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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Air Optix Aqua | Active Comparator | Ciba Vision daily wear contact lens |
|
| Test Lens | Experimental | Investigational silicone hydrogel contact lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test lens | Device | Investigational silicone hydrogel contact lens worn on a daily wear basis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Dispensing & 1-week follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week |
| Comfort |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Barna | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb, Incorporated | Rochester | New York | 14609 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Air Optix Aqua Then Test Lens | Ciba Vision Air Optix Aqua contact lens. Lenses were worn on a daily wear basis. After one week participants crossed over to the Test lens. All subjects were provided with Bausch + Lomb renu® fresh™ multi-purpose solution and lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses, and Bausch + Lomb Sensitive Eyes® Rewetting Drops for use as needed during the study. |
| FG001 | Test Lens Then Air Optix Aqua | The test lens was an Investigational silicone hydrogel contact lens. Lenses were worn on a daily wear basis. After one week participants crossed over to Ciba Vision Air Optix Aqua contact lens.. All subjects were provided with Bausch + Lomb renu® fresh™ multi-purpose solution and lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses, and Bausch + Lomb Sensitive Eyes® Rewetting Drops for use as needed during the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All eligible enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | 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. | All Eligible, Dispensed Eyes | Posted | Least Squares Mean | Standard Deviation | logMAR | Dispensing & 1-week follow up | eyes | Participants |
|
1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Air Optix Aqua | Ciba Vision daily wear contact lens Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Steffen | Bausch & Lomb | 585 338 6399 | robert.steffen@bausch.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Air Optix Aqua |
| Device |
Air Optix Aqua contact lens worn on a daily wear basis |
|
At 1-Week Follow-up, participants rated lens comfort on a scale of 0 to 100, with 100 being the most favorable score. |
| 1 Weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | All Dispensed Eyes | Posted | Number | eyes | 1 week | eyes | Participants |
|
|
|
| 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. | Posted | Least Squares Mean | Standard Deviation | units on a scale | 1 Weeks | eyes | Participants |
|
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| EG001 | Test Lens | Investigational silicone hydrogel contact lens Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis | 0 | 66 | 0 | 66 |
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| Grade 2 |
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| > Grade 2 |
|