A Phase 2/3 interventional study of senofilcon A TEST Lens and senofilcon A CONTROL Lens in Correction of Refraction Error and Attenuation of Bright Light, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 5 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-04.
Sponsored by Johnson & Johnson Vision Care, Inc. · Phase 2/3, Interventional, and Treatment
This study is a randomized, 4-visit, double-masked, 2x3 bilateral crossover, dispensing trial. The study lenses will be worn as daily wear (DW) for a period of two weeks each with one of the study lenses being worn twice. Each study lens is expected to be worn at least five (5) days per week for at least six (6) hours per day worn. There will be no washout period between study lenses.
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:
Subjects that are of 18 years or older and current spherical soft contact lens wearers will wear the Test and Control lenses for two weeks each in random order with one of the study lenses being worn twice for a total of 6 weeks per subject.
Device: senofilcon A TEST Lens · Device: senofilcon A CONTROL Lens
Subjects that are of 18 years or older and current spherical soft contact lens wearers will wear the Test and Control lenses for two weeks each in random order with one of the study lenses being worn twice for a total of 6 weeks per subject.
Device: senofilcon A TEST Lens · Device: senofilcon A CONTROL Lens
senofilcon A with new UV blocker investigational process
senofilcon A with new UV blocker standard process
Overall Comfort Score
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. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported.
Time frame: 2- Week Follow-up Evaluation
Overall Vision Score
Overall 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. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported.
Time frame: 2- Week Follow-up Evaluation
A total of 92 subjects were enrolled into this study. Of those enrolled, 91 were dispensed a study lens and 1 subject failed to meet the eligibility criteria. Of the dispensed subjects 83 completed the study while 8 subjects were discontinued.
| Milestone | Test/Control/Control | Control/Test/Test |
|---|---|---|
| Started | 46 | 45 |
| Completed | 43 | 44 |
| Not completed | 3 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Adverse event | 2 | 1 |
| Milestone | Test/Control/Control | Control/Test/Test |
|---|---|---|
| Started | 43 | 44 |
| Completed | 40 | 43 |
| Not completed | 3 | 1 |
| Withdrew: Adverse event | 3 | 0 |
| Withdrew: Protocol violation | 0 | 1 |
| Milestone | Test/Control/Control | Control/Test/Test |
|---|---|---|
| Started | 40 | 43 |
| Completed | 40 | 43 |
| 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. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported.
| Units on a scale | Test | Control |
|---|---|---|
| Overall Comfort Score | 61.49 ± 21.087 | 67.27 ± 22.865 |
Overall 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. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported.
| Units on a scale | Test | Control |
|---|---|---|
| Overall Vision Score | 61.79 ± 17.758 | 64.92 ± 17.444 |
Collected over Throughout the entire duration of the study. Approximately 6 weeks per subject.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test | 0/91 (0%) | 0/91 (0%) | 0/91 (0%) |
| Control | 0/91 (0%) | 0/91 (0%) | 0/91 (0%) |
| Age, Continuous(Years) | Dispensed Subjects |
|---|---|
| Mean | 31.8 ± 6.32 |
| Sex: Female, Male(Participants) | Dispensed Subjects |
|---|---|
| Female | 61 |
| Male | 30 |
| Race/Ethnicity, Customized(Participants) | Dispensed Subjects |
|---|---|
| American Indian or Native Alaska | 0 |
| Asian | 11 |
| Black or African American | 3 |
| Native Hawaiian or Other Pacific Islander | 1 |
| White | 69 |
| Other | 7 |
| Region of Enrollment(Participants) | Dispensed Subjects |
|---|---|
| United States | 91 |
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Johnson & Johnson Vision Care, Inc.