Myopia
Conditions
Brief summary
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of two RD2135-01 investigational soft contact lenses (Test 1 and Test 2) developed by Bausch + Lomb. The Test lenses will be compared to both Bausch + Lomb PureVision®2 HD (high definition) soft contact lenses and Ciba Vision Air Optix Aqua soft contact lenses when used among currently adapted soft contact lens wearers.
Interventions
DEVICEB&L RD2135-01 lens C
Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
DEVICEB&L RD2135-01 lens D
Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
DEVICEPureVision2
Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
DEVICEAir Optix Aqua
Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. * Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand. * Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye. * Be myopic and require lens correction from -0.50 diopters (D) to -6.00 D in each eye. * Must agree to wear the study lenses on a daily wear basis for the duration of the study. * Must be willing to use a lens care system on a regular basis. * If the subject requires a Washout Period, the subject must be willing to discontinue contact lens wear and be willing to wear either spectacles or no lenses during this Washout Period.
Exclusion criteria
* Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses. * Have an active ocular disease, any corneal infiltrative response or are using any ocular medications. * Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months. * Any scar or neovascularization within the central 4mm of the cornea. * Any Grade 2 or greater finding during the slit lamp examination, Subjects with corneal infiltrates, of ANY GRADE, are not eligible. * Any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. * Anisometropia (spherical equivalent) of greater than 2.00 D. * Any systemic disease affecting ocular health. * Using any systemic or topical medications that will affect ocular physiology or lens performance. * Aphakic. * Amblyopic. * Allergic to any component in the study products. * Have had any corneal surgery (ie, refractive surgery). * Currently wear monovision correction, multifocal, or toric contact lenses. * Ocular astigmatism greater than 1.00 D in either eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | At 1 week follow up | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms and Complaints | At 1 Week follow up | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded for each eye based on the participant's experience with their study lenses worn for that respective treatment period. Symptoms/complaints parameters included the following: Burning/stinging upon insertion, Comfort upon insertion, Overall comfort, Comfort at end of day, Ease of handling/insertion, Ease of handling/removal, Dryness, Itchiness, Redness, Vision upon insertion, Vision, Vision in low light, Lens cleanness upon insertion, Lens cleanness upon removal, Lens cleanness, Dryness at end of day, and Overall impression. |
Countries
United States
Participant flow
Recruitment details
This was a randomized, bilateral, study, with a crossover at one week and a second crossover at two weeks. A total of 216 subjects (432 eyes) were enrolled in this study. Participants were randomized to receive either, the Test Lens C, Test Lens D and PureVision2 lenses, or the Test Lens C, Test Lens D and Air Optix Aqua lenses.
Participants by arm
| Arm | Count |
|---|---|
| B&L RD2135-01 Lens C Then B&L RD2135-01 Lens D Then PureVision B&L RD2135-01 Lens C for one week then B&L RD2135-01 Lens D for one week then PureVision2 for one week | 105 |
