Refractive Error
Conditions
Keywords
Myopia, Contact lenses
Brief summary
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.
Detailed description
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.
Interventions
Silicone hydrogel contact lens with color
Silicone hydrogel contact lens
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document. * Normal eyes and not using any ocular medications. * Willing to wear visitint or gray-colored spherical contact lenses in both eyes within available power ranges. * Manifest cylinder less than or equal to 0.75 diopter. * Best spectacle corrected visual acuity greater than or equal to 20/25. * Have current prescription glasses. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Anterior segment infection, inflammation, or abnormality. * Any active anterior segment ocular or systemic disease that would contraindicate contact lens wear. * Use of ocular or systemic medications for which contact lens wear could be contraindicated as determined by the investigator. * History of refractive surgery or irregular cornea. * History of pathologically dry eye. * Corneal vascularization greater than 1 millimeter of penetration. * History of herpetic keratitis. * Eye injury within 12 weeks immediately prior to enrollment in this trial. * Currently enrolled in any clinical trial or participation in any clinical trial within the previous 30 days. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Up to Month 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Rating of Overall Comfort | Up to Month 3 | 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. |
| Subjective Rating of Overall Handling | Up to Month 3 | 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. |
| Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Up to Month 3 | 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. |
| Subjective Rating of Overall Vision | Up to Month 3 | 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. |
| Dry Areas/Non-Wetting (None, Very Slight) | Up to Month 3 | 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. |
| Front Surface Deposits (None, Very Slight) | Up to Month 3 | 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. |
| Back Surface Deposits (None, Very Slight) | Up to Month 3 | 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. |
| Lens Centration (Centered, Slight Decentration) | Up to Month 3 | 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. |
Participant flow
Recruitment details
Participants were recruited from 10 investigational centers located in the United States.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| AIR OPTIX® COLORS Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months | 100 |
| AIR OPTIX® AQUA Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months | 50 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Biomicroscopy | 1 | 0 |
| Overall Study | Discomfort | 2 | 0 |
| Overall Study | Other Non-Product Related | 1 | 0 |
| Overall Study | Other Product Related | 1 | 0 |
| Overall Study | Symptoms and Problems | 1 | 0 |
| Overall Study | Unacceptable Subjective Vision | 1 | 0 |
| Overall Study | Unrelated Medical Problem | 0 | 1 |
Baseline characteristics
| Characteristic | AIR OPTIX® COLORS | AIR OPTIX® AQUA | Total |
|---|---|---|---|
| Age, Continuous | 31.0 years STANDARD_DEVIATION 10.28 | 31.0 years STANDARD_DEVIATION 9.91 | 31.0 years STANDARD_DEVIATION 10.13 |
| Sex: Female, Male Female | 76 Participants | 34 Participants | 110 Participants |
| Sex: Female, Male Male | 24 Participants | 16 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 97 | 0 / 50 |
| serious Total, serious adverse events | 0 / 97 | 0 / 50 |
Outcome results
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.
Time frame: Up to Month 3
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIR OPTIX® COLORS | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Dispense (n=180,98) | 100.0 Percentage of eyes |
| AIR OPTIX® COLORS | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Week 1 (n=180,98) | 100.0 Percentage of eyes |
| AIR OPTIX® COLORS | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Week 2 (n=180,96) | 100.0 Percentage of eyes |
| AIR OPTIX® COLORS | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Month 1 (n=180,98) | 100.0 Percentage of eyes |
| AIR OPTIX® COLORS | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Month 2 (n=179,98) | 100.0 Percentage of eyes |
| AIR OPTIX® COLORS | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Month 3 (n=178,98) | 100.0 Percentage of eyes |
| AIR OPTIX® AQUA | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Month 2 (n=179,98) | 100.0 Percentage of eyes |
| AIR OPTIX® AQUA | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Dispense (n=180,98) | 100.0 Percentage of eyes |
| AIR OPTIX® AQUA | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Month 1 (n=180,98) | 100.0 Percentage of eyes |
| AIR OPTIX® AQUA | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Week 1 (n=180,98) | 98.0 Percentage of eyes |
| AIR OPTIX® AQUA | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Month 3 (n=178,98) | 100.0 Percentage of eyes |
| AIR OPTIX® AQUA | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Week 2 (n=180,96) | 97.9 Percentage of eyes |
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.
