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The purpose of this study is to compare the overall performance of a monthly replacement contact lens when worn for one month and when worn for two weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lotrafilcon B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lotrafilcon B contact lens | Device | Commercially marketed, silicone hydrogel contact lens worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort | Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent. | 2 weeks |
| Overall Comfort | Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent. | 4 weeks |
| End of Day Dryness | End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry. | 2 weeks |
| End of Day Dryness | End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry. | 4 weeks |
| Ocular Redness | Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red. | 2 weeks |
| Ocular Redness | Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Lotrafilcon B | Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lotrafilcon B | Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | This reporting group includes 114 enrolled and dispensed participants - i.e., 117 total minus 3 missing responses. |
| 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 | Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent. | Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | 2 weeks |
|
Adverse events were collected for the duration of the trial.
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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 B | Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Bergenske | Alcon Research | 1-800-241-7629 |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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|
| 4 weeks |
| Visual Clarity | Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent. | 2 weeks |
| Visual Clarity | Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent. | 4 weeks |
| Lens Deposits | Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe. | 2 weeks |
| Lens Deposits | Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe. | 4 weeks |
| Corrected Visual Acuity | Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity. | 2 weeks |
| Corrected Visual Acuity | Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity. | 4 weeks |
| Mean |
| Standard Deviation |
| years |
|
| Gender | This reporting group includes 115 enrolled and dispensed participants - i.e., 117 total minus 2 missing responses. | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Overall Comfort | Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent. | Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
|
|
| Primary | End of Day Dryness | End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry. | Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | 2 weeks |
|
|
|
| Primary | End of Day Dryness | End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry. | Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
|
|
| Primary | Ocular Redness | Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red. | Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | 2 weeks |
|
|
|
| Primary | Ocular Redness | Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red. | Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
|
|
| Primary | Visual Clarity | Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent. | Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | 2 weeks |
|
|
|
| Primary | Visual Clarity | Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent. | Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
|
|
| Primary | Lens Deposits | Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe. | Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | 2 weeks | Eyes | Participants |
|
|
|
| Primary | Lens Deposits | Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe. | Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks | eyes | Participants |
|
|
|
| Primary | Corrected Visual Acuity | Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity. | Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | logMAR | 2 weeks | Eyes | Participants |
|
|
|
| Primary | Corrected Visual Acuity | Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity. | Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | logMAR | 4 weeks | Eyes | Participants |
|
|
|
| 0 |
| 117 |
| 0 |
| 117 |
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.