Visual Performance
Conditions
Brief summary
This study will occur in two non-dispensing phases: Phase 1 is a non-randomized, non-masked, non-dispensing study where subjects will wear their own contact lenses for approximately 1 hour. Phase 2 is a controlled, randomized, double-masked, contralateral non-dispensing study where the study lenses will be worn in a daily wear modality for approximately 3 hours.
Interventions
DEVICETRP-200
JJVC Investigational Contact Lens
DEVICEACUVUE Oasys 1-Day
JJVC Marketed Contact Lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
In Phase 2, subjects will be randomized to a contralateral sequence where the study lenses will be worn throughout the duration of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. 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. For Phase I be between 18-39 (inclusive) years of age at the time of screening. 4. For Phase II be between 18 and 70 (inclusive) years of age at the time of screening. 5. By self-report, habitually wear spherical silicone hydrogel soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days. 6. Possess a wearable pair of spectacles that provide correction for distance vision. 7. Habitual spherical contact lens powers must be between -1.00 D and -6.00 D (inclusive) in each eye. 8. For Phase I, habitual contact lenses must provide at least 20/20 acuity OD and OS. 9. For Phase II, the spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 D and -6.00 D (inclusive) in each eye. 10. For Phase II, the magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be between 0.00 D and 1.00 D (inclusive) in each eye. 11. For Phase II, the best corrected, monocular, distance visual acuity must be 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. Be currently pregnant or lactating. 2. Be currently using any ocular medications or have any ocular infection of any type. 3. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. 4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months. 5. Be currently wearing monovision or multifocal contact lenses. 6. Be currently wearing lenses in an extended wear modality. 7. Have participated in a contact lens or lens care product clinical trial within 30 days prior to study enrollment. 8. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site. 9. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). 10. Have a history of strabismus or amblyopia. 11. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions. 12. Have had any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.). 13. Have signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar). 14. Have a history of eyelid injury, surgery or procedure that resulted in abnormal eyelid position or movement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Photopic Contrast Sensitivity at 6 Cpd | Post screening up to 1 hour during Phase 1 | Photopic (\ 120 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2. |
| Mesopic Contrast Sensitivity at 6 Cpd | Post screening up to 1 hour during Phase 1 | Mesopic (\ 3 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2. |
| Photopic Resolution Acuity Using Landolt C's With a Glare Source | At least 5 minutes post lens fitting up to 2 hours during Phase 2 | Photopic resolution acuity using Landolt C's was measured separately for the right (OD) and left (OS) eyes, using an arcminute scale under bright light conditions (\ 120 cd/m2) with a broadband glare source. The photopic resolution acuity on arcminute scale was converted to logMAR scale for the analysis purpose using a log transformation. Lower values indicate better acuity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Photopic Contrast Sensitivity With a Glare Source | At least 5 minutes post lens fitting up to 2 hours during Phase 2 | Photopic contrast sensitivity was measured for the right (OD) and left (OS) eyes separately under bright light conditions (\ 120 cd/m2) with a broadband glare source. Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. The area under the log contrast sensitivity function (AULCSF) was derived for the analysis using the trapezoidal rule. Higher AULCSF values indicate better contrast sensitivity. |
| Mesopic Contrast Sensitivity With a Glare Source | At least 5 minutes post lens fitting up to 2 hours during Phase 2 | Mesopic contrast sensitivity was measured for the right (OD) and left (OS) eyes separately under dim light conditions (less than or equal 3 cd/m2) with a broadband glare source. Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. The area under the log contrast sensitivity function (AULCSF) was derived for the analysis using the trapezoidal rule. Higher AULCSF values indicate better contrast sensitivity. |
Countries
United States
Participant flow
Recruitment details
In Phase I, 20 subjects were enrolled and completed this Phase. In Phase 2, 62 subjects were enrolled. Of those enrolled in Phase 2, all 62 were dispensed at least 1 study lens. Of those dispensed, 60 subjects completed Phase 2 while 2 subjects were discontinued from Phase 2. Phase I and Phase II are mutually exclusive. Data collected from Phase I was used to validate the glare light source for evaluating the primary and secondary endpoints in Phase II.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1 Phase 1 was a non-randomized design where subjects wore their own contact lenses | 20 |
| Phase 2 Phase 2 was a randomized design with two test articles | 62 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Phase 2 | Subject enrolled in error | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Phase 2 | Total | Phase 1 |
|---|---|---|---|
| Age, Continuous | 38.6 years STANDARD_DEVIATION 14.07 | 35.2 years STANDARD_DEVIATION 13.88 | 24.7 years STANDARD_DEVIATION 5.62 |
| Race/Ethnicity, Customized Asian | 4 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants | 9 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 51 Participants | 67 Participants | 16 Participants |
| Region of Enrollment United States | 62 Participants | 82 Participants | 20 Participants |
| Sex: Female, Male Female | 50 Participants | 66 Participants | 16 Participants |
| Sex: Female, Male Male | 12 Participants | 16 Participants | 4 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 | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 4 | 0 / 2 | 0 / 1 | 0 / 1 | 0 / 4 | 0 / 2 | 0 / 3 | 0 / 62 | 0 / 62 |
| other Total, other adverse events | 0 / 3 | 0 / 4 | 0 / 2 | 0 / 1 | 0 / 1 | 0 / 4 | 0 / 2 | 0 / 3 | 0 / 62 | 0 / 62 |
| serious Total, serious adverse events | 0 / 3 | 0 / 4 | 0 / 2 | 0 / 1 | 0 / 1 | 0 / 4 | 0 / 2 | 0 / 3 | 0 / 62 | 0 / 62 |
Outcome results
Primary
Mesopic Contrast Sensitivity at 6 Cpd
Mesopic (\ 3 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2.
