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 lenses.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Lens | Experimental | Bausch & Lomb investigational silicone hydrogel contact lens for 1 week; then issued Air Optix Aqua Lens for 1 week. |
|
| Air Optix Aqua Lens | Active Comparator | Ciba Vision Air Optix Aqua contact lens for 1 week; then issued Investigational Lens for 1 week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Lens | Device | Lenses worn on a daily wear basis for one week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance High Contrast logMAR Visual Acuity at 1 Week | Mean difference in distance high contrast logMAR over all lens VAs (visual acuity) from Baseline and 1 Week | Baseline & 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Slit Lamp Findings ≥ Grade 2 | Slit lamp findings are measured on a scale of 0-4, where 0=none, and 4=severe. The slit lamp exam is a routine procedure done to evaluate eye health and determine eligibility for clinical trial. It provides view of the different parts of the eye. During the exam, a doctor can look at the front parts of the eye, including the cornea, the lens, the iris and other parts of the anterior segment of the eye. Fluorescein dye may be used during a slit lamp examination to make it easier to detect inflammation, infections, or injured area on the cornea. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Steffen, OD, MS | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb | Rochester | New York | 14609 | United States |
66 participants enrolled; 64 participants completed. Half wore Investigational Lens for 1 week then crossed over to Air Optix Aqua lens for 1 week. The other half wore Air Optix Aqua Lens for 1 week then crossed over to Investigational Lens for 1 week. The order of lens use was randomized and participant-masked.
Participants recruited for this 2-week study conducted at three investigational sites in the USA. The first participant was enrolled on 12/17/2010; the last participant exited the study on 01/20/2011.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Lens First, Then Air Optix Aqua Lens | Enrolled participants spent 1 week using Investigational Lens, and then crossed over to 1 week using Air Optix Aqua lens. The order of contact lens use was randomized and participant-masked. |
| FG001 | Air Optix Aqua Lens First, Then Investigational Lens | Enrolled participants spent 1 week using Air Optix Aqua Lens, and then crossed over to 1 week using Investigational Lens. The order of contact lens use was randomized and participant-masked. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 - First Intervention |
| |||||||||||||
| Week 2 - Crossover Intervention |
|
All eligible enrolled participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | All eligible enrolled participants |
| 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 | Distance High Contrast logMAR Visual Acuity at 1 Week | Mean difference in distance high contrast logMAR over all lens VAs (visual acuity) from Baseline and 1 Week | All eligible, dispensed eyes | Posted | Least Squares Mean | Standard Deviation | logMAR | Baseline & 1 week | eyes | Participants |
|
1 week
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 | Investigational Lens | Bausch & Lomb investigational silicone hydrogel contact lens Investigational Lens: Lenses worn on a daily wear basis 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
| Air Optix Aqua lens | Device | Lenses worn on a daily wear basis for one week |
|
| 1 week |
| Overall Comfort | Comfort measured by participant on a scale of 0-100 with 100 being the most favorable. | 1 week |
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Slit Lamp Findings ≥ Grade 2 | Slit lamp findings are measured on a scale of 0-4, where 0=none, and 4=severe. The slit lamp exam is a routine procedure done to evaluate eye health and determine eligibility for clinical trial. It provides view of the different parts of the eye. During the exam, a doctor can look at the front parts of the eye, including the cornea, the lens, the iris and other parts of the anterior segment of the eye. Fluorescein dye may be used during a slit lamp examination to make it easier to detect inflammation, infections, or injured area on the cornea. | All dispensed eyes | Posted | Number | eyes | 1 week | eyes | Participants |
|
|
|
| Secondary | Overall Comfort | Comfort measured by participant on a scale of 0-100 with 100 being the most favorable. | All eligible dispensed eyes | Posted | Least Squares Mean | Standard Deviation | units on a scale | 1 week | eyes | Participants |
|
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| EG001 | Air Optix Aqua Lens | Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Lenses worn on a daily wear basis for one week | 0 | 66 | 0 | 66 |
Not provided