| B&L RD2135-01 Lens C Then B&L RD2135-01 Lens D Then Ciba Vis B&L RD2135-01 Lens C for one week then B&L RD2135-01 Lens D for one week then Ciba Vision for one week | 105 |
| Total | 210 |
Baseline characteristics
| Characteristic | B&L RD2135-01 Lens C Then B&L RD2135-01 Lens D Then PureVision | B&L RD2135-01 Lens C Then B&L RD2135-01 Lens D Then Ciba Vis | Total |
|---|---|---|---|
| Age, Continuous | 31.3 years STANDARD_DEVIATION 8.55 | 31.8 years STANDARD_DEVIATION 8.68 | 31.5 years STANDARD_DEVIATION 8.6 |
| Sex: Female, Male Female | 72 Participants | 71 Participants | 143 Participants |
| Sex: Female, Male Male | 33 Participants | 34 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 212 | 0 / 212 | 0 / 106 | 0 / 106 |
| serious Total, serious adverse events | 0 / 212 | 0 / 212 | 0 / 106 | 0 / 106 |
Outcome results
Primary
Visual Acuity
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Time frame: At 1 week follow up
Population: There were 212 eligible, dispensed participants (424 eyes). Participants/eyes received multiple treatment groups in this cross-over study. All eyes received investigational lens C and investigation lens D. Half of the eyes received PureVision2 and half of the eyes received Ciba Vision Air Optix Aqua.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| B&L RD2135-01 Lens C | Visual Acuity | -0.089 logMAR | Standard Deviation 0.078 |
| B&L RD2135-01 Lens D | Visual Acuity | -0.087 logMAR | Standard Deviation 0.079 |
| PureVision2 | Visual Acuity | -0.086 logMAR | Standard Deviation 0.077 |
| Ciba Vision Air Optix Aqua | Visual Acuity | -0.086 logMAR | Standard Deviation 0.082 |
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 for each eye based on the participant's experience with their study lenses worn for that respective treatment period. Symptoms/complaints parameters included the following: Burning/stinging upon insertion, Comfort upon insertion, Overall comfort, Comfort at end of day, Ease of handling/insertion, Ease of handling/removal, Dryness, Itchiness, Redness, Vision upon insertion, Vision, Vision in low light, Lens cleanness upon insertion, Lens cleanness upon removal, Lens cleanness, Dryness at end of day, and Overall impression.
Time frame: At 1 Week follow up
Population: There were 212 eligible, dispensed participants (424 eyes). Participants/eyes received multiple treatment groups in this cross-over study. All eyes received investigational lens C and investigation lens D. Half of the eyes received PureVision2 and half of the eyes received Ciba Vision Air Optix Aqua.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| B&L RD2135-01 Lens C | Symptoms and Complaints | Redness | 92.4 score on a scale | Standard Deviation 11.7 |
| B&L RD2135-01 Lens C | Symptoms and Complaints | Overall comfort | 88.0 score on a scale | Standard Deviation 14.6 |
| B&L RD2135-01 Lens C | Symptoms and Complaints | Vision upon insertion | 93.4 score on a scale | Standard Deviation 9.6 |
| B&L RD2135-01 Lens C | Symptoms and Complaints | Burning/stinging upon insertion | 91.3 score on a scale | Standard Deviation 13.1 |
| B&L RD2135-01 Lens C | Symptoms and Complaints | Vision | 92.3 score on a scale | Standard Deviation 11.4 |
| B&L RD2135-01 Lens C | Symptoms and Complaints | Overall impression | 84.5 score on a scale | Standard Deviation 17 |
| B&L RD2135-01 Lens C | Symptoms and Complaints | Lens cleanness | 91.8 score on a scale | Standard Deviation 10.6 |
| B&L RD2135-01 Lens C | Symptoms and Complaints | Vision in low light | 91.0 score on a scale | Standard Deviation 11.9 |
