Myopia
Conditions
Brief summary
This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.
Interventions
DEVICEetafilcon A with novel molding process
TEST Lens
DEVICEetafilcon A with current molding process
CONTROL Lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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. 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. Must be at least 18 and not more than 70 years of age (including 70) at the time of screening. 4. The subject must be a habitual and adapted wearer of hydrogel daily disposable brand contact lens in both eyes (at least 1 month of daily wear). 5. The subject must have normal eyes (i.e., no ocular medications or infections of any type). 6. The subject's required spherical contact lens prescription must be in the range of -1.00 to -4.50 D in each eye. 7. The subject's refractive cylinder must be \< 0.75 D in each eye. 8. The subject must have 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. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). 2. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear. 3. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.). 4. Any ocular infection. 5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 6. Monovision or multi-focal contact lens correction. 7. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. 8. History of binocular vision abnormality or strabismus. 9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report). 10. Suspicion of or recent history of alcohol or substance abuse. 11. History of serious mental illness. 12. History of seizures. 13. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician) 14. 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. 15. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale. 16. 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 |
|---|---|---|
| Overall Comfort Scores | 1-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. |
| Overall Vision Scores | 1-week Follow-up | Overall vision was assessed using the CLUE questionnaire. CLUE is a validated 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 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 |
|---|---|---|
| Average Daily Wear Time | 1-week Follow-up | Average daily wear time was calculated as the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day, at 1-week follow-up evaluation. Higher wear times indicate better lens performance. The average wear time was reported for each lens type. |
| LLHC LogMAR Visual Performance | 1-week Follow-up | Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under low luminance and high contrast conditions (LLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye at 1-week follow-up. The average visual performance was reported for each lens type. |
| HLLC LogMAR Visual Performance | 1-week Follow-up | Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under high luminance and low contrast conditions (HLLC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye at 1-week follow-up. The average visual performance was reported for each lens type. |
Countries
United States
Participant flow
Recruitment details
A total of 268 subjects were enrolled in this study. Of those enrolled, 263 dispensed at least one study lens while, 5 subjects failed to meet all eligibility criteria. Of those dispensed subjects, 252 subjects completed the study while, 11 subjects were discontinued from the study.
Participants by arm
| Arm | Count |
|---|---|
| Dispensed Subject All subjects dispensed a study lens. | 263 |
| Total | 263 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Adverse Event | 0 | 2 |
| Period 1 | Lost to Follow-up | 0 | 1 |
| Period 1 | Non Compliance to Protocol | 2 | 1 |
| Period 1 | Unsatisfactory Lens Fitting due to Test Article | 2 | 0 |
| Period 1 | Withdrawal by Subject | 0 | 1 |
| Period 2 | failed to meet all eligibility creiteria | 1 | 0 |
| Period 2 | Unsatisfactory Lens Fitting due to Test Article | 0 | 1 |
Baseline characteristics
| Characteristic | Dispensed Subject |
|---|---|
| Age, Continuous | 31.6 years STANDARD_DEVIATION 8.5 |
| Race/Ethnicity, Customized Asian | 13 participants |
| Race/Ethnicity, Customized Black or African American | 17 participants |
| Race/Ethnicity, Customized Other | 5 participants |
| Race/Ethnicity, Customized White | 228 participants |
| Region of Enrollment United States | 263 Participants |
| Sex: Female, Male Female | 186 Participants |
| Sex: Female, Male Male | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 263 | 0 / 263 |
| other Total, other adverse events | 0 / 263 | 0 / 263 |
| serious Total, serious adverse events | 0 / 263 | 0 / 263 |
Outcome results
Primary
Overall Comfort Scores
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: 1-week Follow-up
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Overall Comfort Scores | 59.9 unit on a scale | Standard Deviation 24.21 |
| Control | Overall Comfort Scores | 60.8 unit on a scale | Standard Deviation 24.69 |
98% CI: [-4.53, 3.85]Bayesian repeated measurement model
Primary
Overall Vision Scores
Overall vision was assessed using the CLUE questionnaire. CLUE is a validated 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 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: 1-week Follow-up
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Overall Vision Scores | 64.2 unit on a scale | Standard Deviation 20.06 |
| Control | Overall Vision Scores | 66.5 unit on a scale | Standard Deviation 19.94 |
98% CI: [-5.36, 0.61]Bayesian repeated measurement model
Secondary
Average Daily Wear Time
Average daily wear time was calculated as the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day, at 1-week follow-up evaluation. Higher wear times indicate better lens performance. The average wear time was reported for each lens type.
Time frame: 1-week Follow-up
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Average Daily Wear Time | 14.3 Hours | Standard Deviation 1.92 |
| Control | Average Daily Wear Time | 14.4 Hours | Standard Deviation 1.82 |
95% CI: [-0.22, 0.1]Bayesian repeated measurement model
Secondary
HLLC LogMAR Visual Performance
Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under high luminance and low contrast conditions (HLLC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye at 1-week follow-up. The average visual performance was reported for each lens type.
Time frame: 1-week Follow-up
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | HLLC LogMAR Visual Performance | 0.062 logMAR | Standard Deviation 0.1209 |
| Control | HLLC LogMAR Visual Performance | 0.065 logMAR | Standard Deviation 0.1176 |
95% CI: [-0.009, 0.002]Bayesian repeated measurement model
Secondary
LLHC LogMAR Visual Performance
Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under low luminance and high contrast conditions (LLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye at 1-week follow-up. The average visual performance was reported for each lens type.
Time frame: 1-week Follow-up
Population: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | LLHC LogMAR Visual Performance | -0.059 logMAR | Standard Deviation 0.1123 |
| Control | LLHC LogMAR Visual Performance | -0.060 logMAR | Standard Deviation 0.1176 |
95% CI: [-0.005, 0.006]Bayesian repeated measurement random-eff