Visual Acuity
Conditions
Brief summary
This is a randomized, double-masked dispensing study where subjects will randomized into one of two lens sequences to wear each of two contact lens types for a 4-week period with each lens type.
Interventions
DEVICETEST Contact Lens
DEVICECONTROL Contact Lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. * The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. * The subject must be between 18 and 40 years of age. * The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 Diopters (D) to -8.00 D in each eye. * The subject's refractive cylinder must be no more than -1.00 D cylindrical correction in each eye after vertexing to the corneal plane. * The subject must have best corrected visual acuity of 0.20 or better in each eye. * 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. * The subject must be using digital devices (any combination of computers, tablets, smart phones etc.) for at least 8 hours over the course of a typical day. * The subject should own a wearable pair of spectacles and wear them the day of the baseline visit. * 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. * The subject must meet normal eligibility conditions of binocular vision tests. * The subject may not have any double vision at near with their habitual contact lens correction.
Exclusion criteria
* Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). * Any ocular or systemic allergies or diseases that may interfere with contact lens wear (at the investigator's discretion). * Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion). * Use of any medication that causes side effects similar to side effects experienced when using digital devices, such as a subject reporting headaches associated with birth control pills (at the investigator's discretion). * Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease. * Any active ocular infection. * Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion. * Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.). * 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. * Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. * Any known hypersensitivity or allergic reaction to the study products. * Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment. * History of binocular vision abnormality or strabismus. * Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall CLUE Comfort | Up to 4-Week Follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Haze | Up to 4-Week Follow-up | Time to haze measure the maximum time a contact lens wearers can keep their eye open without their vision becoming hazy. It was a measure of how the drying of the contact lens surface with open eyes affects vision. |
| Average Wear Time | Up to 4-Week Follow-up | Average lens wear time with the study lenses were recorded in hour at each follow-up visit. |
| Overall CLUE Handling | Up to 4-Week Follow-up | Overall Handling 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. |
| Difference in Total Device Use Time and Comfortable Wear Time During Device Use | Up to 4-Week Follow-up | Subjects reported the total duration of their digital device use and comfortable lens wear time during digital device use. |
| Comfort at the End of the Day | Up to 4-Week Follow-up | Subjects graded the comfort level at the end of the day using 5- point scale (1=excellence, 2=very good, 3=good, 4=fair and 5=poor). The average end of day comfort grade was reported for each lens type. |
| Average Comfortable Wear Time | Up to 4-Week Follow-up | Average comfortable lens wear time with the study lenses were recorded in hour at each follow-up visit. |
Countries
Canada
Participant flow
Recruitment details
A total of 200 subjects were enrolled into this study. Of the enrolled, 171 subjects were randomized and dispensed at least one study lens. Of the dispensed subjects, 127 completed the study while 44 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Subjects All subjects enrolled in the study, i.e. signed informed consent form. | 200 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Adverse Event | 1 | 10 |
| Period 1 | Lens Discomfort | 2 | 2 |
| Period 1 | Lost to Follow-up | 0 | 2 |
| Period 1 | Protocol Violation | 0 | 1 |
| Period 1 | Unsatisfactory Lens Fitting | 0 | 1 |
| Period 1 | Withdrawal by Subject | 6 | 6 |
| Period 2 | Adverse Event | 3 | 5 |
| Period 2 | Unsatisfactory Lens Fitting | 0 | 1 |
| Period 2 | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | All Enrolled Subjects |
|---|---|
| Age, Continuous | 23.9 Years STANDARD_DEVIATION 4.92 |
| Race/Ethnicity, Customized Asian | 78 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Other | 7 Participants |
| Race/Ethnicity, Customized White | 114 Participants |
| Region of Enrollment Canada | 200 Participants |
| Sex: Female, Male Female | 140 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 171 | 0 / 171 |
| other Total, other adverse events | 18 / 171 | 29 / 171 |
| serious Total, serious adverse events | 0 / 171 | 0 / 171 |
Outcome results
Primary
Overall CLUE Comfort
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.
Time frame: Up to 4-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Overall CLUE Comfort | 65.0 Units on a Scale | Standard Deviation 22.47 |
| Samfilcon A | Overall CLUE Comfort | 60.3 Units on a Scale | Standard Deviation 23.71 |
98% CI: [1.3, 8.73]Bayesian hierarchical model
Secondary
Average Comfortable Wear Time
Average comfortable lens wear time with the study lenses were recorded in hour at each follow-up visit.
Time frame: Up to 4-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Average Comfortable Wear Time | 9.6 Hours | Standard Deviation 3.73 |
| Samfilcon A | Average Comfortable Wear Time | 9.6 Hours | Standard Deviation 3.86 |
95% CI: [-0.47, 0.57]Bayesian hierarchical model
Secondary
Average Wear Time
Average lens wear time with the study lenses were recorded in hour at each follow-up visit.
Time frame: Up to 4-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Average Wear Time | 11.5 Hours | Standard Deviation 3.57 |
| Samfilcon A | Average Wear Time | 11.55 Hours | Standard Deviation 3.57 |
95% CI: [-0.27, 0.16]Bayesian hierarchical model
Secondary
Comfort at the End of the Day
Subjects graded the comfort level at the end of the day using 5- point scale (1=excellence, 2=very good, 3=good, 4=fair and 5=poor). The average end of day comfort grade was reported for each lens type.
Time frame: Up to 4-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Comfort at the End of the Day | 2.6 units on a scale | Standard Deviation 1.21 |
| Samfilcon A | Comfort at the End of the Day | 2.7 units on a scale | Standard Deviation 1.26 |
95% CI: [0.99, 1.79]Bayesian multinomial model
Secondary
Difference in Total Device Use Time and Comfortable Wear Time During Device Use
Subjects reported the total duration of their digital device use and comfortable lens wear time during digital device use.
Time frame: Up to 4-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Difference in Total Device Use Time and Comfortable Wear Time During Device Use | 1.2 Hours | Standard Deviation 1.74 |
| Samfilcon A | Difference in Total Device Use Time and Comfortable Wear Time During Device Use | 1.2 Hours | Standard Deviation 1.81 |
95% CI: [-0.36, 0.26]Bayesian hierarchical model
Secondary
Overall CLUE Handling
Overall Handling 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.
Time frame: Up to 4-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Overall CLUE Handling | 66.7 Units on a Scale | Standard Deviation 18.58 |
| Samfilcon A | Overall CLUE Handling | 52.9 Units on a Scale | Standard Deviation 22.99 |
95% CI: [10.34, 17.05]Bayesian hierarchical model
Secondary
Time to Haze
Time to haze measure the maximum time a contact lens wearers can keep their eye open without their vision becoming hazy. It was a measure of how the drying of the contact lens surface with open eyes affects vision.
Time frame: Up to 4-Week Follow-up
Population: All subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Time to Haze | 9.4 seconds | Standard Deviation 5.01 |
| Samfilcon A | Time to Haze | 9.7 seconds | Standard Deviation 5.65 |
95% CI: [-1, 0.25]Bayesian hierarchical model