| B&L RD2135-01 Lens C | Symptoms and Complaints | Lens cleanness upon insertion | 93.1 score on a scale | Standard Deviation 10.9 |
| B&L RD2135-01 Lens C | Symptoms and Complaints | Comfort at end of day | 81.2 score on a scale | Standard Deviation 18.9 |
| B&L RD2135-01 Lens C | Symptoms and Complaints | Ease of handling/insertion | 89.5 score on a scale | Standard Deviation 16.6 |
| B&L RD2135-01 Lens C | Symptoms and Complaints | Comfort upon insertion | 89.6 score on a scale | Standard Deviation 14.5 |
| B&L RD2135-01 Lens C | Symptoms and Complaints | Ease of handling/removal | 91.1 score on a scale | Standard Deviation 14.3 |
| B&L RD2135-01 Lens C | Symptoms and Complaints | Dryness | 84.4 score on a scale | Standard Deviation 16.1 |
| B&L RD2135-01 Lens C | Symptoms and Complaints | Lens cleannes upon removal | 89.9 score on a scale | Standard Deviation 12.2 |
| B&L RD2135-01 Lens C | Symptoms and Complaints | Dryness at end of day | 82.4 score on a scale | Standard Deviation 17.7 |
| B&L RD2135-01 Lens C | Symptoms and Complaints | Itchiness | 90.6 score on a scale | Standard Deviation 12.9 |
| B&L RD2135-01 Lens D | Symptoms and Complaints | Dryness at end of day | 80.3 score on a scale | Standard Deviation 19.3 |
| B&L RD2135-01 Lens D | Symptoms and Complaints | Comfort at end of day | 79.3 score on a scale | Standard Deviation 20.2 |
| B&L RD2135-01 Lens D | Symptoms and Complaints | Ease of handling/insertion | 88.6 score on a scale | Standard Deviation 17.3 |
| B&L RD2135-01 Lens D | Symptoms and Complaints | Lens cleanness | 91.2 score on a scale | Standard Deviation 11.7 |
| B&L RD2135-01 Lens D | Symptoms and Complaints | Vision upon insertion | 91.5 score on a scale | Standard Deviation 13.3 |
| B&L RD2135-01 Lens D | Symptoms and Complaints | Burning/stinging upon insertion | 91.3 score on a scale | Standard Deviation 12.4 |
| B&L RD2135-01 Lens D | Symptoms and Complaints | Overall comfort | 85.7 score on a scale | Standard Deviation 16.9 |
| B&L RD2135-01 Lens D | Symptoms and Complaints | Redness | 91.6 score on a scale | Standard Deviation 13.1 |
| B&L RD2135-01 Lens D | Symptoms and Complaints | Vision | 91.9 score on a scale | Standard Deviation 13.1 |
| B&L RD2135-01 Lens D | Symptoms and Complaints | Ease of handling/removal | 91.0 score on a scale | Standard Deviation 13.6 |
| B&L RD2135-01 Lens D | Symptoms and Complaints | Overall impression | 82.2 score on a scale | Standard Deviation 19 |
| B&L RD2135-01 Lens D | Symptoms and Complaints | Vision in low light | 89.9 score on a scale | Standard Deviation 13.4 |
| B&L RD2135-01 Lens D | Symptoms and Complaints | Lens cleannes upon removal | 89.3 score on a scale | Standard Deviation 12.9 |
| B&L RD2135-01 Lens D | Symptoms and Complaints | Comfort upon insertion | 88.2 score on a scale | Standard Deviation 15.6 |
| B&L RD2135-01 Lens D | Symptoms and Complaints | Itchiness | 89.6 score on a scale | Standard Deviation 15.9 |
| B&L RD2135-01 Lens D | Symptoms and Complaints | Lens cleanness upon insertion | 92.8 score on a scale | Standard Deviation 11.4 |
| B&L RD2135-01 Lens D | Symptoms and Complaints | Dryness | 81.9 score on a scale | Standard Deviation 18.1 |
| PureVision2 | Symptoms and Complaints | Lens cleanness upon insertion | 89.7 score on a scale | Standard Deviation 14.6 |
| PureVision2 | Symptoms and Complaints | Lens cleannes upon removal | 86.3 score on a scale | Standard Deviation 17.2 |
| PureVision2 | Symptoms and Complaints | Lens cleanness | 86.6 score on a scale | Standard Deviation 17 |
| PureVision2 | Symptoms and Complaints | Comfort at end of day | 72.0 score on a scale | Standard Deviation 22.9 |
