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The purpose of this trial is to compare two different contact lenses during 4 weeks of wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lotrafilcon A | Experimental | Investigational, spherical, silicone hydrogel contact lenses |
|
| Comfilcon A | Active Comparator | Commercially marketed, spherical, silicone hydrogel contact lenses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon A contact lens | Device | Silicone hydrogel contact lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort at End of Day | Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent. | After 4 weeks of wear |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Lotrafilcon A | Investigational, spherical, silicone hydrogel contact lenses |
| FG001 | Comfilcon A | Commercially marketed, spherical, silicone hydrogel contact lenses |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lotrafilcon A | Investigational, spherical, silicone hydrogel contact lenses |
| BG001 | Comfilcon A | Commercially marketed, spherical, silicone hydrogel contact lenses |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Comfort at End of Day | Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent. | One subject in the Lotrafilcon A arm was excluded from efficacy analysis due to a protocol deviation. | Posted | Mean | Standard Deviation | Scale of 1-10 | After 4 weeks of wear |
|
8 weeks, duration of the study
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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 | Investigational, spherical, silicone hydrogel contact lenses |
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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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| Comfilcon A contact lens |
| Device |
Silicone hydrogel contact lens |
|
| death in the family |
|
| Lost to Follow-up |
|
| deposits on contact lens |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 107 |
| 0 |
| 107 |
| EG001 | Comfilcon A | Commercially marketed, spherical, silicone hydrogel contact lenses | 0 | 106 | 0 | 106 |
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 preclinical and/or clinical data or impressions from this trial.