Ametropia
Conditions
Brief summary
This is a single-site, two-visit, contralateral, non-dispensing, randomized, controlled and subject-masked study to measure potential benefits of the new UV blocker.
Interventions
Test Lens
DEVICEsenofilcon A
Control 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 65 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 65 (inclusive) years of age at the time of screening. 4. Be a current spherical soft silicone hydrogel contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report. 5. The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 through -4.50 D in each eye. 6. The subject has a best corrected visual acuity of 20/25 or better in each eye.
Exclusion criteria
1. Currently pregnant or breastfeeding. 2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear. 3. Any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable. 4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia. 5. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.). 6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 7. Multifocal, toric or extended wear contact lens correction. 8. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. 9. History of binocular vision abnormality or strabismus. 10. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report. 11. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). 12. Any ocular infection. 13. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Two-Point Light Spread Function | Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2 | The two-point light spread function was assessed at visit 2 for each subject eye under two conditions with a distance filter and without a distance filter. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Two-point light spread function is defined that the as the minimum distance (mm) that two points of light are completely distinct. Measurements for this metric are positive. Smaller distances indicate better lens performance. The average distance for each lens type and light source combination was reported across age groups. |
| Halos | Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2 | The appearance of Halos was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Halos were quantified as the diameter (mm) of the outer edges of the Halo. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups. |
| Starburts | Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2 | The appearance of starbursts was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Starbursts are defined as the diameter (mm) of the light's lateral spread. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glare Disability Threshold | Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1 | The Glare disability threshold was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Subjects were exposed to a target stimulus for 2 seconds; before the measurement was taken the annulus was set to a level below that which would cause the target stimulus to be veiled. The experimenter would then adjust the intensity of the annulus until subjects could no longer see the target stimulus. Subjects would indicate this by pressing a buzzer. Glare disability thresholds take on positive values, where higher values indicate better lens performance. The average glare disability level (change in log relative energy) for each lens type was reported across age groups. |
| Heterochromatic Contrast Threshold | Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1 | Heterochromatic Contrast Threshold was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Heterochromatic contrast thresholds are measured as thresholds to a variable wavelength central target presented on a short-wave (460nm) sky-light background. Thresholds are positive values, where higher values indicate better lens performance. The average threshold each lens type was reported across age groups. |
| Photostress Recovery Time | Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1 | Photostress Recovery (PR) Time (seconds) was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Subjects are exposed to a target, once the target was able to be comfortable viewed by the subject, a bright bleaching light covered it. As the afterimage fades, participants will gradually be able to re-gain sight of the target. PR time will be recorded as the time it takes following exposure to the bleaching light to regain sight of the target. PR Times are positive values where smaller times indicate better lens performance. The average PR Time (seconds) for each lens type was reported across age groups. |
| Glare Discomfort | Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1 | The Glare discomfort (change in palpebral fissure height) was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Glare discomfort can take on negative and positive values, where smaller values indicate better lens performance. The average glare discomfort (change in palpebral fissure height) for each lens type was reported across age groups. |
Countries
United States
Participant flow
Recruitment details
A total of 62 subjects were into this study. Of those enrolled, 60 were assigned and administered a study lens. Two subjects were enrolled but not administered a study lens. All 60 subjects completed the study.
Pre-assignment details
Subjects were stratified into two age groups: 18-39 and 40-65 using a 2:1 allocation. Subjects were randomized at each visit using a contralateral design.
Participants by arm
| Arm | Count |
|---|---|
| Safety Population All Subjects that were Fit with at least one study lens. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Safety Population |
|---|---|
| Age, Continuous | 34.8 years STANDARD_DEVIATION 11.22 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Count of Participants |
| Race/Ethnicity, Customized Black or African American | 22 Count of Participants |
| Race/Ethnicity, Customized Other | 2 Count of Participants |
| Race/Ethnicity, Customized White | 35 Count of Participants |
| Region of Enrollment United States | 60 Participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Halos
The appearance of Halos was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Halos were quantified as the diameter (mm) of the outer edges of the Halo. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups.
Time frame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2
Population: All subjects that completed the study without a major protocol deviation impacting any primary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testing With Additional Light Source | Halos | 29.20 mm | Standard Deviation 15.777 |
| Control With Additional Source | Halos | 52.57 mm | Standard Deviation 22.758 |
| Test Without Additional Light Source | Halos | 39.09 mm | Standard Deviation 14.524 |
| Control Without Additional Light Source | Halos | 46.73 mm | Standard Deviation 18.355 |
95% CI: [-13.16, -4.55]Linear Mixed Model
95% CI: [-29.24, -20.62]Linear Mixed Model Analysis
Primary
Starburts
The appearance of starbursts was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Starbursts are defined as the diameter (mm) of the light's lateral spread. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups.
