An interventional study of senofilcon A C3 and senofilcon A in Visual Acuity, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 17 sites in United States. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-06.
Sponsored by Johnson & Johnson Vision Care, Inc. · Not applicable, Interventional, and Treatment
This is a bilateral, dispensing, randomized, controlled, subject-masked, 2-arm parallel study to evaluate safety and efficacy
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.
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Eligible subjects that are habitual wearers of silicone hydrogel spherical contact lenses will be randomized to the TEST Lens for the duration of the study.
Device: senofilcon A C3
Eligible subjects that are habitual wearers of silicone hydrogel spherical contact lenses will be randomized to the CONTROL Lens for the duration of the study.
Device: senofilcon A
TEST Lens
CONTROL Lens
Overall Quality of Vision Score
Overall quality of vision score 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. The average CLUE vision score for each lens type was reported.
Time frame: 2-Week Follow-up
Distance Monocular logMAR Visual Acuity
Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale and was evaluated at distance (4 meter) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Time frame: 2-Week Follow-up
Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits, 2-week follow-up and final evaluation). The data was then dichotomized into two groups. Those with Grade 3 or higher SLF and those with Grade 2 or lower. The proportion of eyes with Grade 3 or higher SLF was reported.
Time frame: up to 2-week follow-up
Proportion of Eyes With Unacceptable Lens Fitting
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported. Summaries presented in the Participant flow are summarized by planned arm, where as summaries for this measure are summarized by actual arm. One subject was dispensed the incorrect study lens, there for, the number of subjects that were randomized to the Control were 149 but 150 subjects were actually dispensed the control.
Time frame: Up to 2-Week Follow-up
Overall Comfort Scores
Overall comfort scores were 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. The average CLUE comfort score for each lens type was reported.
Time frame: 2-Week Follow-up
Overall Handling Scores
Overall handling scores were 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. The average CLUE handling score for each lens type was reported.
Time frame: 2-Week Follow-up
Situational Visual Performance - Indoors
Indoor performance was assessed using the individual questionnaire item "Clarity of Vision indoors in bright light" with a 5-point Likert scale (1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor) and a Not Applicable response option. Subject responses were reported by lens using frequencies.
Time frame: 2-Week Follow-up
Situational Visual Performance - Digital Devices
Situational visual performance related to digital device use was assessed using the individual preference item "Overall preference while using computer screens \& digital devices". The response set include: Strongly prefer my habitual lenses, Slightly prefer my habitual lenses, No Preference, Slightly prefer the study lenses and Strongly prefer the study lenses. Responses were collapsed into three categories for analysis purpose: Prefer Study Lens, No Preference, Prefer Habitual Lens. Subject responses were reported by lens using frequencies.
Time frame: 2-Week Follow-up
A total of 296 subjects were enrolled in this study. Of those enrolled, 295 subjects were dispensed at least one study lens, while 1 subject failed to meet all eligibility criteria. Of those dispensed, 289 subjects completed the study while 6 subjects were discontinued.
| Milestone | Control (Senofilcon A) | Test (Senofilcon A C3) |
|---|---|---|
| Started | 150 | 145 |
| Completed | 145 | 144 |
| Not completed | 5 | 1 |
| Withdrew: Subject enrolled in error | 1 | 0 |
| Withdrew: Study procedure | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Subject no longer meets eligibility criteria | 1 | 0 |
Overall quality of vision score 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. The average CLUE vision score for each lens type was reported.
| Units on a scale | Control (Senofilcon A) | Test (Senofilcon A C3) |
|---|---|---|
| Overall Quality of Vision Score | 67.0 ± 20.02 | 70.4 ± 19.73 |
Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale and was evaluated at distance (4 meter) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
| logMAR | Control (Senofilcon A) | Test (Senofilcon A C3) |
|---|---|---|
| Distance Monocular logMAR Visual Acuity | -0.12 ± 0.093 | -0.11 ± 0.080 |
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits, 2-week follow-up and final evaluation). The data was then dichotomized into two groups. Those with Grade 3 or higher SLF and those with Grade 2 or lower. The proportion of eyes with Grade 3 or higher SLF was reported.
