Myopia
Conditions
Brief summary
The objective of the study is to evaluate the product performance of the Bausch + Lomb toric investigational contact lenses compared to the currently marketed PureVision toric contact lenses.
Interventions
DEVICEInvestigational Toric Lens
Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.
DEVICEPureVision Toric Lens
Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects must have clear central corneas and be free of any anterior segment disorders. * Subjects must be adapted lens wearers, wear a lens in each eye and each lens must be of the same manufacture and brand. * Subjects must be myopic and require lens correction * Subjects must be habitual wearers of toric soft contact lenses.
Exclusion criteria
* 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. * 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 who are using any ocular medication. * Subjects with any grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates, of ANY GRADE, are not eligible. * Subjects with any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. * Subjects who are allergic to any component in the study care products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees. | 2 weeks | — |
| Visual Acuity | 2 weeks | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms and Complaints | 2 weeks | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded at each post-dispensing visit based on the subject's experience with the study lens worn prior to the visit. The symptoms/complaints parameters were: Burning/stinging upon insertion; Comfort upon insertion, Overall comfort, and Comfort at the end of the day; Ease of handling/insertion, and Ease of handling/removal; Dryness; Itchiness; Redness; Vision; Lens cleanliness; and Overall impression. |
| Percentage of Eyes With > Grade 2 Slit Lamp Findings | 2 weeks | Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding \> grade 2, across abnormalities. |
Countries
United States
Participant flow
Recruitment details
A total of 151 participants (302 eyes) were randomized to receive test contact lenses and 151 participants (302 eyes) were randomized to receive control contact lenses. After two weeks of wearing the first lens type, the participants crossed over to the second lens type for two weeks.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants were randomized 1:1 to receive test contact lenses or control contact lenses. After two weeks of wearing the first lens type, the participants crossed over to the second lens type for two weeks. | 302 |
| Total | 302 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 34.9 years STANDARD_DEVIATION 11.1 |
| Sex: Female, Male Female | 208 Participants |
| Sex: Female, Male Male | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 151 | 0 / 151 |
| serious Total, serious adverse events | 0 / 151 | 0 / 151 |
Outcome results
Primary
Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees.
Time frame: 2 weeks
Population: There were 518 eyes in each group for this outcome measure.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Investigational Toric Lens | Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees. | 489 eyes |
| PureVision Toric Lens | Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees. | 426 eyes |
Primary
Visual Acuity
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Time frame: 2 weeks
Population: There were 518 eyes in each group for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Investigational Toric Lens | Visual Acuity | -0.025 logMAR | Standard Deviation 0.106 |
| PureVision Toric Lens | Visual Acuity | -0.021 logMAR | Standard Deviation 0.106 |
Secondary
Percentage of Eyes With > Grade 2 Slit Lamp Findings
Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding \> grade 2, across abnormalities.
Time frame: 2 weeks
Population: There were 600 eyes with non-missing scores in both groups for this outcome measure.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Investigational Toric Lens | Percentage of Eyes With > Grade 2 Slit Lamp Findings | 1 eyes |
| PureVision Toric Lens | Percentage of Eyes With > Grade 2 Slit Lamp Findings | 1 eyes |
Secondary
Symptoms and Complaints
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded at each post-dispensing visit based on the subject's experience with the study lens worn prior to the visit. The symptoms/complaints parameters were: Burning/stinging upon insertion; Comfort upon insertion, Overall comfort, and Comfort at the end of the day; Ease of handling/insertion, and Ease of handling/removal; Dryness; Itchiness; Redness; Vision; Lens cleanliness; and Overall impression.
Time frame: 2 weeks
Population: There were 571 eyes in each group assess for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Toric Lens | Symptoms and Complaints | Burning/stinging upon insertion | 85.4 score on a scale | Standard Deviation 28.1 |
| Investigational Toric Lens | Symptoms and Complaints | Comfort upon insertion | 77.7 score on a scale | Standard Deviation 29.4 |
| Investigational Toric Lens | Symptoms and Complaints | Overall comfort | 77.3 score on a scale | Standard Deviation 29.6 |
| Investigational Toric Lens | Symptoms and Complaints | Comfort at the end of the day | 67.8 score on a scale | Standard Deviation 33.6 |
| Investigational Toric Lens | Symptoms and Complaints | Ease of handling/insertion | 84.4 score on a scale | Standard Deviation 25.2 |
| Investigational Toric Lens | Symptoms and Complaints | Ease of handling/removal | 87.6 score on a scale | Standard Deviation 23 |
| Investigational Toric Lens | Symptoms and Complaints | Dryness | 73.6 score on a scale | Standard Deviation 32.1 |
| Investigational Toric Lens | Symptoms and Complaints | Itchiness | 86.6 score on a scale | Standard Deviation 26 |
| Investigational Toric Lens | Symptoms and Complaints | Redness | 88.0 score on a scale | Standard Deviation 23.9 |
| Investigational Toric Lens | Symptoms and Complaints | Vision | 82.0 score on a scale | Standard Deviation 28.3 |
| Investigational Toric Lens | Symptoms and Complaints | Lens Cleanliness | 86.1 score on a scale | Standard Deviation 22.1 |
| Investigational Toric Lens | Symptoms and Complaints | Overall impression | 74.4 score on a scale | Standard Deviation 30.3 |
| PureVision Toric Lens | Symptoms and Complaints | Lens Cleanliness | 83.5 score on a scale | Standard Deviation 22.1 |
| PureVision Toric Lens | Symptoms and Complaints | Burning/stinging upon insertion | 82.0 score on a scale | Standard Deviation 28.1 |
| PureVision Toric Lens | Symptoms and Complaints | Dryness | 66.3 score on a scale | Standard Deviation 32.1 |
| PureVision Toric Lens | Symptoms and Complaints | Comfort upon insertion | 74.3 score on a scale | Standard Deviation 29.4 |
| PureVision Toric Lens | Symptoms and Complaints | Vision | 73.9 score on a scale | Standard Deviation 28.3 |
| PureVision Toric Lens | Symptoms and Complaints | Overall comfort | 67.9 score on a scale | Standard Deviation 29.6 |
| PureVision Toric Lens | Symptoms and Complaints | Itchiness | 82.0 score on a scale | Standard Deviation 26 |
| PureVision Toric Lens | Symptoms and Complaints | Comfort at the end of the day | 57.6 score on a scale | Standard Deviation 33.6 |
| PureVision Toric Lens | Symptoms and Complaints | Overall impression | 64.2 score on a scale | Standard Deviation 30.3 |
| PureVision Toric Lens | Symptoms and Complaints | Ease of handling/insertion | 80.9 score on a scale | Standard Deviation 25.2 |
| PureVision Toric Lens | Symptoms and Complaints | Redness | 83.5 score on a scale | Standard Deviation 23.9 |
| PureVision Toric Lens | Symptoms and Complaints | Ease of handling/removal | 83.7 score on a scale | Standard Deviation 23 |