Astigmatism, Myopia, Refractive Error
Conditions
Keywords
toric, contact lenses, daily disposable contact lenses, astigmatism, soft contact lenses, contact lens comfort
Brief summary
The purpose of this study was to demonstrate substantial equivalence of an investigational toric soft contact lens to the commercially available Focus® DAILIES® Toric soft contact lens when worn in a daily wear, daily disposable mode for three months.
Detailed description
Eligible participants were randomized 2:1 to wear either DAILIES® AquaComfort Plus® Toric or Focus® DAILIES® Toric.
Interventions
DEVICENelfilcon A toric contact lenses (with comfort additives)
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and participant must sign Assent document. * Normal eyes not using any ocular medications that would contraindicate lens wear. * Willing and able to wear toric contact lenses in both eyes within the available range of powers for this trial. * Spectacle cylinder prescription between 0.50 and 2.00 diopters. * Best spectacle corrected visual acuity 20/25 (Snellen) or better in each eye at distance. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Anterior segment infection, inflammation, or abnormality. * Any active anterior segment or systemic disease that would contraindicate contact lens wear. * Use of systemic medications that would contraindicate lens wear. * Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study. * History of herpetic keratitis. * History of refractive surgery or irregular cornea. * History of pathologically dry eye. * Corneal vascularization greater than 1 mm of penetration. * Eye injury within twelve weeks immediately prior to enrollment in this trial. * Participation in a contact lens or contact lens care product clinical trial within the previous 30 days, or concurrent participation in any clinical trial. * 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 Insertion Comfort | Up to Month 3 | Insertion comfort (30 seconds to 1 minute), 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 End of Day Comfort | Up to Month 3 | End of day 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 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 End of Day Dryness | Up to Month 3 | End of day dryness, as rated by the participant on a 10-point scale, with 1 being dry and 10 being not dry. The participant rated both eyes together by providing one single rating. |
| 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. |
| 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 Centration (Centered, Slight Decentration) | Up to Month 3 | Lens centration, as assessed by the investigator for each eye individually. Lens centration was graded 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. |
| 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 graded on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -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. |
| Front Surface Wettability (None, Very Slight) | Up to Month 3 | Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Front surface wettability was graded 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 graded 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 Debris/Deposits (None, Very Slight) | Up to Month 3 | Back surface debris/deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface debris/deposits were graded 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. |
Participant flow
Recruitment details
Participants were recruited from ten US study centers.
Pre-assignment details
Of the 154 participants enrolled, ten participants were considered enrolled, but not dispensed, due to not meeting inclusion criteria or withdrawal of consent. This reporting group includes all enrolled and dispensed participants (144).
Participants by arm
| Arm | Count |
|---|---|
| DAILIES® AquaComfort Plus® Toric Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months | 95 |
| Focus® DAILIES® Toric Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months | 49 |
| Total | 144 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Noncompliance | 1 | 1 |
| Overall Study | Subject decision unrelated to an AE | 1 | 1 |
Baseline characteristics
| Characteristic | DAILIES® AquaComfort Plus® Toric | Focus® DAILIES® Toric | Total |
|---|---|---|---|
| Age Continuous | 33.6 years STANDARD_DEVIATION 12.5 | 37.2 years STANDARD_DEVIATION 11.4 | 34.9 years STANDARD_DEVIATION 12.2 |
