month Questionnaire | Strongly Agree | 22 Responses |
| Control | Overall Quality of Vision - 4-Month Questionnaire | Disagree | 0 Responses |
| Control | Overall Quality of Vision - 4-Month Questionnaire | Agree | 23 Responses |
| Control | Overall Quality of Vision - 4-Month Questionnaire | Missing Response (Subject didn't answer the item) | 7 Responses |
| Control | Overall Quality of Vision - 4-Month Questionnaire | Neither Agree Nor Disagree | 2 Responses |
Secondary
Pulfrich Effect
Pulfrich effect was assessed subjectively using the item While wearing these lenses, my depth perception of moving objects has NOT been impacted. Subjects who disagreed or strongly disagreed with the statement were considered to have experienced the Pulfrich effect. In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for this secondary endpoint data summary.
Time frame: 2-week, 4-month, and 12-month questionnaire follow-up
Population: All subjects in the full analysis population excluding subjects that should have been deemed ineligible due to the new prescription of multifocal, toric, or daily disposable contact lenses at the screening visit. There were 58 subjects in Full Analysis population, but 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for the secondary endpoint data summary.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Test | Pulfrich Effect | Number of Subjects Experienced the Pulfrich Effect at Least Once | 4 Number of responses |
| Test | Pulfrich Effect | Number of Subjects Experienced the Pulfrich Effect at 2-Week Evaluation | 4 Number of responses |
| Test | Pulfrich Effect | Number of Subjects Experienced the Pulfrich Effect at 4-Month Evaluation | 0 Number of responses |
| Test | Pulfrich Effect | Number of Subjects Experienced the Pulfrich Effect at 12-Month Evaluation | 0 Number of responses |
| Control | Pulfrich Effect | Number of Subjects Experienced the Pulfrich Effect at 12-Month Evaluation | 0 Number of responses |
| Control | Pulfrich Effect | Number of Subjects Experienced the Pulfrich Effect at Least Once | 1 Number of responses |
| Control | Pulfrich Effect | Number of Subjects Experienced the Pulfrich Effect at 4-Month Evaluation | 1 Number of responses |
| Control | Pulfrich Effect | Number of Subjects Experienced the Pulfrich Effect at 2-Week Evaluation | 0 Number of responses |
Secondary
Serious or Significant Adverse Events
A serious adverse event is any untoward medical occurrence that is potentially sight-threatening, requires hospitalization, results in persistent or significant disability / incapacity, or requires intervention to prevent permanent damage. Significant adverse events are usually symptomatic and warrant discontinuation (temporary or permanent) of the test article (excluding serious adverse events).
Time frame: Throughout the duration of the study, up to 12 months
Population: The full analysis set including all enrolled subjects (signed consent form) regardless of subsequent withdrawal from study or deviation from protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Test | Serious or Significant Adverse Events | 0 Number of adverse events |
| Control | Serious or Significant Adverse Events | 0 Number of adverse events |