Time frame: Post screening up to 1 hour during Phase 1
Population: All subjects completed Phase 1 without a major protocol deviation excluding subjects recording an increase in mesopic contrast sensitivity with the glare source.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| With Glare | Mesopic Contrast Sensitivity at 6 Cpd | 0.70 Log Unit | Standard Deviation 0.328 |
| Without Glare | Mesopic Contrast Sensitivity at 6 Cpd | 1.29 Log Unit | Standard Deviation 0.498 |
Comparison: The sample size was chosen based on resources in conjunction, subject matter experts, and any available literature. To help ensure the glare source intensity, a small pilot investigation per the ANSI Z80.12-2007 standard was interpreted to be about 20 subjects to complete Phase 1, which should be sufficient to evaluate the mean mesopic contrast sensitivity with and without the glare source.95% CI: [-0.81, -0.36]Linear Mixed Model
Primary
Photopic Contrast Sensitivity at 6 Cpd
Photopic (\ 120 cd/m2) contrast sensitivity at 6 cpd was measured on the right eye only with and without a broadband glare source (with glare followed after without glare). Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. If the reduction (indicating worse contrast sensitivity) in the estimated mean due to the glare source was about 0.1 log units, then it can be concluded that the glare light source was effective and the study can move to Phase 2.
Time frame: Post screening up to 1 hour during Phase 1
Population: All subjects that completed Phase 1 without a major protocol deviation excluding subjects recording an increase in photopic contrast sensitivity with the glare source.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| With Glare | Photopic Contrast Sensitivity at 6 Cpd | 1.46 Log Unit | Standard Deviation 0.317 |
| Without Glare | Photopic Contrast Sensitivity at 6 Cpd | 1.91 Log Unit | Standard Deviation 0.373 |
Comparison: The sample size was chosen based on resources in conjunction, subject matter experts, and any available literature. To help ensure the glare source intensity, a small pilot investigation per the ANSI Z80.12-2007 standard was interpreted to be about 20 subjects to complete Phase 1, which should be sufficient to evaluate the mean photopic contrast sensitivity with and without the glare source.95% CI: [-0.7, -0.21]Linear Mixed Model
Primary
Photopic Resolution Acuity Using Landolt C's With a Glare Source
Photopic resolution acuity using Landolt C's was measured separately for the right (OD) and left (OS) eyes, using an arcminute scale under bright light conditions (\ 120 cd/m2) with a broadband glare source. The photopic resolution acuity on arcminute scale was converted to logMAR scale for the analysis purpose using a log transformation. Lower values indicate better acuity.
Time frame: At least 5 minutes post lens fitting up to 2 hours during Phase 2
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| With Glare | Photopic Resolution Acuity Using Landolt C's With a Glare Source | 0.01 logMAR | Standard Deviation 0.191 |
| Without Glare | Photopic Resolution Acuity Using Landolt C's With a Glare Source | -0.01 logMAR | Standard Deviation 0.158 |
Comparison: Given no historical data is available, the sample size was not determined based on any empirical sample size calculation. A power analysis was conducted using a paired sample t-test (exact method) with a 2-sided type I error rate 0.05 to estimate statistical power based on different assumptions. The power analysis showed that the statistical power for testing superiority would be approximately 80% or higher with the effect size of -0.05 (mean difference: Test minus Control).95% CI: [-0.029, 0.068]Linear Mixed Model
Secondary
Mesopic Contrast Sensitivity With a Glare Source
Mesopic contrast sensitivity was measured for the right (OD) and left (OS) eyes separately under dim light conditions (less than or equal 3 cd/m2) with a broadband glare source. Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. The area under the log contrast sensitivity function (AULCSF) was derived for the analysis using the trapezoidal rule. Higher AULCSF values indicate better contrast sensitivity.
Time frame: At least 5 minutes post lens fitting up to 2 hours during Phase 2
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| With Glare | Mesopic Contrast Sensitivity With a Glare Source | 0.71 Units on a scale | Standard Deviation 0.212 |
| Without Glare | Mesopic Contrast Sensitivity With a Glare Source | 0.72 Units on a scale | Standard Deviation 0.232 |
Secondary
Photopic Contrast Sensitivity With a Glare Source
Photopic contrast sensitivity was measured for the right (OD) and left (OS) eyes separately under bright light conditions (\ 120 cd/m2) with a broadband glare source. Testing included 8 reversals with the last 4 being averaged to provide the contrast threshold. The area under the log contrast sensitivity function (AULCSF) was derived for the analysis using the trapezoidal rule. Higher AULCSF values indicate better contrast sensitivity.
Time frame: At least 5 minutes post lens fitting up to 2 hours during Phase 2
Population: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| With Glare | Photopic Contrast Sensitivity With a Glare Source | 1.18 Units on a scale | Standard Deviation 0.248 |
| Without Glare | Photopic Contrast Sensitivity With a Glare Source | 1.21 Units on a scale | Standard Deviation 0.25 |