Visual Acuity
Conditions
Brief summary
Approximately 120 subjects will be comparing two soft contact lenses for one week each.
Interventions
DEVICEsenofilcon A
Subjects will wear the contact lenses in both eyes for seven days
DEVICEdelefilcon A
Subjects will wear the contact lenses in both eyes for seven days
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, and sign the Statement of Informed Consent, and receive a fully executed copy of the form. 2. The subject must be appear able and willing to adhere to instruction set forth in this clinical protocol. 3. The subject be between (and including) 18 and 39 years of age. 4. The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day worn for at least 30 days immediately preceding the study. 5. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 to -6.00 D in each eye. 6. The subject must have best corrected visual acuity of 20/25 or better in each eye.
Exclusion criteria
1. Currently pregnant or breastfeeding (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 autoimmune disease or use of any medication, which may interfere with contact lens wear. 4. Entropoin, Ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia. 5. Any previous, or planned ocular or intraocular 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 inflammatory event (e.g. past peripheral ulcer or round scar), or any other ocular abnormality that may contraindicate contact lens wear. 7. Any ocular infection. 8. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 9. Monovision, multifocal, toric, or extended wear contact lens correction. 10. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. 11. History of binocular vision abnormality or strabismus. 12. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV) by self-report.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Overall Comfort | 1-week Follow-up | 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 Vision | 1-week Follow-up | Subjective Overall Vision was evaluated using the Contact Lens User Experience Vison 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
United States
Participant flow
Pre-assignment details
A total of 120 subjects were enrolled into this study. All enrolled subjects were dispensed a study lens. Of the dispensed subjects 1 was discontinued from the study and 119 subjects completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Senofilcon A / Delefilcon A / Senofilcon A All subjects that randomized to receive this sequence and were dispensed a study lens. | 60 |
| Delefilcon A / Senofilcon A / Delefilcon A All subjects that randomized to receive this sequence and were dispensed a study lens. | 60 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Senofilcon A / Delefilcon A / Senofilcon A | Total | Delefilcon A / Senofilcon A / Delefilcon A |
|---|---|---|---|
| Age, Continuous | 28.6 years STANDARD_DEVIATION 6.14 | 28.0 years STANDARD_DEVIATION 5.6 | 27.6 years STANDARD_DEVIATION 4.97 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 14 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 47 Participants | 99 Participants | 52 Participants |
| Region of Enrollment United States | 60 participants | 120 participants | 60 participants |
| Sex: Female, Male Female | 42 Participants | 80 Participants | 38 Participants |
| Sex: Female, Male Male | 18 Participants | 40 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 120 | 0 / 120 |
| serious Total, serious adverse events | 0 / 120 | 0 / 120 |
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: 1-week Follow-up
Population: The Analysis population includes subjects that completed all study visits without a major protocol deviation. Due to the study design the number of observations analyzed is larger than the number of participants. This is due to the fact that some subjects wore senofilcon A twice while some subjects wore delefilcon A twice (see Participant Flow).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Subjective Overall Comfort | 75.5 units on a scale | Standard Deviation 28.12 |
| Delefilcon A | Subjective Overall Comfort | 70.8 units on a scale | Standard Deviation 28.6 |
Primary
Subjective Overall Vision
Subjective Overall Vision was evaluated using the Contact Lens User Experience Vison 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: 1-week Follow-up
Population: The Analysis population includes subjects that completed all study visits without a major protocol deviation. Due to the study design the number of observations analyzed is larger than the number of participants. This is due to the fact that some subjects wore senofilcon A twice while some subjects wore delefilcon A twice (see Participant Flow).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon A | Subjective Overall Vision | 75.3 units on a scale | Standard Deviation 22.04 |
| Delefilcon A | Subjective Overall Vision | 72.1 units on a scale | Standard Deviation 24.05 |