Myopia
Conditions
Keywords
Contact lens
Brief summary
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses developed by Bausch + Lomb.
Interventions
DEVICETest lens
Investigational silicone hydrogel contact lens worn on a daily wear basis
DEVICEAir Optix Aqua
Air Optix Aqua contact lens worn on a daily wear basis
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Exclusion criteria
* Have worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months. * Any systemic disease affecting ocular health. * Using any systemic or topical medications that will affect ocular physiology or lens performance. * An active ocular disease, any corneal infiltrative response or are using any ocular medications. * Any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. * Allergic to any component in the study care products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | Dispensing & 1-week follow up | Distance high contrast logMAR lens visual acuity (VA) between the Air Optix Aqua lens and the Test Lens at Dispensing and at 1-Week Follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Slit Lamp Findings | 1 week | Measured on a scale of 0-4 where 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe for edema, microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization and corneal infiltrates. |
| Comfort | 1 Weeks | At 1-Week Follow-up, participants rated lens comfort on a scale of 0 to 100, with 100 being the most favorable score. |
Countries
United States
Participant flow
Recruitment details
This study was a randomized, bilateral, subject-masked, two-week study with a crossover at one week, conducted at three sites in the United States (US). First participant was enrolled on 12/01/2010, last participant exited the study on 12/23/2010.
Pre-assignment details
A total of 66 participants (132 eyes) were enrolled in the study. One-half (33) were randomized to receive the investigational RD2117-01 ID4 contact lens first, and the other half (33) was randomized to receive the Air Optix Aqua contact lens first then crossed over after 1 week. All participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study One-half of the participants (33) were randomized to receive the investigational RD2117-01 ID4 contact lens, and the other half (33) was randomized to receive the Air Optix Aqua contact lens. Both groups wore the lenses on a daily wear basis. After one week of wearing the first lens type, the subjects returned for an exam and crossed over to the second lens type for one week. | 66 |
| Total | 66 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 36.2 years STANDARD_DEVIATION 9.6 |
| Region of Enrollment United States | 66 participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 66 | 0 / 66 |
| serious Total, serious adverse events | 0 / 66 | 0 / 66 |
Outcome results
Primary
Visual Acuity
Distance high contrast logMAR lens visual acuity (VA) between the Air Optix Aqua lens and the Test Lens at Dispensing and at 1-Week Follow-up.
Time frame: Dispensing & 1-week follow up
Population: All Eligible, Dispensed Eyes
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Air Optix Aqua | Visual Acuity | Dispensing | -0.083 logMAR | Standard Deviation 0.071 |
| Air Optix Aqua | Visual Acuity | 1-Week Follow-up | -0.084 logMAR | Standard Deviation 0.077 |
| Test Lens | Visual Acuity | Dispensing | -0.085 logMAR | Standard Deviation 0.071 |
| Test Lens | Visual Acuity | 1-Week Follow-up | -0.078 logMAR | Standard Deviation 0.077 |
Secondary
Comfort
At 1-Week Follow-up, participants rated lens comfort on a scale of 0 to 100, with 100 being the most favorable score.
Time frame: 1 Weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Air Optix Aqua | Comfort | 85.5 units on a scale | Standard Deviation 19.5 |
| Test Lens | Comfort | 81.8 units on a scale | Standard Deviation 19.5 |
Secondary
Slit Lamp Findings
Measured on a scale of 0-4 where 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe for edema, microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization and corneal infiltrates.
Time frame: 1 week
Population: All Dispensed Eyes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Air Optix Aqua | Slit Lamp Findings | Grade 0 | 46 eyes |
| Air Optix Aqua | Slit Lamp Findings | Grade 1 | 86 eyes |
| Air Optix Aqua | Slit Lamp Findings | Grade 2 | 0 eyes |
| Air Optix Aqua | Slit Lamp Findings | > Grade 2 | 0 eyes |
| Test Lens | Slit Lamp Findings | > Grade 2 | 0 eyes |
| Test Lens | Slit Lamp Findings | Grade 0 | 82 eyes |
| Test Lens | Slit Lamp Findings | Grade 2 | 0 eyes |
| Test Lens | Slit Lamp Findings | Grade 1 | 50 eyes |