Contact Lenses, Myopia
Conditions
Brief summary
The objective of the study is to evaluate the product performance of visual acuity of the Bausch + Lomb investigational daily disposable contact lenses compared to the currently marketed Johnson & Johnson Acuvue Moist contact lenses.
Interventions
DEVICEBausch & Lomb new daily disposable
Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.
DEVICEJohnson & Johnson Acuvue Moist
Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must be adapted soft contact lens wearers that are interested in daily disposable wear or currently adapted daily disposable soft contact lens wearers. * Subjects must agree to wear study lenses on a daily disposable basis for approximately one week and crossover to wear another study lens for one week. * Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye. * Subjects must have clear central corneas that are free of any anterior segment disorders. * Subjects must be myopic and require lens correction from -1.00 D to -6.00 diopters (D) in each eye.
Exclusion criteria
* Subjects who have worn gas permeable contact lenses within the last 30 days or who have worn polymethylmethacrylate lenses within the last 3 months. * Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an affect 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 who are not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses. * Subjects who currently wear monovision, multifocal, or toric contact lenses. * Subjects with an ocular astigmatism of 1.00 D or greater in either eye. * Subjects with anisometropia (spherical equivalent) of greater than 1.00 D. * Subjects with any grade 2 or greater finding during the slit lamp examination (refer to Appendix B for methods of clinical evaluation). * Subjects with corneal infiltrates, of ANY GRADE, are not eligible. * Subjects with any Present finding during the slit lamp examination (refer to Appendix B for methods of clinical evaluation) that, in the Investigator's judgment, interferes with contact lens wear. * Subjects with any scar or neovascularization within the central 4 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study. * Subjects who are aphakic. * Subjects who are amblyopic. * Subjects who have presbyopia. * Subjects who have had any corneal surgery (eg, refractive surgery). * Subjects who are allergic to any component in the study care products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | Dispensing Visit and 1 week follow-up | Distance High contrast logMAR visual acuity (VA), difference between the test and control lens at dispensing visit and 1 week follow-up, crossover visit and 1 week follow-up. |
| Slit Lamp Examination > Grade 2 | All study visits from screening through 2 week follow-up | Slit lamp findings for each eye will be assessed at each study visit, including epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Slit lamp \> 2. |
Countries
United States
Participant flow
Recruitment details
This was a two week, multicenter, open label, bilateral, crossover study. First Participant was enrolled 08/23/2010 and last participant exited the study 10/08/2010.
Pre-assignment details
102 participants(204 eyes) were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study All eligible subjects | 102 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (1 Week) | Lost to Follow-up | 1 | 1 |
| First Intervention (1 Week) | Unacceptable Distance Visual Acuity | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age Continuous | 28.0 years STANDARD_DEVIATION 7.8 |
| Region of Enrollment United States | 102 participants |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 102 | 0 / 102 |
| serious Total, serious adverse events | 0 / 102 | 0 / 102 |
Outcome results
Primary
Slit Lamp Examination > Grade 2
Slit lamp findings for each eye will be assessed at each study visit, including epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Slit lamp \> 2.
Time frame: All study visits from screening through 2 week follow-up
Population: All Dispensed Eyes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bausch & Lomb New Daily Disposable | Slit Lamp Examination > Grade 2 | 0 Eyes |
| Johnson & Johnson Acuvue Moist | Slit Lamp Examination > Grade 2 | 0 Eyes |
Primary
Visual Acuity
Distance High contrast logMAR visual acuity (VA), difference between the test and control lens at dispensing visit and 1 week follow-up, crossover visit and 1 week follow-up.
Time frame: Dispensing Visit and 1 week follow-up
Population: All Eligible Dispensed Eyes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bausch & Lomb New Daily Disposable | Visual Acuity | Dispensing Visit | -0.056 LogMAR | Standard Deviation 0.079 |
| Bausch & Lomb New Daily Disposable | Visual Acuity | 1 Week Follow-up | -0.063 LogMAR | Standard Deviation 0.079 |
| Johnson & Johnson Acuvue Moist | Visual Acuity | Dispensing Visit | -0.070 LogMAR | Standard Deviation 0.066 |
| Johnson & Johnson Acuvue Moist | Visual Acuity | 1 Week Follow-up | -0.065 LogMAR | Standard Deviation 0.079 |