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Adaptive, randomized, subject-masked, dispensing study to evaluate the short-term, clinical performance of two FDA-approved contact lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Test/Control/Test) | Active Comparator | Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the TEST / CONTROL / TEST wearing sequence will wear lenses as daily disposable on both eyes for approximately one week each with no washout period between lenses for at least five days, and 8 hours per day. |
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| Group 2 (Control/Test/Control) | Active Comparator | Subjects randomly assigned to the TEST Contact Lens or the CONTROL Contact Lens in the CONTROL / TEST / CONTROL wearing sequence will wear lenses as daily disposable on both eyes for approximately one week each with no washout period between lenses for at least five days, and 8 hours per day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEST Contact Lens | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort | Overall comfort was assessed using the Contact Lens User Experienceâ„¢ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively. | 7-Day Follow-up |
| Overall Quality of Vision | Overall quality of vision was assessed using the Contact Lens User Experienceâ„¢ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively. | 7-Day Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Individual Patient Reported Outcomes (Items 1-5) | Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space)1."These Lenses Were Very Comfortable At The End Of The Day" 2."The Comfort of these lenses decreased throughout the day" 3. The lenses were very comfortable from the time I got up to the time I went to bed" 4. "Overall Comfort" 5. "Comfort throughout the Day" |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Becky Bizzle, OD | Montgomery | Alabama | 36117 | United States | ||
| Complete Family Eye Care of Fruit Cove |
A total of 283 subjects were enrolled into this study. Of the enrolled subjects all were dispensed at least one study lens. Of the dispensed subjects 276 subjects completed the study and 7 subjects were discontinued.
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A/ Stenfilcon A/ Senofilcon A | Subjects randomized to this sequence received the senofilcon A lens during the first period, the stenfilcon A lens during the second period and the senofilcon A lens during the third period. |
| FG001 | Stenfilcon A/ Senofilcon A/ Stenfilcon A |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
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| CONTROL Contact Lens | Device |
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| 7-Day Follow-up |
| Individual Patient Reported Outcomes (Items 6-10) | Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space)6. "Comfort at the end of the day" 7. They remained comfortable from the moment I put them in until the moment I took them out" 8."Comfort from activity to activity" 9. Comfort across different environments" 10."Comfort while working on a computer" | 7-Day Follow-up |
| Individual Patient Reported Outcomes (Items 11-14) | Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space). 11."I was very satisfied with my distance vision when i first put these lenses in my eyes. 12."I was very satisfied by the clarity of my vision at the end of the day" 13."I was satisfied with the quality of my vision at night" 14."With these lenses, I felt very confident to drive at night" | 7-Day Follow-up |
| Individual Patient Reported Outcomes (Items 15-17) | Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space). 15."Clarity of vision during daily activities" 16."Clarity of vision in dim or low lighting conditions" 17. "Clarity of visions when driving at night". | 7-Day Follow-up |
| Jacksonville |
| Florida |
| 32259 |
| United States |
| Golden Family Eyecare | Sarasota | Florida | 34232 | United States |
| St. Lucy's Vision Center | Tampa | Florida | 33625 | United States |
| Eye Associates of Winter Park | Winter Park | Florida | 32792 | United States |
| VisualEyes, Inc. | Roswell | Georgia | 30076 | United States |
| Advantage Eyecare Associates, LLC | Neodesha | Kansas | 66757 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Advanced Family Eye Care | Denver | North Carolina | 28037 | United States |
| Total Eye Care PA | Memphis | Tennessee | 38119 | United States |
| Brian Frazier, OD | Jacksonville | Texas | 17576 | United States |
| Timothy R. Poling, OD | Salem | Virginia | 24153 | United States |
| Ziegler Leffingwell Eyecare | West Allis | Wisconsin | 53227 | United States |
subjects randomized to this sequence received the stenfilcon A lens during the first period, the senofilcon A lens during the second period and the stenfilcon A lens during the third period. |
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| NOT COMPLETED |
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| Period 2 |
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| Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dispensed Subjects | All subjects that were dispensed at least one study lens. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Region of Enrollment | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Comfort | Overall comfort was assessed using the Contact Lens User Experienceâ„¢ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Units on a Scale | 7-Day Follow-up | Observations | Observations |
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| Primary | Overall Quality of Vision | Overall quality of vision was assessed using the Contact Lens User Experienceâ„¢ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively. | Subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Units on a Scale | 7-Day Follow-up | Observations | Observations |
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| Secondary | Individual Patient Reported Outcomes (Items 1-5) | Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space)1."These Lenses Were Very Comfortable At The End Of The Day" 2."The Comfort of these lenses decreased throughout the day" 3. The lenses were very comfortable from the time I got up to the time I went to bed" 4. "Overall Comfort" 5. "Comfort throughout the Day" | Subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of Responses | 7-Day Follow-up | Observations | Observations |
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| Secondary | Individual Patient Reported Outcomes (Items 6-10) | Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space)6. "Comfort at the end of the day" 7. They remained comfortable from the moment I put them in until the moment I took them out" 8."Comfort from activity to activity" 9. Comfort across different environments" 10."Comfort while working on a computer" | Subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of Responses | 7-Day Follow-up | Observations | Observations |
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| Secondary | Individual Patient Reported Outcomes (Items 11-14) | Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space). 11."I was very satisfied with my distance vision when i first put these lenses in my eyes. 12."I was very satisfied by the clarity of my vision at the end of the day" 13."I was satisfied with the quality of my vision at night" 14."With these lenses, I felt very confident to drive at night" | Subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of Responses | 7-Day Follow-up | Observations | Observations |
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| Secondary | Individual Patient Reported Outcomes (Items 15-17) | Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space). 15."Clarity of vision during daily activities" 16."Clarity of vision in dim or low lighting conditions" 17. "Clarity of visions when driving at night". | Subjects that completed all study visits without a major protocol deviation. | Posted | Number | Percentage of Responses | 7-Day Follow-up | Observations | Observations |
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Throughout the entire duration of the study. Approximately 30 days per subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Senofilcon A | Subjects that received the senofilcon A lens during any of the three study periods. | 0 | 141 | 0 | 141 | ||
| EG001 | Stenfilcon A | Subjects that received the stenfilcon A lens during any three of the study periods. | 1 | 142 | 0 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Hospitalization | General disorders | Subjects was hospitalized for an unknown reason, this event was not related to the study lens. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Pall, OD, MS, FAAO | Johnson & Johnson Vision Care Inc. | 904 443-1290 | BPALL@its.jnj.com |
| Black or African American |
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| White |
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