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The purpose of this study was to evaluate the subjective and objective performance and the physiological response to AIR OPTIX® COLORS soft contact lenses compared with AIR OPTIX® AQUA contact lenses in participants with normal eyes and prescription needs.
This study consisted of 7 scheduled visits conducted over a 3-month period. Enrolled participants were randomized (2:1) to receive either AIR OPTIX® COLORS lenses in both eyes or AIR OPTIX® AQUA lenses in both eyes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIR OPTIX® COLORS | Experimental | Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months |
|
| AIR OPTIX® AQUA | Active Comparator | Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B contact lens with color | Device | Silicone hydrogel contact lens with color |
|
| Measure | Description | Time Frame |
|---|---|---|
| Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage. | Up to Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Rating of Overall Vision | Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating. | Up to Month 3 |
| Subjective Rating of Overall Comfort |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Holden Thomas, OD | Alcon Research | Study Director |
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Of the 150 participants enrolled, 3 were exited from the study as screen failures prior to study product dispense. This reporting group includes all randomized and dispensed participants (147).
Participants were recruited from 10 investigational centers located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | AIR OPTIX® COLORS | Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months |
| FG001 | AIR OPTIX® AQUA | Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The analysis population includes all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | AIR OPTIX® COLORS | Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months |
| BG001 | AIR OPTIX® AQUA | Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months |
| 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 | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage. | The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation. | Posted | Number | Percentage of eyes | Up to Month 3 | Eyes | Participants |
|
Adverse events (AE)s were collected for the duration of the study (4 months). An AE was defined as any untoward medical occurrence in a subject exposed to a test article regardless of causal relationship with the test article.
The analysis population includes all enrolled participants who received study lenses. Adverse events were obtained as solicited comments from the participants and as observations by the Study Investigator as outlined in the study protocol following dispensation of study lenses.
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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 | AIR OPTIX® COLORS | Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharon Holden Thomas, Sr. Principal Clinical Scientist | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Lotrafilcon B contact lens | Device | Silicone hydrogel contact lens |
|
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Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating. |
| Up to Month 3 |
| Subjective Rating of Overall Handling | Overall handling, as rated by the participant on a 10-point scale, with 1 being difficult and 10 being easy. The participant rated both eyes together by providing one single rating. | Up to Month 3 |
| Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Lens fit, as assessed by the investigator for each eye individually. Lens fit was rated on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, -2=unacceptably tight. The combined percentage of lenses assessed as "optimal," "acceptably loose," or "acceptably tight" is reported. Lenses from both eyes contributed to the percentage. | Up to Month 3 |
| Lens Centration (Centered, Slight Decentration) | Lens centration, as assessed by the investigator for each eye individually. Lens centration was rated on a 5-point scale: 0=centered, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage. | Up to Month 3 |
| Dry Areas/Non-Wetting (None, Very Slight) | Dry areas/non-wetting (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Dry areas/non-wetting was rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage. | Up to Month 3 |
| Front Surface Deposits (None, Very Slight) | Front surface deposits on the contact lens, as assessed by the investigator for each eye individually. Front surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage. | Up to Month 3 |
| Back Surface Deposits (None, Very Slight) | Back surface deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage. | Up to Month 3 |
| Symptoms and Problems |
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| Unacceptable Subjective Vision |
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| Other Product Related |
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| Unrelated Medical Problem |
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| Other Non-Product Related |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | AIR OPTIX® AQUA | Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months |
|
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| Secondary | Subjective Rating of Overall Vision | Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating. | The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, "n" is the number of participants with non-missing values at the specific time point for each arm group. | Posted | Mean | Standard Deviation | Units on a scale | Up to Month 3 |
|
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| Secondary | Subjective Rating of Overall Comfort | Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating. | The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, "n" is the number of participants with non-missing values at the specific time point for each arm group. | Posted | Mean | Standard Deviation | Units on a scale | Up to Month 3 |
|
|
|
| Secondary | Subjective Rating of Overall Handling | Overall handling, as rated by the participant on a 10-point scale, with 1 being difficult and 10 being easy. The participant rated both eyes together by providing one single rating. | The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, "n" is the number of participants with non-missing values at the specific time point for each arm group. | Posted | Mean | Standard Deviation | Units on a scale | Up to Month 3 |
|
|
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| Secondary | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Lens fit, as assessed by the investigator for each eye individually. Lens fit was rated on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, -2=unacceptably tight. The combined percentage of lenses assessed as "optimal," "acceptably loose," or "acceptably tight" is reported. Lenses from both eyes contributed to the percentage. | The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation. | Posted | Number | Percentage of lenses | Up to Month 3 | Eyes | Participants |
|
|
|
| Secondary | Lens Centration (Centered, Slight Decentration) | Lens centration, as assessed by the investigator for each eye individually. Lens centration was rated on a 5-point scale: 0=centered, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage. | The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation. | Posted | Number | Percentage of lenses | Up to Month 3 | Eyes | Participants |
|
|
|
| Secondary | Dry Areas/Non-Wetting (None, Very Slight) | Dry areas/non-wetting (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Dry areas/non-wetting was rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage. | The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation. | Posted | Number | Percentage of lenses | Up to Month 3 | Eyes | Participants |
|
|
|
| Secondary | Front Surface Deposits (None, Very Slight) | Front surface deposits on the contact lens, as assessed by the investigator for each eye individually. Front surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage. | The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation. | Posted | Number | Percentage of lenses | Up to Month 3 | Eyes | Participants |
|
|
|
| Secondary | Back Surface Deposits (None, Very Slight) | Back surface deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage. | The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, "n" is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation. | Posted | Number | Percentage of lenses | Up to Month 3 | Eyes | Participants |
|
|
|
| 0 |
| 97 |
| 0 |
| 97 |
| EG001 | AIR OPTIX® AQUA | Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months | 0 | 50 | 0 | 50 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
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