Comfort, Overall Vision, Visual Acuity
Conditions
Brief summary
To evaluate the impact of a new contact lens hydration process
Detailed description
To evaluate the impact on clinical performance of senofilcon A lenses manufactured using an alternate hydration process and compare the performance with senofilcon A lenses manufactured using the current process.
Interventions
DEVICEsenofilcon A
Control, senfilcon A
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 at least 18 and not more than 70 years of age. * The subject's refractive cylinder must be \< 0.75D in each eye. * The subject must have best corrected visual acuity of 20/25 or better in each eye. * The subject must demonstrate adequate mobility and 20/30 vision OD and OS with the study contact lenses. * The subject must be a habitual and adapted wearer of ACUVUE® OASYS® Brand contact lens in both eyes. * The subject must have normal eyes (i.e., no ocular medications or infections of any type). * The subject's required spherical contact lens prescription must be in the range of -0.50 to -9.00D in each eye.
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. * Any systemic disease, autoimmune disease, or use of medication, that may interfere with contact lens wear. * Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry. * Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.). * 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. * Any known hypersensitivity or allergic reaction to OPTI-FREE® PureMoist® Contact Lens Solution. * Any ocular infection. * Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. * Monovision or multi-focal contact lens correction. * Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. * History of binocular vision abnormality or strabismus. * Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self report). * Suspicion of or recent history of alcohol or substance abuse. * History of serious mental illness. * History of seizures. * Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Overall Comfort (Using CLUE ) | 2 weeks | Contact Lens User Experience Comfort scores (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. |
| Subjective Overall Vision (Using CLUE ) | 2 weeks | Contact Lens User Experience Vision scores (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. |
Countries
United States
Participant flow
Pre-assignment details
A total of 136 subjects were enrolled in the study; 9 subjects did not meet the inclusion and exclusion criteria and not randomized. Of the 127 randomized subjects, 6 were prematurely discontinued from the study and 2 were excluded from the analysis due to major protocol deviations.
Participants by arm
| Arm | Count |
|---|---|
| Control/Test Subjects who received Control lens, senofilcon A for the first two weeks of the study and then received Test lens, senofilcon A in the last two weeks of the study. | 64 |
| Test/Control Subjects who received Test lens, senofilcon A for the first two weeks of the study and then received Control lens, senofilcon A in the last two weeks of the study. | 63 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Physician Decision | 1 | 0 |
| First Intervention | Subject was not compliant | 1 | 1 |
| First Intervention | Withdrawal by Subject | 1 | 0 |
| Second Intervention | Protocol Violation | 0 | 1 |
| Second Intervention | Unsatisfactory Lens fitting | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Control/Test | Test/Control |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 2 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 125 Participants | 62 Participants | 63 Participants |
| Age, Continuous | 35.2 years STANDARD_DEVIATION 9.6 | 35.5 years STANDARD_DEVIATION 9.73 | 35.0 years STANDARD_DEVIATION 9.63 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 117 Participants | 61 Participants | 56 Participants |
| Region of Enrollment United States | 127 participants | 64 participants | 63 participants |
| Sex: Female, Male Female | 102 Participants | 52 Participants | 50 Participants |
| Sex: Female, Male Male | 25 Participants | 12 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 64 | 0 / 63 |
| serious Total, serious adverse events | 0 / 64 | 0 / 63 |
Outcome results
Primary
Subjective Overall Comfort (Using CLUE )
Contact Lens User Experience Comfort scores (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.
Time frame: 2 weeks
Population: Includes all subjects who completed all visits and did not have any major protocol deviation impacting the primary outcomes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control, Senofilcon A | Subjective Overall Comfort (Using CLUE ) | 63.3 units on a scale | Standard Deviation 24.85 |
| Test, Senofilcon A | Subjective Overall Comfort (Using CLUE ) | 65.0 units on a scale | Standard Deviation 26.75 |
Primary
Subjective Overall Vision (Using CLUE )
Contact Lens User Experience Vision scores (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.
Time frame: 2 weeks
Population: Includes all subjects who completed all visits and did not have any major protocol deviation impacting the primary outcomes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control, Senofilcon A | Subjective Overall Vision (Using CLUE ) | 65.2 units on a scale | Standard Deviation 20.75 |
| Test, Senofilcon A | Subjective Overall Vision (Using CLUE ) | 65.2 units on a scale | Standard Deviation 20.12 |