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The purpose of this study is to compare subjective responses to two contact lenses after 15 minutes of wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Senofilcon A / Lotrafilcon A | Other | Senofilcon A, followed by Lotrafilcon A |
|
| Lotrafilcon A / Senofilcon A | Other | Lotrafilcon A, followed by Senofilcon A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon A contact lens | Device | Investigational, silicone hydrogel, spherical, soft contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comfort After Insertion | Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent. | 30-60 seconds after initial insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A / Lotrafilcon A | Senofilcon A, followed by Lotrafilcon A |
| FG001 | Lotrafilcon A / Senofilcon A | Lotrafilcon A, followed by Senofilcon A |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | This reporting group includes all enrolled and exposed subjects. |
| 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 | Comfort After Insertion | Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent. | Per protocol | Posted | Mean | Standard Deviation | Scale 1-10 | 30-60 seconds after initial insertion |
|
30 days, duration of the trial.
Subjects wore 2 pairs of contact lenses, 15 minutes per pair.
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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 | Senofilcon A | Commercially marketed, silicone hydrogel, spherical, soft 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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| Senofilcon A contact lens | Device | Commercially marketed, silicone hydrogel, spherical, soft contact lens |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 196 |
| 0 |
| 196 |
| EG001 | Lotrafilcon A | Investigational, silicone hydrogel, spherical, soft contact lens | 0 | 196 | 0 | 196 |
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.