An interventional study of TEST Contact Lens and CONTROL Contact Lens in Visual Acuity, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 13 sites in United States. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-18.
Sponsored by Johnson & Johnson Vision Care, Inc. · Not applicable, Interventional, and Treatment
Adaptive, randomized, subject-masked, dispensing study to evaluate the short-term, clinical performance of two FDA-approved contact lens.
Johnson & Johnson Vision Care, Inc. is the lead sponsor of 220 studies on the registry; 2 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 101 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: TEST Contact Lens · Device: CONTROL Contact Lens
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.
Device: TEST Contact Lens · Device: CONTROL Contact Lens
Also known as: senofilcon A
Also known as: stenfilcon A
Overall Comfort
Overall comfort was assessed using the Contact Lens User Experience™ (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.
Time frame: 7-Day Follow-up
Overall Quality of Vision
Overall quality of vision was assessed using the Contact Lens User Experience™ (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.
Time frame: 7-Day Follow-up
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"
Time frame: 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"
Time frame: 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"
Time frame: 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".
Time frame: 7-Day Follow-up
| Milestone | Senofilcon A/ Stenfilcon A/ Senofilcon A | Stenfilcon A/ Senofilcon A/ Stenfilcon A |
|---|---|---|
| Started | 141 | 142 |
| Completed | 138 | 140 |
| Not completed | 3 | 2 |
| Withdrew: Test article no longer available | 1 | 1 |
| Withdrew: No longer meets eligibility criteria. | 1 | 0 |
| Withdrew: Miss-randomized | 1 | 1 |
| Milestone | Senofilcon A/ Stenfilcon A/ Senofilcon A | Stenfilcon A/ Senofilcon A/ Stenfilcon A |
|---|---|---|
| Started | 138 | 140 |
| Completed | 137 | 139 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Test article no longer available | 0 | 1 |
| Milestone | Senofilcon A/ Stenfilcon A/ Senofilcon A | Stenfilcon A/ Senofilcon A/ Stenfilcon A |
|---|---|---|
| Started | 137 | 139 |
| Completed | 137 | 139 |
| Not completed | 0 | 0 |
Overall comfort was assessed using the Contact Lens User Experience™ (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.
| Units on a Scale | Senofilcon A | Stenfilcon A |
|---|---|---|
| Overall Comfort | 72.5 ± 27.9 | 63.8 ± 30.1 |
Overall quality of vision was assessed using the Contact Lens User Experience™ (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.
| Units on a Scale | Senofilcon A | Stenfilcon A |
|---|---|---|
| Overall Quality of Vision | 67.5 ± 20.6 | 62.1 ± 22.3 |
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"
| Percentage of Responses | Senofilcon A | Stenfilcon A |
|---|---|---|
| [Lenses were very comfortable at end of day] | 75.1 | 65.1 |
| [Comfort of lenses decreased during day] | 68.5 | 58.1 |
| [Comfortable lenses when i got up to bed time] | 75 | 61.1 |
| Overall Comfort | 79.5 | 67.5 |
| Comfort Throughout the Day | 72.3 | 58.2 |
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"
| Percentage of Responses | Senofilcon A | Stenfilcon A |
|---|---|---|
| [Remained Comfortable from Insertion to Removal] | 79.3 | 69.8 |
| Comfort Activity to Activity | 81.6 | 69.8 |
| Comfort Across Different Environments | 78.3 | 66.9 |
| [Comfort Working on a computer] | 79.3 | 70.3 |
| [Satisfied with Distance Visions at Insertion] | 91.3 | 90.2 |
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"
| Percentage of Responses | Senofilcon A | Stenfilcon A |
|---|---|---|
| [Satisfied with Distance Vision] | 91.3 | 90.2 |
| [Satisfied with Clarity of Vision at end of day] | 85.8 | 77.3 |
| [Satisfied with my Quality of Vision at Night] | 89.9 | 84.2 |
| [Confidence to Drive at Night with these lenses] | 91.3 | 86.9 |
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".
| Percentage of Responses | Senofilcon A | Stenfilcon A |
|---|---|---|
| Clarity of Vision During Daily Activities | 85.6 | 74.5 |
| [Clarity of Vision in Dim or Low Lighting] | 83.3 | 73.8 |
| Clarity of Vision When Driving at Night | 81.5 | 70.8 |
Collected over Throughout the entire duration of the study. Approximately 30 days per subject.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Senofilcon A | — | 0/141 (0%) | 0/141 (0%) |
| Stenfilcon A | — | 1/142 (0.7%) | 0/142 (0%) |
| Event | Senofilcon A | Stenfilcon A |
|---|---|---|
| HospitalizationGeneral disorders | 0/141 | 1/142 |
| Age, Continuous(Years) | Dispensed Subjects |
|---|---|
| Mean | 28.0 ± 5.75 |
| Sex: Female, Male(Participants) | Dispensed Subjects |
|---|---|
| Female | 184 |
| Male | 92 |
| Race/Ethnicity, Customized(Participants) | Dispensed Subjects |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 8 |
| Black or African American | 30 |
| White | 237 |
| Region of Enrollment(Participants) | Dispensed Subjects |
|---|---|
| United States | 276 |
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Vision Care, Inc.