Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lens.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Lens | Experimental | Bausch & Lomb investigational silicone hydrogel lens. |
|
| Acuvue Oasys Lens | Active Comparator | Johnson & Johnson Acuvue Oasys contact lens. |
|
| Air Optix Aqua Lens | Active Comparator | Ciba Vision Air Optix Aqua contact lens. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Lens | Device | Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity (Investigational vs Air Optix Aqua Lens) | The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens. | 1 week |
| Visual Acuity (Investigational vs Acuvue Oasys Lens) | The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens) | The mean differences in comfort between the investigational lens (RD2117-01) and the Acuvue Oasys control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score. | 1 week |
| Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tara Vaz, OD | Bausch & Lomb Incorporated | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | Rochester | New York | 14609 | United States |
144 participants were equally randomized to one of six treatment sequences. 142 participants completed the study.
This was a randomized, bilateral, three-way crossover, subject-masked study conducted at six sites in the United States. The first participant was enrolled 11/8/2010 and last participant exited on 12/23/2010.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Acuity (Investigational vs Air Optix Aqua Lens) | The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens. | All eligible, dispensed eyes | Posted | Least Squares Mean | Standard Deviation | LogMAR | 1 week | eyes | Participants |
|
3 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Study | Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Steffen | Bausch & Lomb | 585 338 6399 | robert.steffen@bausch.com |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Acuvue Oasys Lens | Device | Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week. |
|
| Air Optix Aqua Lens | Device | Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week. |
|
The mean differences in comfort between the investigational lens(RD2117-01) and the Air Optix Aqua control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score. |
| 1 week |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens) | The mean differences in comfort between the investigational lens (RD2117-01) and the Acuvue Oasys control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score. | 1-Week Follow-up, All Eligible, Dispensed Eyes | Posted | Least Squares Mean | Standard Deviation | units on a scale | 1 week | eyes | Participants |
|
|
|
| Primary | Visual Acuity (Investigational vs Acuvue Oasys Lens) | The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens. | All eligible, dispensed eyes | Posted | Least Squares Mean | Standard Deviation | LogMAR | 1 week | eyes | Participants |
|
|
|
| Secondary | Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens) | The mean differences in comfort between the investigational lens(RD2117-01) and the Air Optix Aqua control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score. | All eligible, dispensed eyes | Posted | Least Squares Mean | Standard Deviation | units on a scale | 1 week | eyes | Participants |
|
|
|
| 0 |
| 144 |
| 0 |
| 144 |
Not provided