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The purpose of this 3-month study is to evaluate subjective responses to an upgraded contact lens.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon A upgrade soft contact lens | Device | Silicone hydrogel contact lens approved for daily wear and extended wear up to 30 consecutive nights. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. | 3 months of wear, replacing lenses monthly |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Lens Fit | As assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded by eye on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight | 3 months of wear, replacing lenses monthly |
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Inclusion Criteria:
Exclusion Criteria:
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Thirteen US optometry sites recruited and enrolled subjects for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lotrafilcon A | Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lotrafilcon A | Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights). |
| 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 | Overall Comfort | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. | Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | units on a scale | 3 months of wear, replacing lenses monthly |
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Adverse event data were collected for the duration of the trial: 143 days.
This reporting group includes all enrolled and exposed participants.
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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 | Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sameena Haque-Khan, PhD, BSc(Hons)Optom, MCOptom, FAAO | Alcon Research, Ltd. | 1-800-241-7629 |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Time/Job Conflict |
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| Early exit - Site error |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
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| Participants |
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| Secondary | Overall Lens Fit | As assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded by eye on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight | Analysis conducted per protocol, with exclusions due to reasons such as: major protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | units on a scale | 3 months of wear, replacing lenses monthly | Eyes | Participants |
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| 118 |
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| 118 |
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.