Myopia
Conditions
Keywords
contact lens
Brief summary
The objective of this one week, single group, bilateral, open-label study is to evaluate the product performance of the Bausch & Lomb daily disposable cosmetic tint contact lens (Test) when worn on a daily disposable basis by adapted current wearers of a marketed opaque tinted soft contact lens.
Interventions
DEVICEDaily disposable cosmetic tint lens
Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 38 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be females of Chinese descent and of legal age and no older than 38. OR subjects that are females of Chinese descent and are at least 15 years of age and less than the legal age must: have a parent/legal guardian provide informed consent. * Subjects must have clear central corneas and be free of any anterior segment disorders. * Subjects must be adapted current wearers of marketed opaque tinted soft contact lenses, wear their lenses two days or more per week, and wear a lens in each eye.
Exclusion criteria
* Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or have worn polymethylmethacrylate (PMMA) lenses within the last three months. * Subjects who have 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 with an active ocular disease or are using any ocular medication. * Subjects with any scar or neovascularization within the central 4 mm of the cornea. * Subjects who are aphakic or amblyopic. * Subjects who have had any corneal surgery (eg, refractive surgery). * Subjects who currently wear monovision, multifocal, or toric contact lenses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Market Research Survey | 1 week | Online subjective assessments that subjects responded to after wearing the study lenses for at least one week. Subjects were asked to rate their overall opinion as: Excellent, Very Good, Good, Fair, or Poor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Evaluation - Centration | Over all study visits through 1 week | To determine proper lens parameters the lens relationship to the eye was observed using a slit lamp. Lens centration, meaning the lens should provide full corneal coverage, was assessed during the slit lamp evaluation. Findings were reported as: Excellent, Good, Fair, or Poor. |
| Lens Evaluation - Movement | Over all study visits through 1 week | To determine proper lens parameters the lens relationship to the eye was observed using a slit lamp. Lens movement, meaning the lens should provide discernible movement with: * Primary gaze blink * Upgaze blink * Upgaze lag was assessed during the slit lamp evaluation. Findings were reported as: Adequate, Excessive, Insufficient, Adherence. |
| Visual Acuity - Distance High Contrast logMAR (Logarithm of the Minimum Angle of Resolution) Lens Visual Acuity (VA). | Over all study visits for 1 week | For determination of high contrast VA, the subject was to be seated so that the distance from the subject's eyes to the logMAR chart is 6.5 feet (2.0 meters). The chart should be at eye level for the subject. The logMAR charts have two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity should be measured through the phoropter using the distance refractive correction with the addition of +0.50D to compensate for the reduced test distance of 6.5 feet (2.0 meters). |
Countries
Singapore
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prism I Bausch & Lomb daily disposable cosmetic tint contact lens
Daily disposable cosmetic tint lens: Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week. | 212 |
| Total | 212 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Inability to maintain visit schedule | 1 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Prism I |
|---|---|
| Age, Continuous | 25.0 years STANDARD_DEVIATION 5.2 |
| Sex: Female, Male Female | 212 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 212 |
| serious Total, serious adverse events | 0 / 212 |
Outcome results
Primary
Market Research Survey
Online subjective assessments that subjects responded to after wearing the study lenses for at least one week. Subjects were asked to rate their overall opinion as: Excellent, Very Good, Good, Fair, or Poor.
Time frame: 1 week
Population: Subjects who completed the survey.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prism I | Market Research Survey | Excellent | 10 Participants |
| Prism I | Market Research Survey | Very Good | 91 Participants |
| Prism I | Market Research Survey | Good | 93 Participants |
| Prism I | Market Research Survey | Fair | 16 Participants |
| Prism I | Market Research Survey | Poor | 0 Participants |
Secondary
Lens Evaluation - Centration
To determine proper lens parameters the lens relationship to the eye was observed using a slit lamp. Lens centration, meaning the lens should provide full corneal coverage, was assessed during the slit lamp evaluation. Findings were reported as: Excellent, Good, Fair, or Poor.
Time frame: Over all study visits through 1 week
Population: Eligible, dispense eyes with non-missing scores.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Prism I | Lens Evaluation - Centration | Excellent | 287 eyes |
| Prism I | Lens Evaluation - Centration | Good | 109 eyes |
| Prism I | Lens Evaluation - Centration | Fair | 14 eyes |
| Prism I | Lens Evaluation - Centration | Poor | 14 eyes |
Secondary
Lens Evaluation - Movement
To determine proper lens parameters the lens relationship to the eye was observed using a slit lamp. Lens movement, meaning the lens should provide discernible movement with: * Primary gaze blink * Upgaze blink * Upgaze lag was assessed during the slit lamp evaluation. Findings were reported as: Adequate, Excessive, Insufficient, Adherence.
Time frame: Over all study visits through 1 week
Population: Eligible, dispense eyes with non-missing scores.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Prism I | Lens Evaluation - Movement | Excessive | 0 eyes |
| Prism I | Lens Evaluation - Movement | Adequate | 246 eyes |
| Prism I | Lens Evaluation - Movement | Insufficient | 168 eyes |
| Prism I | Lens Evaluation - Movement | Adherence | 10 eyes |
Secondary
Visual Acuity - Distance High Contrast logMAR (Logarithm of the Minimum Angle of Resolution) Lens Visual Acuity (VA).
For determination of high contrast VA, the subject was to be seated so that the distance from the subject's eyes to the logMAR chart is 6.5 feet (2.0 meters). The chart should be at eye level for the subject. The logMAR charts have two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity should be measured through the phoropter using the distance refractive correction with the addition of +0.50D to compensate for the reduced test distance of 6.5 feet (2.0 meters).
Time frame: Over all study visits for 1 week
Population: Eyes with VA results
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prism I | Visual Acuity - Distance High Contrast logMAR (Logarithm of the Minimum Angle of Resolution) Lens Visual Acuity (VA). | 0.012 logMAR | Standard Error 0.07 |