| Sex: Female, Male Female | 73 Participants | 28 Participants | 101 Participants |
| Sex: Female, Male Male | 22 Participants | 21 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 95 | 0 / 49 |
| serious Total, serious adverse events | 0 / 95 | 0 / 49 |
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: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DAILIES® AquaComfort Plus® Toric | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Dispense | 98.9 Percentage of eyes |
| DAILIES® AquaComfort Plus® Toric | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Week 1 | 98.9 Percentage of eyes |
| DAILIES® AquaComfort Plus® Toric | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Week 2 | 98.9 Percentage of eyes |
| DAILIES® AquaComfort Plus® Toric | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Month 1 | 98.9 Percentage of eyes |
| DAILIES® AquaComfort Plus® Toric | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Month 2 | 98.9 Percentage of eyes |
| DAILIES® AquaComfort Plus® Toric | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Month 3 | 98.9 Percentage of eyes |
| Focus® DAILIES® Toric | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Month 2 | 98.9 Percentage of eyes |
| Focus® DAILIES® Toric | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Dispense | 98.9 Percentage of eyes |
| Focus® DAILIES® Toric | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Month 1 | 97.8 Percentage of eyes |
| Focus® DAILIES® Toric | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Week 1 | 97.8 Percentage of eyes |
| Focus® DAILIES® Toric | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Month 3 | 96.7 Percentage of eyes |
| Focus® DAILIES® Toric | Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | Week 2 | 97.8 Percentage of eyes |
Secondary
Back Surface Debris/Deposits (None, Very Slight)
Back surface debris/deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface debris/deposits were graded 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: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DAILIES® AquaComfort Plus® Toric | Back Surface Debris/Deposits (None, Very Slight) | Dispense | 100 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Back Surface Debris/Deposits (None, Very Slight) | Week 1 | 98.9 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Back Surface Debris/Deposits (None, Very Slight) | Week 2 | 100 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Back Surface Debris/Deposits (None, Very Slight) | Month 1 | 100 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Back Surface Debris/Deposits (None, Very Slight) | Month 2 | 96.6 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Back Surface Debris/Deposits (None, Very Slight) | Month 3 | 99.4 Percentage of lenses |
| Focus® DAILIES® Toric | Back Surface Debris/Deposits (None, Very Slight) | Month 2 | 96.7 Percentage of lenses |
| Focus® DAILIES® Toric | Back Surface Debris/Deposits (None, Very Slight) | Dispense | 100 Percentage of lenses |
| Focus® DAILIES® Toric | Back Surface Debris/Deposits (None, Very Slight) | Month 1 | 100 Percentage of lenses |
| Focus® DAILIES® Toric | Back Surface Debris/Deposits (None, Very Slight) | Week 1 | 100 Percentage of lenses |
| Focus® DAILIES® Toric | Back Surface Debris/Deposits (None, Very Slight) | Month 3 | 98.9 Percentage of lenses |
| Focus® DAILIES® Toric | Back Surface Debris/Deposits (None, Very Slight) | Week 2 | 100 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 graded 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: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DAILIES® AquaComfort Plus® Toric | Front Surface Deposits (None, Very Slight) | Week 1 | 96.1 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Front Surface Deposits (None, Very Slight) | Month 1 | 98.9 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Front Surface Deposits (None, Very Slight) | Dispense | 100 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Front Surface Deposits (None, Very Slight) | Month 2 | 98.9 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Front Surface Deposits (None, Very Slight) | Week 2 | 98.3 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Front Surface Deposits (None, Very Slight) | Month 3 | 96.1 Percentage of lenses |
| Focus® DAILIES® Toric | Front Surface Deposits (None, Very Slight) | Week 2 | 100 Percentage of lenses |
| Focus® DAILIES® Toric | Front Surface Deposits (None, Very Slight) | Dispense | 100 Percentage of lenses |
