Visual Disorder
Conditions
Brief summary
This study is a multi-site, 5-visit dispensing, bilateral double-arm parallel group design, double-masked clinical trial using an investigational contact lens and a marketed contact lens. The objective is to evaluate comfort of the contact lenses when worn on a daily wear modality.
Interventions
DEVICEInvestigational Contact Lenses (Test)
DEVICEMarketed Contact Lenses (Control)
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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 between 18 to 40 years of age at the time of consent. * The subject's vertexed spherical equivalent distance refraction must be in the range of +8.00 to -12.00 in each eye. * Subject wears habitual contact lenses a minimum of 4 days per week, eight hours per day. * The subject must have best corrected visual acuity of 20/30 or better in each eye. * The subject must be a habitual frequent replacement daily wear spherical silicone hydrogel soft contact lens wearer in both eyes. * The subject must be able to wear contact lenses for a minimum of 8 hours each day during the study. * The subject must have normal eyes (i.e., no ocular medications or infections of any type).
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, which may interfere with contact lens wear. * Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution. * Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion. * Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (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 ocular infection. * Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. * Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptable Lens Fitting | Up to 4 Week Follow-up | Lens fit was assessed and recorded for each subject and eye at post lens fitting, 1-, 2-, 3- and 4- week follow-up evaluations. Lens fit was a binary response acceptable and unacceptable lens fit. The proportion of eyes with acceptable lens fitting at post lens fit and across all four follow-ups was combined and reported. |
| Overall Comfort | Up to 4 Week Follow-up | Clue 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. CLUE Comfort was assessed at 1-, 2-, 3 and 4- week Follow-up evaluations. The average CLUE comfort score for each lens was reported for each visit. |
Countries
United States
Participant flow
Pre-assignment details
A total of 150 subjects were enrolled in this study. All subjects enrolled into the study were dispensed a study lens. Of the dispensed subjects 146 completed the study and 4 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Senofilcon C Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study. | 75 |
| Comfilcon A Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study. | 75 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Torn Lens | 0 | 1 |
| Overall Study | Unsatisfactory Lens Fitting | 0 | 1 |
| Overall Study | Visit 5 assessments not completed | 0 | 1 |
Baseline characteristics
| Characteristic | Comfilcon A | Total | Senofilcon C |
|---|---|---|---|
| Age, Continuous | 30.2 Years STANDARD_DEVIATION 5.62 | 29.2 Years STANDARD_DEVIATION 5.91 | 28.2 Years STANDARD_DEVIATION 6.05 |
| Race/Ethnicity, Customized Asian | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants | 19 Participants | 12 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 65 Participants | 126 Participants | 61 Participants |
| Region of Enrollment North America | 75 Participants | 150 Participants | 75 Participants |
| Sex: Female, Male Female | 61 Participants | 116 Participants | 55 Participants |
| Sex: Female, Male Male | 14 Participants | 34 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 75 | 0 / 75 |
| serious Total, serious adverse events | 0 / 75 | 0 / 75 |
Outcome results
Primary
Acceptable Lens Fitting
Lens fit was assessed and recorded for each subject and eye at post lens fitting, 1-, 2-, 3- and 4- week follow-up evaluations. Lens fit was a binary response acceptable and unacceptable lens fit. The proportion of eyes with acceptable lens fitting at post lens fit and across all four follow-ups was combined and reported.
Time frame: Up to 4 Week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon C | Acceptable Lens Fitting | 1 Proportion of eyes |
| Comfilcon A | Acceptable Lens Fitting | 0.99 Proportion of eyes |
Primary
Overall Comfort
Clue 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. CLUE Comfort was assessed at 1-, 2-, 3 and 4- week Follow-up evaluations. The average CLUE comfort score for each lens was reported for each visit.
Time frame: Up to 4 Week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Senofilcon C | Overall Comfort | 1-Week Follow-up | 71.75 Units on a scale | Standard Deviation 22.193 |
| Senofilcon C | Overall Comfort | 2-Week Follow-up | 70.58 Units on a scale | Standard Deviation 22.5 |
| Senofilcon C | Overall Comfort | 4-Week Follow-up | 68.25 Units on a scale | Standard Deviation 27.137 |
| Senofilcon C | Overall Comfort | 3-Week Follow-up | 68.75 Units on a scale | Standard Deviation 26.108 |
| Comfilcon A | Overall Comfort | 3-Week Follow-up | 53.43 Units on a scale | Standard Deviation 29.912 |
| Comfilcon A | Overall Comfort | 1-Week Follow-up | 56.68 Units on a scale | Standard Deviation 27.747 |
| Comfilcon A | Overall Comfort | 4-Week Follow-up | 54.57 Units on a scale | Standard Deviation 30.522 |
| Comfilcon A | Overall Comfort | 2-Week Follow-up | 54.69 Units on a scale | Standard Deviation 30.268 |