Refractive Error Correction
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
DEVICEControl/Test
Subjects that are between the ages of 18-70 years old and habitual wearers of hydrogel daily disposable contact lenses will be randomly assigned to Control/Test sequence with a 7 to 9-day washout period in between treatments
DEVICETest/Control
Subjects that are between the ages of 18-70 years old and habitual wearers of hydrogel daily disposable contact lenses will be randomly assigned to Test/Control sequence with a 7 to 9-day washout period in between treatments
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
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 of investigational clinic (e.g., Investigator, Coordinator, Technician).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort Scores | 1-Week Follow-up | Subjective assessment of comfort will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers. |
| Overall Vision Score | 1-Week Follow-up | Subjective assessment of vision will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers. |
Countries
United States
Participant flow
Recruitment details
On July 06, 2018 Johnson & Johnson Vision terminated this study prematurely after lens testing revealed that the lens thickness in the mid-periphery of the lens were thinner than the lens design targets. As of this date only 3 subjects were enrolled at 1 site.
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Subjects All subjects enrolled into th study | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Study Terminated | 2 | 1 |
Baseline characteristics
| Characteristic | All Enrolled Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacfic Islander | 1 Participants |
| Race/Ethnicity, Customized White | 1 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
Overall Comfort Scores
Subjective assessment of comfort will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.
Time frame: 1-Week Follow-up
Population: Study terminated early. No data was analyzed.
Primary
Overall Vision Score
Subjective assessment of vision will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.
Time frame: 1-Week Follow-up
Population: Study terminated early. No data was analyzed.