| proportion of eyes | Control (Senofilcon A) | Test (Senofilcon A C3) |
|---|---|---|
| Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings | 0 | 0 |
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported. Summaries presented in the Participant flow are summarized by planned arm, where as summaries for this measure are summarized by actual arm. One subject was dispensed the incorrect study lens, there for, the number of subjects that were randomized to the Control were 149 but 150 subjects were actually dispensed the control.
| proportion of eyes | Control (Senofilcon A) | Test (Senofilcon A C3) |
|---|---|---|
| Proportion of Eyes With Unacceptable Lens Fitting | 0 | 0 |
Overall comfort scores were 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. The average CLUE comfort score for each lens type was reported.
| Units on a scale | Control (Senofilcon A) | Test (Senofilcon A C3) |
|---|---|---|
| Overall Comfort Scores | 70.5 ± 22.83 | 70.4 ± 22.66 |
Overall handling scores were 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. The average CLUE handling score for each lens type was reported.
| Units on a scale | Control (Senofilcon A) | Test (Senofilcon A C3) |
|---|---|---|
| Overall Handling Scores | 69.2 ± 20.13 | 67.8 ± 20.44 |
Indoor performance was assessed using the individual questionnaire item "Clarity of Vision indoors in bright light" with a 5-point Likert scale (1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor) and a Not Applicable response option. Subject responses were reported by lens using frequencies.
| number of responses | Control (Senofilcon A) | Test (Senofilcon A C3) |
|---|---|---|
| Not Applicable | 0 | 0 |
| Excellent | 75 | 85 |
| Very Good | 51 | 48 |
| Good | 17 | 11 |
| Fair | 1 | 0 |
| Poor | 1 | 0 |
Situational visual performance related to digital device use was assessed using the individual preference item "Overall preference while using computer screens \& digital devices". The response set include: Strongly prefer my habitual lenses, Slightly prefer my habitual lenses, No Preference, Slightly prefer the study lenses and Strongly prefer the study lenses. Responses were collapsed into three categories for analysis purpose: Prefer Study Lens, No Preference, Prefer Habitual Lens. Subject responses were reported by lens using frequencies.
| number of responses | Control (Senofilcon A) | Test (Senofilcon A C3) |
|---|---|---|
| Strongly prefer my habitual lenses | 17 | 12 |
| Slightly prefer my habitual lenses | 16 | 16 |
| No Preference | 61 | 48 |
| Slightly prefer the study lenses | 36 | 42 |
| Strongly prefer the study lenses | 16 | 26 |
Collected over Throughout the duration of the study; The study duration for each subject was approximately 2 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control (Senofilcon A) | 0/150 (0%) | 0/150 (0%) | 0/150 (0%) |
| Test (Senofilcon A C3) | 0/145 (0%) | 0/145 (0%) | 0/145 (0%) |
| Age, Continuous(years) | Control (Senofilcon A) | Test (Senofilcon A C3) | Total |
|---|---|---|---|
| Age | 30.0 ± 5.86 | 29.0 ± 5.70 | 29.5 ± 5.80 |
| Sex: Female, Male(Participants) | Control (Senofilcon A) | Test (Senofilcon A C3) | Total |
|---|---|---|---|
| Gender — Female | 102 | 100 | 202 |
| Gender — Male | 48 | 45 | 93 |
| Race/Ethnicity, Customized(Participants) | Control (Senofilcon A) | Test (Senofilcon A C3) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 10 | 12 | 22 |
| Black or African American | 7 | 8 | 15 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| White | 131 | 122 | 253 |
| Multiple | 1 | 3 | 4 |
| Region of Enrollment(Participants) | Control (Senofilcon A) | Test (Senofilcon A C3) | Total |
|---|---|---|---|
| United States | 150 | 145 | 295 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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Johnson & Johnson Vision Care, Inc.