| Focus® DAILIES® Toric | Front Surface Deposits (None, Very Slight) | Week 1 | 100 Percentage of lenses |
| Focus® DAILIES® Toric | Front Surface Deposits (None, Very Slight) | Month 3 | 97.8 Percentage of lenses |
| Focus® DAILIES® Toric | Front Surface Deposits (None, Very Slight) | Month 1 | 99 Percentage of lenses |
| Focus® DAILIES® Toric | Front Surface Deposits (None, Very Slight) | Month 2 | 96.7 Percentage of lenses |
Secondary
Front Surface Wettability (None, Very Slight)
Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Front surface wettability was graded 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: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DAILIES® AquaComfort Plus® Toric | Front Surface Wettability (None, Very Slight) | Dispense | 99.4 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Front Surface Wettability (None, Very Slight) | Week 1 | 92.2 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Front Surface Wettability (None, Very Slight) | Week 2 | 94.9 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Front Surface Wettability (None, Very Slight) | Month 1 | 97.2 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Front Surface Wettability (None, Very Slight) | Month 2 | 91.1 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Front Surface Wettability (None, Very Slight) | Month 3 | 91.6 Percentage of lenses |
| Focus® DAILIES® Toric | Front Surface Wettability (None, Very Slight) | Month 2 | 86.7 Percentage of lenses |
| Focus® DAILIES® Toric | Front Surface Wettability (None, Very Slight) | Dispense | 100 Percentage of lenses |
| Focus® DAILIES® Toric | Front Surface Wettability (None, Very Slight) | Month 1 | 93.5 Percentage of lenses |
| Focus® DAILIES® Toric | Front Surface Wettability (None, Very Slight) | Week 1 | 97.8 Percentage of lenses |
| Focus® DAILIES® Toric | Front Surface Wettability (None, Very Slight) | Month 3 | 88.0 Percentage of lenses |
| Focus® DAILIES® Toric | Front Surface Wettability (None, Very Slight) | Week 2 | 95.6 Percentage of lenses |
Secondary
Lens Centration (Centered, Slight Decentration)
Lens centration, as assessed by the investigator for each eye individually. Lens centration was graded 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: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DAILIES® AquaComfort Plus® Toric | Lens Centration (Centered, Slight Decentration) | Dispense | 97.8 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Lens Centration (Centered, Slight Decentration) | Week 1 | 100 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Lens Centration (Centered, Slight Decentration) | Week 2 | 100 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Lens Centration (Centered, Slight Decentration) | Month 1 | 100 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Lens Centration (Centered, Slight Decentration) | Month 2 | 100 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Lens Centration (Centered, Slight Decentration) | Month 3 | 99.4 Percentage of lenses |
| Focus® DAILIES® Toric | Lens Centration (Centered, Slight Decentration) | Month 2 | 100 Percentage of lenses |
| Focus® DAILIES® Toric | Lens Centration (Centered, Slight Decentration) | Dispense | 98.9 Percentage of lenses |
| Focus® DAILIES® Toric | Lens Centration (Centered, Slight Decentration) | Month 1 | 100 Percentage of lenses |
| Focus® DAILIES® Toric | Lens Centration (Centered, Slight Decentration) | Week 1 | 100 Percentage of lenses |
| Focus® DAILIES® Toric | Lens Centration (Centered, Slight Decentration) | Month 3 | 100 Percentage of lenses |
| Focus® DAILIES® Toric | Lens Centration (Centered, Slight Decentration) | Week 2 | 100 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 graded on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -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: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DAILIES® AquaComfort Plus® Toric | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Dispense | 100 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Week 1 | 100 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Week 2 | 100 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Month 1 | 100 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Month 2 | 100 Percentage of lenses |
| DAILIES® AquaComfort Plus® Toric | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Month 3 | 100 Percentage of lenses |
