Visual Acuity
Conditions
Brief summary
This is a multi-site, randomized, bilateral, dispensing, parallel design study with two arms to evaluate contact lens related dry eye symptoms and subjective comfort.
Interventions
DEVICEACUVUE Oasys 1-Day
TEST
DEVICEHabitual Lens
Subjects' own Habitual Lenses
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
\- Potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. Between 18 and 59 (inclusive) years of age at the time of screening. 4. Be a daily disposable current soft contact lens wearer in both eyes with a minimum of 6 days/week wear time over the last 1 month by self-report. 5. Have a CLDEQ-8 score of 15 or greater with the habitual lens. 6. Subjects must possess a pair of spectacles for distance correction. 7. Subject's habitual lens must be the following lens types: Alcon DAILIES® Aqua Comfort Plus® , Alcon DAILIES TOTAL1®, CooperVision® clariti® 1 day, CooperVision® MyDay®, or Johnson & Johnson 1-Day ACUVUE® Moist. 8. The subject's vertex corrected spherical distance refraction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye. 9. The magnitude of subject's vertex corrected refractive cylinder must be less than 1.00 diopter in each eye. 11\. Have spherical 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: 1. Subject's habitual lens is ACUVUE OASYS®1-Day. 2. Currently pregnant or lactating, by self-report. 3. Any ocular or systemic allergies, disease or use of medication which may interfere with contact lens wear (at the discretion of the investigator). 4. Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator). 5. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report. 6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 7. Habitual contact lens wear modality as extended wear (≥1 night per month of extended wear). 8. Habitual contact lens is rigid gas permeable, toric, monovision or multi-focal. 9. . Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.). 10. Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment. 11. Employee or employee's immediate family member of clinical site (e.g., Investigator, Coordinator, Technician). 12. Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (Rx or over the counter (OTC)) that may interfere with contact lens wear (at the discretion of the investigator). 13. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion. 14. Any Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA classification scale.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Comfort Score | Up to 2-Week Follow-up | 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. The change from baseline was calculated as 2-week follow-up minus baseline. The average change from baseline was reported for each arm. the change from baseline ranges from -120 to 120 where higher change from baseline comfort scores indicates a more favorable performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline CLDEQ-8 Score | Up to 2-Week Follow-up | The CLDEQ-8 is a validated outcome measure for soft contact lenses wearers. It has been highly correlated with habitual baseline status and change in overall opinion when subjects are refit with contact lenses. A CLDEQ-8 total score of ≥12 is proposed to identify contact lens wearers who could benefit from clinical management of their contact lens related symptoms. A three-point change in CLDEQ-8 total scores has also been shown to be clinically important. This study will include the symptomatic subjects who will have a CLDEQ total score of ≥15. CLDEQ-8 scores range from 0 to 30 where, higher CLDEQ-8 score indicates more dry eye symptoms with respect to contact lens wear. The change is calculated as 2-week minus Baseline. The change from baseline CLDEQ-8 score ranges from -30 to 30 where lower change from baseline CLDEQ-8 scores indicate better performance. The average change in CLDEQ-8 for each arm was reported. |
| Comfort Score | 2-Week Follow-up | 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. The average comfort score was reported for each group within Arm 2 only. |
| CLDEQ-8 Score | 2-Week Follow-up | The CLDEQ-8 is a validated outcome measure for soft contact lenses wearers. It has been highly correlated with habitual baseline status and change in overall opinion when subjects are refit with contact lenses. A CLDEQ-8 total score of ≥12 is proposed to identify contact lens wearers who could benefit from clinical management of their contact lens related symptoms. A three-point change in CLDEQ-8 total scores has also been shown to be clinically important. This study will include the symptomatic subjects who will have a CLDEQ total score of ≥15. CLDEQ-8 scores range from 0 to 30 where, higher CLDEQ-8 score indicates more dry eye symptoms with respect to contact lens wear. The average CLDEQ-8 for each arm was reported. |
Countries
United States
Participant flow
Recruitment details
A total of 95 subjects were enrolled in this study. Of those enrolled, 47 were randomized to Arm1 and dispensed at least one study lens, while 45 subjects were randomized to Arm 2 and were dispensed at least 1 study lenses. All dispensed subjects in Arm 1 completed the study while only 39 of those dispensed in Arm 2 completed the study. A total of 6 subjects were discontinued from Arm 2.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Subjects randomized to this Arm were dispensed the senofilcon A for approximately 2 weeks, then returned for follow-up evaluation and were exited from the study. | 47 |
| Arm 2 Subjects randomized to this Arm were dispensed their habitual lenses A for approximately 2 weeks, then returned for follow-up evaluation. Subjects were then dispensed senofilcon A for approximately 2 weeks, then returned for follow-up evaluation and were exited from the study. | 45 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Covid-19 Related | 1 | 0 |
| Period 1 | Subject no longer meet eligibility criteria | 3 | 0 |
| Period 2 | Subject no longer meet eligibility criteria | 2 | 0 |
Baseline characteristics
| Characteristic | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Age, Continuous | 34.6 years STANDARD_DEVIATION 8.14 | 34.0 years STANDARD_DEVIATION 8.42 | 34.3 years STANDARD_DEVIATION 8.23 |
| Race/Ethnicity, Customized Asian | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Other | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 45 participants | 45 participants | 90 participants |
| Region of Enrollment United States | 47 participants | 45 participants | 92 participants |
| Sex: Female, Male Female | 31 Participants | 34 Participants | 65 Participants |
| Sex: Female, Male Male | 16 Participants | 11 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 88 | 0 / 11 | 0 / 10 | 0 / 5 | 0 / 2 | 0 / 17 |
| other Total, other adverse events | 0 / 88 | 0 / 11 | 0 / 10 | 0 / 5 | 1 / 2 | 0 / 17 |
| serious Total, serious adverse events | 0 / 88 | 0 / 11 | 0 / 10 | 0 / 5 | 0 / 2 | 0 / 17 |
Outcome results
Primary
Change From Baseline Comfort Score
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. The change from baseline was calculated as 2-week follow-up minus baseline. The average change from baseline was reported for each arm. the change from baseline ranges from -120 to 120 where higher change from baseline comfort scores indicates a more favorable performance.