Time frame: Up to Month 3
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIR OPTIX® COLORS | Back Surface Deposits (None, Very Slight) | Dispense (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® COLORS | Back Surface Deposits (None, Very Slight) | Week 1 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® COLORS | Back Surface Deposits (None, Very Slight) | Week 2 (n=180,96) | 99.4 Percentage of lenses |
| AIR OPTIX® COLORS | Back Surface Deposits (None, Very Slight) | Month 1 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® COLORS | Back Surface Deposits (None, Very Slight) | Month 2 (n=179,98) | 99.4 Percentage of lenses |
| AIR OPTIX® COLORS | Back Surface Deposits (None, Very Slight) | Month 3 (n=180,98) | 99.4 Percentage of lenses |
| AIR OPTIX® AQUA | Back Surface Deposits (None, Very Slight) | Month 2 (n=179,98) | 100.0 Percentage of lenses |
| AIR OPTIX® AQUA | Back Surface Deposits (None, Very Slight) | Dispense (n=180,98) | 99.0 Percentage of lenses |
| AIR OPTIX® AQUA | Back Surface Deposits (None, Very Slight) | Month 1 (n=180,98) | 95.9 Percentage of lenses |
| AIR OPTIX® AQUA | Back Surface Deposits (None, Very Slight) | Week 1 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® AQUA | Back Surface Deposits (None, Very Slight) | Month 3 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® AQUA | Back Surface Deposits (None, Very Slight) | Week 2 (n=180,96) | 100.0 Percentage of lenses |
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.
Time frame: Up to Month 3
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIR OPTIX® COLORS | Dry Areas/Non-Wetting (None, Very Slight) | Week 1 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® COLORS | Dry Areas/Non-Wetting (None, Very Slight) | Month 1 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® COLORS | Dry Areas/Non-Wetting (None, Very Slight) | Dispense (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® COLORS | Dry Areas/Non-Wetting (None, Very Slight) | Month 2 (n=179,98) | 100.0 Percentage of lenses |
| AIR OPTIX® COLORS | Dry Areas/Non-Wetting (None, Very Slight) | Week 2 (n=180,96) | 99.4 Percentage of lenses |
| AIR OPTIX® COLORS | Dry Areas/Non-Wetting (None, Very Slight) | Month 3 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® AQUA | Dry Areas/Non-Wetting (None, Very Slight) | Month 3 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® AQUA | Dry Areas/Non-Wetting (None, Very Slight) | Dispense (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® AQUA | Dry Areas/Non-Wetting (None, Very Slight) | Week 1 (n=180,98) | 99.0 Percentage of lenses |
| AIR OPTIX® AQUA | Dry Areas/Non-Wetting (None, Very Slight) | Week 2 (n=180,96) | 99.0 Percentage of lenses |
| AIR OPTIX® AQUA | Dry Areas/Non-Wetting (None, Very Slight) | Month 1 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® AQUA | Dry Areas/Non-Wetting (None, Very Slight) | Month 2 (n=179,98) | 100.0 Percentage of lenses |
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.
Time frame: Up to Month 3
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIR OPTIX® COLORS | Front Surface Deposits (None, Very Slight) | Dispense (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® COLORS | Front Surface Deposits (None, Very Slight) | Week 1 (n=180,98) | 96.7 Percentage of lenses |
| AIR OPTIX® COLORS | Front Surface Deposits (None, Very Slight) | Week 2 (n=180,96) | 97.8 Percentage of lenses |
| AIR OPTIX® COLORS | Front Surface Deposits (None, Very Slight) | Month 1 (n=180,98) | 96.7 Percentage of lenses |
| AIR OPTIX® COLORS | Front Surface Deposits (None, Very Slight) | Month 2 (n=179,98) | 97.2 Percentage of lenses |
| AIR OPTIX® COLORS | Front Surface Deposits (None, Very Slight) | Month 3 (n=180,98) | 94.4 Percentage of lenses |
| AIR OPTIX® AQUA | Front Surface Deposits (None, Very Slight) | Month 2 (n=179,98) | 98.0 Percentage of lenses |
| AIR OPTIX® AQUA | Front Surface Deposits (None, Very Slight) | Dispense (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® AQUA | Front Surface Deposits (None, Very Slight) | Month 1 (n=180,98) | 95.9 Percentage of lenses |
| AIR OPTIX® AQUA | Front Surface Deposits (None, Very Slight) | Week 1 (n=180,98) | 98.0 Percentage of lenses |
| AIR OPTIX® AQUA | Front Surface Deposits (None, Very Slight) | Month 3 (n=180,98) | 98.0 Percentage of lenses |
| AIR OPTIX® AQUA | Front Surface Deposits (None, Very Slight) | Week 2 (n=180,96) | 99.0 Percentage of lenses |
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.