| Focus® DAILIES® Toric | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Month 2 | 100 Percentage of lenses |
| Focus® DAILIES® Toric | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Dispense | 100 Percentage of lenses |
| Focus® DAILIES® Toric | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Month 1 | 100 Percentage of lenses |
| Focus® DAILIES® Toric | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Week 1 | 100 Percentage of lenses |
| Focus® DAILIES® Toric | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Month 3 | 100 Percentage of lenses |
| Focus® DAILIES® Toric | Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | Week 2 | 100 Percentage of lenses |
Secondary
Subjective Rating of End of Day Comfort
End of day 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: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of End of Day Comfort | Week 2 | 7.6 Units on a scale | Standard Deviation 2.1 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of End of Day Comfort | Month 2 | 7.6 Units on a scale | Standard Deviation 2.1 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of End of Day Comfort | Month 1 | 7.6 Units on a scale | Standard Deviation 2 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of End of Day Comfort | Month 3 | 7.7 Units on a scale | Standard Deviation 1.9 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of End of Day Comfort | Week 1 | 7.2 Units on a scale | Standard Deviation 2.5 |
| Focus® DAILIES® Toric | Subjective Rating of End of Day Comfort | Month 3 | 7.8 Units on a scale | Standard Deviation 2 |
| Focus® DAILIES® Toric | Subjective Rating of End of Day Comfort | Week 1 | 7.6 Units on a scale | Standard Deviation 2.1 |
| Focus® DAILIES® Toric | Subjective Rating of End of Day Comfort | Week 2 | 7.9 Units on a scale | Standard Deviation 1.8 |
| Focus® DAILIES® Toric | Subjective Rating of End of Day Comfort | Month 1 | 8.2 Units on a scale | Standard Deviation 1.4 |
| Focus® DAILIES® Toric | Subjective Rating of End of Day Comfort | Month 2 | 7.9 Units on a scale | Standard Deviation 1.9 |
Secondary
Subjective Rating of End of Day Dryness
End of day dryness, as rated by the participant on a 10-point scale, with 1 being dry and 10 being not dry. The participant rated both eyes together by providing one single rating.
Time frame: Up to Month 3
Population: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of End of Day Dryness | Week 2 | 7.2 Units on a scale | Standard Deviation 2.3 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of End of Day Dryness | Month 2 | 7.4 Units on a scale | Standard Deviation 2.1 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of End of Day Dryness | Month 1 | 7.3 Units on a scale | Standard Deviation 2 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of End of Day Dryness | Month 3 | 7.5 Units on a scale | Standard Deviation 2 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of End of Day Dryness | Week 1 | 7.1 Units on a scale | Standard Deviation 2.7 |
| Focus® DAILIES® Toric | Subjective Rating of End of Day Dryness | Month 3 | 7.4 Units on a scale | Standard Deviation 2.2 |
| Focus® DAILIES® Toric | Subjective Rating of End of Day Dryness | Week 1 | 7.1 Units on a scale | Standard Deviation 2.3 |
| Focus® DAILIES® Toric | Subjective Rating of End of Day Dryness | Week 2 | 7.6 Units on a scale | Standard Deviation 2.1 |
| Focus® DAILIES® Toric | Subjective Rating of End of Day Dryness | Month 1 | 7.9 Units on a scale | Standard Deviation 1.6 |
| Focus® DAILIES® Toric | Subjective Rating of End of Day Dryness | Month 2 | 7.6 Units on a scale | Standard Deviation 2 |
Secondary
Subjective Rating of Insertion Comfort
Insertion comfort (30 seconds to 1 minute), 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: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Insertion Comfort | Dispense | 8.9 Units on a scale | Standard Deviation 1.3 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Insertion Comfort | Week 1 | 9.0 Units on a scale | Standard Deviation 1.3 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Insertion Comfort | Week 2 | 9.0 Units on a scale | Standard Deviation 1.1 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Insertion Comfort | Month 1 | 9.0 Units on a scale | Standard Deviation 1.1 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Insertion Comfort | Month 2 | 9.1 Units on a scale | Standard Deviation 0.9 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Insertion Comfort | Month 3 | 9.2 Units on a scale | Standard Deviation 1 |