| PureVision2 | Symptoms and Complaints | Dryness at end of day | 75.5 score on a scale | Standard Deviation 21.7 |
| PureVision2 | Symptoms and Complaints | Overall impression | 73.7 score on a scale | Standard Deviation 24.6 |
| PureVision2 | Symptoms and Complaints | Ease of handling/insertion | 85.0 score on a scale | Standard Deviation 20.4 |
| PureVision2 | Symptoms and Complaints | Ease of handling/removal | 89.4 score on a scale | Standard Deviation 15.6 |
| PureVision2 | Symptoms and Complaints | Dryness | 77.0 score on a scale | Standard Deviation 21.6 |
| PureVision2 | Symptoms and Complaints | Comfort upon insertion | 78.7 score on a scale | Standard Deviation 15.6 |
| PureVision2 | Symptoms and Complaints | Itchiness | 87.4 score on a scale | Standard Deviation 17 |
| PureVision2 | Symptoms and Complaints | Redness | 90.6 score on a scale | Standard Deviation 14 |
| PureVision2 | Symptoms and Complaints | Vision upon insertion | 87.0 score on a scale | Standard Deviation 17.5 |
| PureVision2 | Symptoms and Complaints | Vision | 88.1 score on a scale | Standard Deviation 14.6 |
| PureVision2 | Symptoms and Complaints | Overall comfort | 78.4 score on a scale | Standard Deviation 20.4 |
| PureVision2 | Symptoms and Complaints | Vision in low light | 87.3 score on a scale | Standard Deviation 13.8 |
| PureVision2 | Symptoms and Complaints | Burning/stinging upon insertion | 83.1 score on a scale | Standard Deviation 21.4 |
| Ciba Vision Air Optix Aqua | Symptoms and Complaints | Overall impression | 83.9 score on a scale | Standard Deviation 18.3 |
| Ciba Vision Air Optix Aqua | Symptoms and Complaints | Burning/stinging upon insertion | 92.6 score on a scale | Standard Deviation 9.9 |
| Ciba Vision Air Optix Aqua | Symptoms and Complaints | Comfort upon insertion | 89.6 score on a scale | Standard Deviation 12 |
| Ciba Vision Air Optix Aqua | Symptoms and Complaints | Overall comfort | 86.6 score on a scale | Standard Deviation 15.8 |
| Ciba Vision Air Optix Aqua | Symptoms and Complaints | Comfort at end of day | 79.7 score on a scale | Standard Deviation 19.7 |
| Ciba Vision Air Optix Aqua | Symptoms and Complaints | Ease of handling/insertion | 89.0 score on a scale | Standard Deviation 15.3 |
| Ciba Vision Air Optix Aqua | Symptoms and Complaints | Ease of handling/removal | 89.4 score on a scale | Standard Deviation 15.5 |
| Ciba Vision Air Optix Aqua | Symptoms and Complaints | Dryness | 84.4 score on a scale | Standard Deviation 17.3 |
| Ciba Vision Air Optix Aqua | Symptoms and Complaints | Itchiness | 88.5 score on a scale | Standard Deviation 17.3 |
| Ciba Vision Air Optix Aqua | Symptoms and Complaints | Redness | 91.2 score on a scale | Standard Deviation 12.5 |
| Ciba Vision Air Optix Aqua | Symptoms and Complaints | Vision upon insertion | 93.1 score on a scale | Standard Deviation 9.6 |
| Ciba Vision Air Optix Aqua | Symptoms and Complaints | Vision | 93.5 score on a scale | Standard Deviation 10.3 |
| Ciba Vision Air Optix Aqua | Symptoms and Complaints | Vision in low light | 91.4 score on a scale | Standard Deviation 12.5 |
| Ciba Vision Air Optix Aqua | Symptoms and Complaints | Lens cleanness upon insertion | 94.4 score on a scale | Standard Deviation 7.7 |
| Ciba Vision Air Optix Aqua | Symptoms and Complaints | Lens cleannes upon removal | 90.9 score on a scale | Standard Deviation 9.7 |
| Ciba Vision Air Optix Aqua | Symptoms and Complaints | Lens cleanness | 92.5 score on a scale | Standard Deviation 9.1 |
| Ciba Vision Air Optix Aqua | Symptoms and Complaints | Dryness at end of day | 82.4 score on a scale | Standard Deviation 17.3 |