Visual Performance
Conditions
Brief summary
The objective of this study is to assess how various silicone hydrogel lenses perform when worn by subjects who are heavy digital device users.
Interventions
DEVICEMarketed Soft Contact lens
Replacement schedule every 2 weeks
DEVICEAIR OPTIX® AQUA
Replacement schedule every 4 weeks
DEVICEBiofinity®
Replacement schedule every 4 weeks
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject must read, understand and sign the statement of Informed Consent and receive a fully executed copy of the form. 2. The subject must be between 18 and 40 years of age. 3. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50D to -8.00D in each eye. 4. The subject's refractive cylinder must be no more than -1.25 D cylindrical correction in each eye after vertexing to the corneal plane. 5. The subject must have best corrected visual acuity of 0.20 or better in each eye. 6. The subject must be a current wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/ week and at least 8 hours/day during the month prior to enrollment. 7. The subject must be using digital devices (any combination of computers, tablets, smartphones, etc.) for at least 8 hours over the course of a typical day. 8. The subject should own a wearable pair of spectacles and wear them the day of the baseline visit. 9. The subject must have normal eyes with no evidence of abnormality or disease that in the opinion of the investigator would contraindicate contact lens wear. 10. The subject must meet normal eligibility conditions of binocular vision tests. 11. The subject may not have any double vision at near with their habitual contact lens correction.
Exclusion criteria
1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). 2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear (at the investigator's discretion). 3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion). 4. Use of any medication that causes side effects similar to side effects experienced when using digital devices, such as subjects reporting headaches associated with birth control pills (at the investigator's discretion). 5. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease. 6. Any active ocular infection. 7. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry. 8. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.). 9. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. 10. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. 11. Any known hypersensitivity or allergic reaction to the study products. 12. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment. 13. History of binocular abnormality or strabismus. 14. Employee of investigational clinic (e.g. Investigator, Coordinator, Technician).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Overall Comfort | 1-Day Follow-up | Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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. Scores range 0-120. |
| Subjective Overall Quality of Vision | 1-Day Follow-up | Subjective Overall quality of vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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. Scores range 0-120. |
Countries
Canada
Participant flow
Pre-assignment details
A total of 52 subjects were enrolled in this study. Of the enrolled subjects 10 subjects did not meet the eligibility criteria and 42 subjects were dispensed study lenses. Of the dispensed subjects 37 completed the study while 5 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Dispensed Subjects All subjects that were dispensed at least 1 study lens. | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Period 1 | Lens Discomfort | 0 | 0 | 0 | 0 | 0 | 1 |
| Period 1 | Withdrawal by Subject | 0 | 1 | 1 | 1 | 0 | 0 |
| Period 2 | Unsatisfactory Visual Response | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Dispensed Subjects |
|---|---|
| Age, Continuous | 24.0 years STANDARD_DEVIATION 4.74 |
| Race/Ethnicity, Customized Asian | 20 participants |
| Race/Ethnicity, Customized Black or African American | 1 participants |
| Race/Ethnicity, Customized White | 21 participants |
| Region of Enrollment Canada | 42 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 42 | 0 / 42 | 2 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 | 0 / 42 |
Outcome results
Primary
Subjective Overall Comfort
Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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. Scores range 0-120.
Time frame: 1-Day Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Subjective Overall Comfort | 65.0 units on a scale | Standard Deviation 19.76 |
| Lotrafilcon B | Subjective Overall Comfort | 53.6 units on a scale | Standard Deviation 23.34 |
| Comfilcon A | Subjective Overall Comfort | 61.9 units on a scale | Standard Deviation 22.7 |
Primary
Subjective Overall Quality of Vision
Subjective Overall quality of vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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. Scores range 0-120.
Time frame: 1-Day Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Subjective Overall Quality of Vision | 63.6 units on a scale | Standard Deviation 17.76 |
| Lotrafilcon B | Subjective Overall Quality of Vision | 63.8 units on a scale | Standard Deviation 18.24 |
| Comfilcon A | Subjective Overall Quality of Vision | 65.8 units on a scale | Standard Deviation 18.39 |