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The purpose of this study is to compare an experimental contact lens with a currently marketed contact lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Lotrafilcon A Contact Lens | Experimental | Lotrafilcon A experimental contact lens randomly assigned to one eye |
|
| Commercial Lotrafilcon A Contact Lens | Active Comparator | Lotrafilcon A commercial contact lens randomly assigned to one eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon A Experimental Contact Lens | Device | Experimental spherical, silicone hydrogel soft contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Vision | Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent. | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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One participant was enrolled but not dispensed due to failing inclusion criteria. This participant is included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Contact Lens / Commercial Contact Lens | Lotrafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Contact Lens / Commercial Contact Lens | Lotrafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear. |
| 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 | Overall Vision | Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent. | Per Protocol. Two participants were excluded from analysis due to major protocol deviations as determined by masked review. One participant was not analyzed due to discontinuation. | Posted | Mean | Standard Deviation | Units on a Scale | 1 week |
|
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 | Lotrafilcon A Commercial Contact Lens | Commercial spherical silicone hydrogel contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs | CIBA VISION | 1-800-241-7629 | priya.janakiraman@cibavision.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lotrafilcon A Commercial Contact Lens | Device | Commercially marketed spherical, silicone hydrogel soft contact lens |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Experimental spherical silicone hydrogel contact lens worn for one week on the same basis as habitual lenses -- ie., either on a daily wear or extended wear modality. |
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | Lotrafilcon A Experimental Contact Lens | Experimental spherical silicone hydrogel contact lens | 0 | 59 | 0 | 59 |
For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any pre-clinical and/or clinical data or impressions from this trial.