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The objective of this study is to determine the clinical feasibility and to evaluate the product performance of an investigational contact lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational lens | Experimental | Bausch & Lomb investigational silicone hydrogel 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 contact lens worn on a daily wear basis for 1 week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). | At 1 week follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes With > Grade 2 Slit Lamp Findings | Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities. |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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A total of 66 participants (132 eyes) were enrolled in the study. One-half were randomized to receive the investigational lens, and the other half were randomized to receive the control lens. 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Lens Then Air Optix Aqua Lens | Bausch & Lomb investigational silicone hydrogel lens Investigational lens: Bausch & Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week. Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week. |
| FG001 | Air Optix Aqua Lens Then Investigational Lens | Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week. Bausch & Lomb investigational silicone hydrogel lens Investigational lens: Bausch & Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All participants received both treatment groups. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). | There were 65 subjects (130 eyes) in each group for this outcome measure. | Posted | Least Squares Mean | Standard Deviation | logMAR | At 1 week follow up | eyes | eyes |
|
2 weeks
Adverse events were not coded. Therefore source vocabulary is not applicable.
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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 | Investigational Lens | Bausch & Lomb investigational silicone hydrogel lens Investigational lens: Bausch & Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | 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 lens | Device | Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week. |
|
| At 1 week follow up |
| Symptoms and Complaints | At 1-Week Follow-up, subjects were asked to rate 16 common symptoms/complaints on a scale of 0 to 100, with 100 being the most favorable score. | At 1 week follow up |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Eyes With > Grade 2 Slit Lamp Findings | Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities. | There were 65 subjects (130 eyes) in each group for this outcome measure. | Posted | Count of Units | eyes | At 1 week follow up | eyes | eyes |
|
|
|
| Secondary | Symptoms and Complaints | At 1-Week Follow-up, subjects were asked to rate 16 common symptoms/complaints on a scale of 0 to 100, with 100 being the most favorable score. | There were 65 subjects (130 eyes) in each group for this outcome measure. | Posted | Least Squares Mean | Standard Deviation | score on a scale | At 1 week follow up | eyes | eyes |
|
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| EG001 | Air Optix Aqua Lens | Ciba Vision Air Optix Aqua contact lens Air Optix Aqua lens: Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week. | 0 | 66 | 0 | 66 |
Contact sponsor directly for details.
| Overall comfort |
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| Comfort at end of day |
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| Ease of handling/insertion |
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| Ease of handling/removal |
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| Dryness |
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| Itchiness |
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| Redness |
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| Vision upon insertion |
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| Vision |
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| Vision in low light |
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| Lens cleanness upon insertion |
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| Lens cleanness upon removal |
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| Overall impression |
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| Lens cleanness |
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