Visual Acuity
Conditions
Brief summary
The primary objective of this study is to evaluate the clinical performance of two marketed silicone hydrogel contact lenses in an Indian population in the following areas: physiological characteristics, comfort characteristics and vision characteristics.
Interventions
DEVICEsenofilcon A
One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day
DEVICElotrafilcon B
One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject must read, understand English, and sign the Statement of Informed Consent and receive a fully executed copy of the form. 2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. The subject must be 18 and less than 40 years of age. 4. The subject's corrected spherical equivalent distance refraction must be in the range of -1.00 to -5.00D in each eye with visual acuity of 20/25 provided study lenses in each eye. 5. The subject must have less than -1.00 D of cylindrical refraction. 6. The subject must have best corrected visual acuity of 20/25 or better in each eye. 7. The subject must be an adapted soft contact lens wearer in both eyes. 8. The subject must have normal eyes.
Exclusion criteria
1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued) 2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear. 3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. 4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia. 5. Any previous, or planned ocular or interocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.). 6. 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. 7. Any ocular infections 8. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 9. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment 10. History of binocular vision abnormality or strabismus. 11. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self report. 12. Employee of the investigational clinic (e.g. investigator, Coordinator, Technician)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Overall Comfort | 11 days Post fit | Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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 Quality of Vision | 11 days post fit | Subjective Overall quality of Vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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
India
Participant flow
Pre-assignment details
A total of 54 subjects were enrolled in this study. Of the enrolled subjects all 54 were dispensed a study lens. Of the dispensed 52 completed the study while 2 were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Dispensed Subjects All subjects that were dispensed at least one study lens throughout the duration of the study. | 54 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Unsatisfactory lens fitting | 0 | 1 |
| Period 2 | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Dispensed Subjects |
|---|---|
| Age, Continuous | 25.83 years STANDARD_DEVIATION 4.621 |
| Race/Ethnicity, Customized Asian | 54 participants |
| Region of Enrollment India | 54 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 54 | 0 / 54 |
| serious Total, serious adverse events | 0 / 54 | 0 / 54 |
Outcome results
Primary
Subjective Overall Comfort
Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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: 11 days Post fit
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Subjective Overall Comfort | 58.65 units on a scale | Standard Deviation 18.685 |
| Lotrafilcon B | Subjective Overall Comfort | 59.44 units on a scale | Standard Deviation 16.458 |
Primary
Subjective Overall Quality of Vision
Subjective Overall quality of Vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). 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: 11 days post fit
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Subjective Overall Quality of Vision | 55.60 units on a scale | Standard Deviation 16.49 |
| Lotrafilcon B | Subjective Overall Quality of Vision | 58.71 units on a scale | Standard Deviation 14.035 |