Myopia
Conditions
Brief summary
Evaluation of the clinical performance of a novel Bausch & Lomb daily disposable contact lens when compared to the currently marketed Bausch & Lomb SofLens® daily disposable contact lenses and the currently marketed Johnson and Johnson 1-Day Acuvue Moist contact lenses when worn by adapted soft contact lens wearers on a daily disposable basis.
Interventions
DEVICENovel Bausch & Lomb daily disposable contact lenses
Lenses to be worn and replaced daily for 2 weeks.
DEVICEBausch & Lomb SofLens daily disposable contact lenses.
Lenses to be worn and replaced daily for 2 weeks.
DEVICEJohnson and Johnson 1-Day Acuvue Moist contact lenses
Lenses to be worn and replaced daily for 2 weeks.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects with VA correctable to 0.3 logMAR (driving vision) or better in each eye. * Subjects must have clear central corneas and be free of any anterior segment disorders. * Subjects must be myopic and require lens correction in both eyes.
Exclusion criteria
* Subjects with any systemic disease affecting ocular health. * Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance. * Subjects wearing monovision, multifocal or toric contact lenses. * Subjects with grade 2 or greater slit lamp findings.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey | At dispensing | The initial lens performance survey was administered at the Screening/Dispensing Visit. Scores were captured on a scale from 0 to 100, with 100 being the most favorable score. Favorable responses were defined as scores of 80 or greater. |
Countries
United States
Participant flow
Recruitment details
There were 567 participants enrolled (1134 eyes).
Participants by arm
| Arm | Count |
|---|---|
| Novel Bausch & Lomb Contact Lens Novel Bausch & Lomb daily disposable contact lenses
Novel Bausch & Lomb daily disposable contact lenses: Lenses to be worn and replaced daily for 2 weeks. | 188 |
| SofLens Bausch & Lomb SofLens daily disposable contact lenses
Bausch & Lomb SofLens daily disposable contact lenses.: Lenses to be worn and replaced daily for 2 weeks. | 186 |
| Acuvue Johnson and Johnson 1-Day Acuvue Moist contact lenses
Johnson and Johnson 1-Day Acuvue Moist contact lenses: Lenses to be worn and replaced daily for 2 weeks. | 187 |
| Total | 561 |
Baseline characteristics
| Characteristic | Novel Bausch & Lomb Contact Lens | SofLens | Acuvue | Total |
|---|---|---|---|---|
| Age, Continuous | 32.8 years | 32.5 years | 32.5 years | 32.6 years |
| Sex: Female, Male Female | 147 Participants | 136 Participants | 137 Participants | 420 Participants |
| Sex: Female, Male Male | 41 Participants | 50 Participants | 50 Participants | 141 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 189 | 0 / 188 | 0 / 189 |
| serious Total, serious adverse events | 0 / 189 | 0 / 188 | 0 / 189 |
Outcome results
Primary
Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey
The initial lens performance survey was administered at the Screening/Dispensing Visit. Scores were captured on a scale from 0 to 100, with 100 being the most favorable score. Favorable responses were defined as scores of 80 or greater.
Time frame: At dispensing
Population: Eyes that were dispensed contact lenses are included in the analysis population.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Novel Bausch & Lomb Contact Lens | Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey | Lens handling upon insertion | 340 eyes |
| Novel Bausch & Lomb Contact Lens | Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey | Burning/stinging upon insertion | 363 eyes |
| Novel Bausch & Lomb Contact Lens | Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey | Comfort | 333 eyes |
| Novel Bausch & Lomb Contact Lens | Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey | Vision | 324 eyes |
| SofLens | Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey | Vision | 338 eyes |
| SofLens | Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey | Lens handling upon insertion | 293 eyes |
| SofLens | Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey | Comfort | 289 eyes |
| SofLens | Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey | Burning/stinging upon insertion | 333 eyes |
| Acuvue | Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey | Vision | 363 eyes |
| Acuvue | Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey | Burning/stinging upon insertion | 339 eyes |
| Acuvue | Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey | Comfort | 354 eyes |
| Acuvue | Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey | Lens handling upon insertion | 326 eyes |