Time frame: Up to Month 3
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIR OPTIX® COLORS | Lens Centration (Centered, Slight Decentration) | Dispense (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® COLORS | Lens Centration (Centered, Slight Decentration) | Week 1 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® COLORS | Lens Centration (Centered, Slight Decentration) | Week 2 (n=180,96) | 100.0 Percentage of lenses |
| AIR OPTIX® COLORS | Lens Centration (Centered, Slight Decentration) | Month 1 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® COLORS | Lens Centration (Centered, Slight Decentration) | Month 2 (n=179,98) | 98.3 Percentage of lenses |
| AIR OPTIX® COLORS | Lens Centration (Centered, Slight Decentration) | Month 3 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® AQUA | Lens Centration (Centered, Slight Decentration) | Month 2 (n=179,98) | 100.0 Percentage of lenses |
| AIR OPTIX® AQUA | Lens Centration (Centered, Slight Decentration) | Dispense (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® AQUA | Lens Centration (Centered, Slight Decentration) | Month 1 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® AQUA | Lens Centration (Centered, Slight Decentration) | Week 1 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® AQUA | Lens Centration (Centered, Slight Decentration) | Month 3 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® AQUA | Lens Centration (Centered, Slight Decentration) | Week 2 (n=180,96) | 100.0 Percentage of lenses |
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.
Time frame: Up to Month 3
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AIR OPTIX® COLORS | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Dispense (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® COLORS | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Week 1 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® COLORS | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Week 2 (n=180,96) | 100.0 Percentage of lenses |
| AIR OPTIX® COLORS | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Month 1 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® COLORS | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Month 2 (n=179,98) | 100.0 Percentage of lenses |
| AIR OPTIX® COLORS | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Month 3 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® AQUA | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Month 2 (n=179,98) | 100.0 Percentage of lenses |
| AIR OPTIX® AQUA | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Dispense (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® AQUA | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Month 1 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® AQUA | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Week 1 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® AQUA | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Month 3 (n=180,98) | 100.0 Percentage of lenses |
| AIR OPTIX® AQUA | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Week 2 (n=180,96) | 100.0 Percentage of lenses |
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.
Time frame: Up to Month 3
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIR OPTIX® COLORS | Subjective Rating of Overall Comfort | Week 1 (n=90,49) | 8.3 Units on a scale | Standard Deviation 1.9 |
| AIR OPTIX® COLORS | Subjective Rating of Overall Comfort | Month 1 (n=90,49) | 8.4 Units on a scale | Standard Deviation 1.8 |
| AIR OPTIX® COLORS | Subjective Rating of Overall Comfort | Dispense (n=90,49) | 9.1 Units on a scale | Standard Deviation 1.5 |
| AIR OPTIX® COLORS | Subjective Rating of Overall Comfort | Month 2 (n=90,49) | 8.5 Units on a scale | Standard Deviation 1.8 |
| AIR OPTIX® COLORS | Subjective Rating of Overall Comfort | Week 2 (n=90,48) | 8.6 Units on a scale | Standard Deviation 1.7 |
| AIR OPTIX® COLORS | Subjective Rating of Overall Comfort | Month 3 (n=90,49) | 8.6 Units on a scale | Standard Deviation 1.7 |
| AIR OPTIX® AQUA | Subjective Rating of Overall Comfort | Week 2 (n=90,48) | 9.3 Units on a scale | Standard Deviation 0.8 |
| AIR OPTIX® AQUA | Subjective Rating of Overall Comfort | Dispense (n=90,49) | 9.2 Units on a scale | Standard Deviation 0.9 |
| AIR OPTIX® AQUA | Subjective Rating of Overall Comfort | Week 1 (n=90,49) | 9.0 Units on a scale | Standard Deviation 1.2 |
| AIR OPTIX® AQUA | Subjective Rating of Overall Comfort | Month 3 (n=90,49) | 8.9 Units on a scale | Standard Deviation 1.1 |
| AIR OPTIX® AQUA | Subjective Rating of Overall Comfort | Month 1 (n=90,49) | 8.9 Units on a scale | Standard Deviation 1.1 |
| AIR OPTIX® AQUA | Subjective Rating of Overall Comfort | Month 2 (n=90,49) | 8.8 Units on a scale | Standard Deviation 1.1 |
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.