Time frame: Up to 2-Week Follow-up
Population: Subjects that completed all required study visits without a major protocol deviation impacting a primary or secondary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Change From Baseline Comfort Score | 28.99 Units on a scale | Standard Deviation 26.766 |
| Arm 2 (Subjects' Own Contact Lens) | Change From Baseline Comfort Score | -0.29 Units on a scale | Standard Deviation 10.245 |
95% CI: [24.602, 33.732]Bootstrapping methods
Secondary
Change From Baseline CLDEQ-8 Score
The CLDEQ-8 is a validated outcome measure for soft contact lenses wearers. It has been highly correlated with habitual baseline status and change in overall opinion when subjects are refit with contact lenses. A CLDEQ-8 total score of ≥12 is proposed to identify contact lens wearers who could benefit from clinical management of their contact lens related symptoms. A three-point change in CLDEQ-8 total scores has also been shown to be clinically important. This study will include the symptomatic subjects who will have a CLDEQ total score of ≥15. CLDEQ-8 scores range from 0 to 30 where, higher CLDEQ-8 score indicates more dry eye symptoms with respect to contact lens wear. The change is calculated as 2-week minus Baseline. The change from baseline CLDEQ-8 score ranges from -30 to 30 where lower change from baseline CLDEQ-8 scores indicate better performance. The average change in CLDEQ-8 for each arm was reported.
Time frame: Up to 2-Week Follow-up
Population: Subjects that completed all required study visits without a major protocol deviation impacting a primary or secondary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Change From Baseline CLDEQ-8 Score | -10.83 Unit on a scale | Standard Deviation 6.631 |
| Arm 2 (Subjects' Own Contact Lens) | Change From Baseline CLDEQ-8 Score | -1.23 Unit on a scale | Standard Deviation 3.638 |
95% CI: [-12.7, -8.6]Heterogeneous Mixed model analysis
Secondary
CLDEQ-8 Score
The CLDEQ-8 is a validated outcome measure for soft contact lenses wearers. It has been highly correlated with habitual baseline status and change in overall opinion when subjects are refit with contact lenses. A CLDEQ-8 total score of ≥12 is proposed to identify contact lens wearers who could benefit from clinical management of their contact lens related symptoms. A three-point change in CLDEQ-8 total scores has also been shown to be clinically important. This study will include the symptomatic subjects who will have a CLDEQ total score of ≥15. CLDEQ-8 scores range from 0 to 30 where, higher CLDEQ-8 score indicates more dry eye symptoms with respect to contact lens wear. The average CLDEQ-8 for each arm was reported.
Time frame: 2-Week Follow-up
Population: Subjects randomized to Arm 2 and completed all required study visits without a major protocol deviation impacting a primary or secondary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | CLDEQ-8 Score | 12.46 Unit on a scale | Standard Deviation 6.078 |
| Arm 2 (Subjects' Own Contact Lens) | CLDEQ-8 Score | 21.18 Unit on a scale | Standard Deviation 3.698 |
95% CI: [-10.1, -7]Heterogeneous mixed model analysis
Secondary
Comfort Score
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. The average comfort score was reported for each group within Arm 2 only.
Time frame: 2-Week Follow-up
Population: Subjects randomized to Arm 2 and completed all required study visits without a major protocol deviation impacting a primary or secondary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Comfort Score | 55.88 Unit on a scale | Standard Deviation 25.721 |
| Arm 2 (Subjects' Own Contact Lens) | Comfort Score | 29.69 Unit on a scale | Standard Deviation 13.849 |
95% CI: [19, 32.9]Heterogeneous Mixed model analysis