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This is a bilateral, dispensing, randomized, controlled, subject-masked, 2-arm parallel study to evaluate safety and efficacy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEST lens | Experimental | 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. |
|
| CONTROL lens | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A C3 | Device | TEST Lens |
| |
| senofilcon A |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Be between 18 and 39 (inclusive) years of age at the time of screening.
By self-report, habitually wear spherical silicone hydrogel soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.
Have a habitual contact lens prescription that is current within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.
The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 D in both eyes.
The subject's refractive cylinder must be 1.00 D or less.
The subject must have best corrected visual acuity of 20/25 or better in each eye.
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
11. Have any ocular infection. 12. Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
13. Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Vision Care, Inc. Clinical Trial | Johnson & Johnson Vision Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James T. Fujimoto, O.D. | Cupertino | California | 95014 | United States | ||
| Randall Go, OD |
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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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control (Senofilcon A) | Subjects that wore the Control (senofilcon A) lens during the study. |
| FG001 | Test (Senofilcon A C3) | Subjects that wore the Test lens during the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2021 |
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| Device |
CONTROL Lens |
|
| Up to 2-Week Follow-up |
| 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. | 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. | 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. | 2-Week Follow-up |
| San Francisco |
| California |
| 94110 |
| United States |
| Dr. James Weber & Associates, PA | Jacksonville | Florida | 32205 | United States |
| Sabal Eye Care | Longwood | Florida | 32779 | United States |
| Flora Chen Poveda, OD, PA | Orange Park | Florida | 32073 | United States |
| Tallahassee Eye Center | Tallahassee | Florida | 32308 | United States |
| VisualEyes, Inc | Roswell | Georgia | 30076 | United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| Birmingham Vision Care | Bloomfield Township | Michigan | 48301 | United States |
| Dr. Debbie H. Kim, OD | Closter | New Jersey | 07624 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Professional Vision Care, Inc. | Westerville | Ohio | 43081 | United States |
| West Bay Eye Associates | Warwick | Rhode Island | 02888 | United States |
| Primary Eyecare Group | Brentwood | Tennessee | 37027 | United States |
| Tyler Eye Associates | Tyler | Texas | 75703 | United States |
| William J. Bogus, OD, FAAO | Salt Lake City | Utah | 84106 | United States |
| Botetourt Eyecare, LLC | Salem | Virginia | 24153 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control (Senofilcon A) | Subjects that wore the Control (senofilcon A) lens during the study. |
| BG001 | Test (Senofilcon A C3) | Subjects that wore the Test lens during the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | 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 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. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Units on a scale | 2-Week Follow-up |
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| Primary | 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. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | logMAR | 2-Week Follow-up | eyes | eyes |
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| Primary | 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. | All subjects were dispensed at least one study lens. Subjects were summarized by actual treatment received. | Posted | Number | proportion of eyes | up to 2-week follow-up | eyes | eyes |
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| Primary | 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. | All subjects were dispensed at least one study lens. Subjects were summarized by actual treatment received. | Posted | Number | proportion of eyes | Up to 2-Week Follow-up | eyes | eyes |
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| Secondary | 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. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Units on a scale | 2-Week Follow-up |
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| Secondary | 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. | All subjects that completed all study visits without a major protocol deviation. | Posted | Mean | Standard Deviation | Units on a scale | 2-Week Follow-up |
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| Secondary | 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. | All subjects that completed all study visits without a major protocol deviation. | Posted | Number | number of responses | 2-Week Follow-up |
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| Secondary | 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. | All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol. | Posted | Number | number of responses | 2-Week Follow-up |
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Throughout the duration of the study; The study duration for each subject was approximately 2 weeks.
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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 | Control (Senofilcon A) | Subjects that wore the Control (senofilcon A) lens during the study. | 0 | 150 | 0 | 150 | 0 | 150 |
| EG001 | Test (Senofilcon A C3) | Subjects that wore the Test (senofilcon A C3) lens during the study. | 0 | 145 | 0 | 145 | 0 | 145 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John R. Buch-Sr. Principal Research Optometrist | Johnson & Johnson Vision Care, Inc. | 1-800-843-2020 | jbuch@its.jnj.com |
| Nov 16, 2022 |
| Prot_SAP_000.pdf |
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| Male |
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| Asian |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Multiple |
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| Non-Inferiority |
Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval of the mean difference was above -5. |
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