Time frame: Up to Month 3
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIR OPTIX® COLORS | Subjective Rating of Overall Handling | Dispense (n=90,49) | 9.3 Units on a scale | Standard Deviation 1.3 |
| AIR OPTIX® COLORS | Subjective Rating of Overall Handling | Week 1 (n=90,49) | 9.4 Units on a scale | Standard Deviation 1 |
| AIR OPTIX® COLORS | Subjective Rating of Overall Handling | Week 2 (n=90,48) | 9.4 Units on a scale | Standard Deviation 1 |
| AIR OPTIX® COLORS | Subjective Rating of Overall Handling | Month 1 (n=90,49) | 9.5 Units on a scale | Standard Deviation 0.9 |
| AIR OPTIX® COLORS | Subjective Rating of Overall Handling | Month 2 (n=90,49) | 9.4 Units on a scale | Standard Deviation 1.2 |
| AIR OPTIX® COLORS | Subjective Rating of Overall Handling | Month 3 (n=90,49) | 9.4 Units on a scale | Standard Deviation 1 |
| AIR OPTIX® AQUA | Subjective Rating of Overall Handling | Month 2 (n=90,49) | 9.4 Units on a scale | Standard Deviation 0.9 |
| AIR OPTIX® AQUA | Subjective Rating of Overall Handling | Dispense (n=90,49) | 9.5 Units on a scale | Standard Deviation 0.8 |
| AIR OPTIX® AQUA | Subjective Rating of Overall Handling | Month 1 (n=90,49) | 9.4 Units on a scale | Standard Deviation 0.8 |
| AIR OPTIX® AQUA | Subjective Rating of Overall Handling | Week 1 (n=90,49) | 9.2 Units on a scale | Standard Deviation 1.2 |
| AIR OPTIX® AQUA | Subjective Rating of Overall Handling | Month 3 (n=90,49) | 9.3 Units on a scale | Standard Deviation 0.9 |
| AIR OPTIX® AQUA | Subjective Rating of Overall Handling | Week 2 (n=90,48) | 9.4 Units on a scale | Standard Deviation 0.9 |
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.
Time frame: Up to Month 3
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIR OPTIX® COLORS | Subjective Rating of Overall Vision | Dispense (n=90,49) | 8.3 Units on a scale | Standard Deviation 1.7 |
| AIR OPTIX® COLORS | Subjective Rating of Overall Vision | Week 1 (n=90,49) | 8.0 Units on a scale | Standard Deviation 2.1 |
| AIR OPTIX® COLORS | Subjective Rating of Overall Vision | Week 2 (n=90,48) | 8.1 Units on a scale | Standard Deviation 2 |
| AIR OPTIX® COLORS | Subjective Rating of Overall Vision | Month 1 (n=90,49) | 8.4 Units on a scale | Standard Deviation 1.9 |
| AIR OPTIX® COLORS | Subjective Rating of Overall Vision | Month 2 (n=90,49) | 8.5 Units on a scale | Standard Deviation 1.8 |
| AIR OPTIX® COLORS | Subjective Rating of Overall Vision | Month 3 (n=90,49) | 8.4 Units on a scale | Standard Deviation 1.8 |
| AIR OPTIX® AQUA | Subjective Rating of Overall Vision | Month 2 (n=90,49) | 9.3 Units on a scale | Standard Deviation 1 |
| AIR OPTIX® AQUA | Subjective Rating of Overall Vision | Dispense (n=90,49) | 9.5 Units on a scale | Standard Deviation 0.9 |
| AIR OPTIX® AQUA | Subjective Rating of Overall Vision | Month 1 (n=90,49) | 9.3 Units on a scale | Standard Deviation 0.9 |
| AIR OPTIX® AQUA | Subjective Rating of Overall Vision | Week 1 (n=90,49) | 9.4 Units on a scale | Standard Deviation 0.9 |
| AIR OPTIX® AQUA | Subjective Rating of Overall Vision | Month 3 (n=90,49) | 9.3 Units on a scale | Standard Deviation 1 |
| AIR OPTIX® AQUA | Subjective Rating of Overall Vision | Week 2 (n=90,48) | 9.4 Units on a scale | Standard Deviation 0.9 |