Time frame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2
Population: Subjects that have completed all study visits without a major protocol deviation impacting a primary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testing With Additional Light Source | Starburts | 45.66 mm | Standard Deviation 24.228 |
| Control With Additional Source | Starburts | 75.12 mm | Standard Deviation 27.37 |
| Test Without Additional Light Source | Starburts | 55.78 mm | Standard Deviation 23.037 |
| Control Without Additional Light Source | Starburts | 69.60 mm | Standard Deviation 25.914 |
95% CI: [-31.66, -25.46]Linear Mixed Model
95% CI: [-20.48, -10.27]Linear Mixed Model
Primary
Two-Point Light Spread Function
The two-point light spread function was assessed at visit 2 for each subject eye under two conditions with a distance filter and without a distance filter. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Two-point light spread function is defined that the as the minimum distance (mm) that two points of light are completely distinct. Measurements for this metric are positive. Smaller distances indicate better lens performance. The average distance for each lens type and light source combination was reported across age groups.
Time frame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2
Population: All subjects that completed the study without a major protocol deviation impacting any primary endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Testing With Additional Light Source | Two-Point Light Spread Function | with distance filter | 5.36 mm | Standard Deviation 3.132 |
| Testing With Additional Light Source | Two-Point Light Spread Function | Without Dustance Filter | 2.29 mm | Standard Deviation 1.129 |
| Control With Additional Source | Two-Point Light Spread Function | Without Dustance Filter | 3.37 mm | Standard Deviation 1.214 |
| Control With Additional Source | Two-Point Light Spread Function | with distance filter | 6.71 mm | Standard Deviation 2.521 |
| Test Without Additional Light Source | Two-Point Light Spread Function | with distance filter | 6.47 mm | Standard Deviation 3.304 |
| Test Without Additional Light Source | Two-Point Light Spread Function | Without Dustance Filter | 3.05 mm | Standard Deviation 1.205 |
| Control Without Additional Light Source | Two-Point Light Spread Function | with distance filter | 7.48 mm | Standard Deviation 3.149 |
| Control Without Additional Light Source | Two-Point Light Spread Function | Without Dustance Filter | 3.78 mm | Standard Deviation 1.472 |
Comparison: Without Distance Filter95% CI: [-1.01, -0.36]Linear Mixed Model
Comparison: Without Distance Filter95% CI: [-1.45, -0.81]Linear Mixed Model Analysis
Secondary
Glare Disability Threshold
The Glare disability threshold was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Subjects were exposed to a target stimulus for 2 seconds; before the measurement was taken the annulus was set to a level below that which would cause the target stimulus to be veiled. The experimenter would then adjust the intensity of the annulus until subjects could no longer see the target stimulus. Subjects would indicate this by pressing a buzzer. Glare disability thresholds take on positive values, where higher values indicate better lens performance. The average glare disability level (change in log relative energy) for each lens type was reported across age groups.
Time frame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1
Population: All subjects that completed the study without a major protocol deviation impacting any primary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testing With Additional Light Source | Glare Disability Threshold | 0.98 log units | Standard Deviation 0.166 |
| Control With Additional Source | Glare Disability Threshold | 1.16 log units | Standard Deviation 0.14 |
95% CI: [0.15, 0.23]Linear Mixed Model Analysis
Secondary
Glare Discomfort
The Glare discomfort (change in palpebral fissure height) was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Glare discomfort can take on negative and positive values, where smaller values indicate better lens performance. The average glare discomfort (change in palpebral fissure height) for each lens type was reported across age groups.
Time frame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1
Population: Subjects that completed all study visits wihtout a major protocol deviation impacting a primary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testing With Additional Light Source | Glare Discomfort | 2.26 mm | Standard Deviation 1.249 |
| Control With Additional Source | Glare Discomfort | 2.90 mm | Standard Deviation 1.569 |
95% CI: [-1.07, -0.15]Linear Mixed Model
Secondary
Heterochromatic Contrast Threshold
Heterochromatic Contrast Threshold was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Heterochromatic contrast thresholds are measured as thresholds to a variable wavelength central target presented on a short-wave (460nm) sky-light background. Thresholds are positive values, where higher values indicate better lens performance. The average threshold each lens type was reported across age groups.
Time frame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1
Population: Subjects that completed all study visits without a major protocol deviation impacting a primary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testing With Additional Light Source | Heterochromatic Contrast Threshold | 1.01 log units | Standard Deviation 0.17 |
| Control With Additional Source | Heterochromatic Contrast Threshold | 1.24 log units | Standard Deviation 0.164 |
95% CI: [0.14, 0.23]Linear Mixed Model Analysis
Secondary
Photostress Recovery Time
Photostress Recovery (PR) Time (seconds) was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Subjects are exposed to a target, once the target was able to be comfortable viewed by the subject, a bright bleaching light covered it. As the afterimage fades, participants will gradually be able to re-gain sight of the target. PR time will be recorded as the time it takes following exposure to the bleaching light to regain sight of the target. PR Times are positive values where smaller times indicate better lens performance. The average PR Time (seconds) for each lens type was reported across age groups.
Time frame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1
Population: Subjects that completed all study visits without a major protocol deviation impacting a primary endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testing With Additional Light Source | Photostress Recovery Time | 8.83 seconds | Standard Deviation 8.668 |
| Control With Additional Source | Photostress Recovery Time | 17.28 seconds | Standard Deviation 15.23 |
95% CI: [0.46, 0.65]Generalized linear mixed model