Myopia
Conditions
Brief summary
Evaluation of Johnson & Johnson Acuvue Vita (senofilcon C) soft contact lenses to the Bausch + Lomb Ultra (samfilcon A) soft contact lenses
Detailed description
to compare the performance of currently marketed Johnson & Johnson Acuvue Vita (senofilcon C) soft contact lenses to the currently marketed Bausch + Lomb Ultra (samfilcon A) soft contact lenses among adapted wearers of Acuvue Oasys soft contact lenses.
Interventions
DEVICESenofilcon C
Senofilcon C Contact Lens
DEVICESamfilcon A
Samfilcon A Contact Lens
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
randomized, bilateral, d o u b l e - masked, 1-month study with two parallel groups
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subjects must be between the ages of 18 and 40 years old, inclusive, on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent. 2. Subjects must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations. 3. Subjects must be willing and able to comply with all treatment and follow-up/study procedures. 4. Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye. 5. Subjects must have clear central corneas and be free of any anterior segment disorders. 6. Subjects must be myopic and require contact lens sphere power correction from -0.50 diopter (D) to -6.00 D (considering vertex distance adjustments in both eyes). 7. Subjects must be habitual wearers of Johnson & Johnson Acuvue Oasys single vision spherical soft contact lenses in each eye. 8. Subjects must use a contact lens care regimen on a routine basis. 9. Subjects must agree to wear their study lenses on a daily wear basis for the duration
Exclusion criteria
1. Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation 2. Subjects who are women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions: * she is currently pregnant * she plans to become pregnant during the study * she is breastfeeding 3. Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study. 4. Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| End of Day Comfort | 1 month | The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated greater comfort. |
| Overall Vision | 1 month | The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated better overall vision. |
Countries
United States
Participant flow
Recruitment details
There were 271 participants enrolled, with 136 Senofilcon C participants dispensed lenses and 132 Samfilcon A participants dispensed lenses (268 participants total).
Participants by arm
| Arm | Count |
|---|---|
| Senofilcon C Senofilcon C Contact Lens
Senofilcon C: Senofilcon C Contact Lens | 115 |
| Samfilcon A Samfilcon A Contact Lens
Samfilcon A: Samfilcon A Contact Lens | 106 |
| Total | 221 |
Baseline characteristics
| Characteristic | Samfilcon A | Total | Senofilcon C |
|---|---|---|---|
| Age, Continuous | 30.4 years STANDARD_DEVIATION 5.72 | 30.45 years STANDARD_DEVIATION 5.58 | 30.5 years STANDARD_DEVIATION 5.62 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 19 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 90 Participants | 188 Participants | 98 Participants |
| Sex: Female, Male Female | 68 Participants | 139 Participants | 71 Participants |
| Sex: Female, Male Male | 38 Participants | 82 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 136 | 0 / 132 |
| other Total, other adverse events | 0 / 136 | 1 / 132 |
| serious Total, serious adverse events | 0 / 136 | 0 / 132 |
Outcome results
Primary
End of Day Comfort
The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated greater comfort.
Time frame: 1 month
Population: All participants that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Senofilcon C | End of Day Comfort | 80 score on a scale | Standard Deviation 18.15 |
| Samfilcon A | End of Day Comfort | 80 score on a scale | Standard Deviation 20.46 |
Primary
Overall Vision
The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated better overall vision.
Time frame: 1 month
Population: All participants that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Senofilcon C | Overall Vision | 95 score on a scale | Standard Deviation 9.68 |
| Samfilcon A | Overall Vision | 95 score on a scale | Standard Deviation 12.15 |