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The objective of this study is to determine the product feasibility of the investigational contact lens (Test) when compared to the currently marketed Acuvue Oasys contact lens (Control) and the Air Optix Aqua contact lens (Control) when worn by adapted wearers of soft contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational contact lens | Experimental | Bausch & Lomb |
|
| Acuvue Oasys Contact Lens | Active Comparator | Johnson & Johnson Lens |
|
| Air Optix Aqua | Active Comparator | Ciba Vision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational contact lens | Device | After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type. |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens | Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable. | 7 days |
| Comfort Throughout the Day - Test Lens vs. Acuvue Oasys | Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Wettability, Test Lens vs. Acuvue Oasys | Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size). | 7 days |
| Lens Wettability, Test Lens vs. Air Optix Aqua |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Carains, MCOptom, PhD | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb | Rochester | New York | 14609 | United States |
Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Of the 120 participants enrolled 2 were ineligible at baseline and 2 discontinued following dispensing of lenses. 116 participants completed the study.
There were 120 participants enrolled in this bilateral eye, three-period crossover study at four investigative sites in the United States (US). All participants were adapted wearers of soft contact lenses. The first participant was enrolled in the study on 5/10/2010 and the last participant exited the study on 6/10/2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Over All Study | Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Crossover occurred following 1 week of lens wear. The 6 groups were as follows Test, Air Optix Aqua, Acuvue Oasys; Test, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, Test, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, Test; Acuvue Oasys, Test, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, Test. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 - Baseline |
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| Period 2 - Crossover |
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| Period 3- Crossover |
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All eligible, dispensed participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Over All Study | Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Crossover occurred following 1 week of lens wear. The 6 groups were as follows Test, Air Optix Aqua, Acuvue Oasys; Test, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, Test, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, Test; Acuvue Oasys, Test, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, Test. |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Lens Wettability, Test Lens vs. Acuvue Oasys | Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size). | All eligible, dispensed eyes | Posted | Number | eyes | 7 days | eyes | Participants |
|
7 Days
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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 Contact Lens | Bausch & Lomb Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type. |
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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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| Acuvue Oasys Contact Lens | Device | After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type. |
|
| Air Optix Aqua | Device | After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type. |
|
Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size). |
| 7 days |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens | Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable. | All eligible dispensed eyes | Posted | Least Squares Mean | Standard Deviation | units on a scale | 7 days | eyes | Participants |
|
|
|
| Primary | Comfort Throughout the Day - Test Lens vs. Acuvue Oasys | Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable. | All eligible, dispensed eyes | Posted | Least Squares Mean | Standard Deviation | units on a scale | 7 days | eyes | Participants |
|
|
|
| Secondary | Lens Wettability, Test Lens vs. Air Optix Aqua | Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size). | All eligible, dispensed eyes | Posted | Number | eyes | 7 days | eyes | Participants |
|
|
|
| 0 |
| 117 |
| 0 |
| 117 |
| EG001 | Acuvue Oasys Contact Lens | Johnson & Johnson Lens Acuvue Oasys Contact Lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type. | 0 | 117 | 0 | 117 |
| EG002 | Air Optix Aqua | Ciba Vision Air Optix Aqua: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type. | 0 | 117 | 0 | 117 |
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| Mild |
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| Moderate |
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| Severe |
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