| Focus® DAILIES® Toric | Subjective Rating of Insertion Comfort | Month 2 | 9.3 Units on a scale | Standard Deviation 0.9 |
| Focus® DAILIES® Toric | Subjective Rating of Insertion Comfort | Dispense | 9.0 Units on a scale | Standard Deviation 1.4 |
| Focus® DAILIES® Toric | Subjective Rating of Insertion Comfort | Month 1 | 9.1 Units on a scale | Standard Deviation 1.1 |
| Focus® DAILIES® Toric | Subjective Rating of Insertion Comfort | Week 1 | 9.0 Units on a scale | Standard Deviation 1.4 |
| Focus® DAILIES® Toric | Subjective Rating of Insertion Comfort | Month 3 | 9.1 Units on a scale | Standard Deviation 1.3 |
| Focus® DAILIES® Toric | Subjective Rating of Insertion Comfort | Week 2 | 9.1 Units on a scale | Standard Deviation 1.2 |
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: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Overall Comfort | Month 3 | 8.4 Units on a scale | Standard Deviation 1.4 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Overall Comfort | Week 2 | 8.3 Units on a scale | Standard Deviation 1.5 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Overall Comfort | Week 1 | 8.1 Units on a scale | Standard Deviation 1.7 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Overall Comfort | Month 1 | 8.4 Units on a scale | Standard Deviation 1.4 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Overall Comfort | Month 2 | 8.2 Units on a scale | Standard Deviation 1.5 |
| Focus® DAILIES® Toric | Subjective Rating of Overall Comfort | Month 1 | 8.8 Units on a scale | Standard Deviation 1.1 |
| Focus® DAILIES® Toric | Subjective Rating of Overall Comfort | Month 2 | 8.7 Units on a scale | Standard Deviation 1.2 |
| Focus® DAILIES® Toric | Subjective Rating of Overall Comfort | Month 3 | 8.7 Units on a scale | Standard Deviation 1.3 |
| Focus® DAILIES® Toric | Subjective Rating of Overall Comfort | Week 1 | 8.7 Units on a scale | Standard Deviation 1.1 |
| Focus® DAILIES® Toric | Subjective Rating of Overall Comfort | Week 2 | 8.7 Units on a scale | Standard Deviation 1.3 |
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.
Time frame: Up to Month 3
Population: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Overall Handling | Week 1 | 8.8 Units on a scale | Standard Deviation 1.4 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Overall Handling | Month 1 | 9.0 Units on a scale | Standard Deviation 1.2 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Overall Handling | Dispense | 9.0 Units on a scale | Standard Deviation 1.2 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Overall Handling | Month 2 | 9.0 Units on a scale | Standard Deviation 1.2 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Overall Handling | Week 2 | 9.0 Units on a scale | Standard Deviation 0.9 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Overall Handling | Month 3 | 9.0 Units on a scale | Standard Deviation 1.1 |
| Focus® DAILIES® Toric | Subjective Rating of Overall Handling | Month 3 | 9.1 Units on a scale | Standard Deviation 1.1 |
| Focus® DAILIES® Toric | Subjective Rating of Overall Handling | Dispense | 9.0 Units on a scale | Standard Deviation 1.7 |
| Focus® DAILIES® Toric | Subjective Rating of Overall Handling | Week 1 | 8.7 Units on a scale | Standard Deviation 1.2 |
| Focus® DAILIES® Toric | Subjective Rating of Overall Handling | Week 2 | 8.8 Units on a scale | Standard Deviation 1.2 |
| Focus® DAILIES® Toric | Subjective Rating of Overall Handling | Month 1 | 8.9 Units on a scale | Standard Deviation 1.1 |
| Focus® DAILIES® Toric | Subjective Rating of Overall Handling | Month 2 | 9.0 Units on a scale | Standard Deviation 1.1 |
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: All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Overall Vision | Week 2 | 8.8 Units on a scale | Standard Deviation 1.4 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Overall Vision | Dispense | 8.6 Units on a scale | Standard Deviation 1.4 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Overall Vision | Week 1 | 8.7 Units on a scale | Standard Deviation 1.6 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Overall Vision | Month 1 | 8.7 Units on a scale | Standard Deviation 1.3 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Overall Vision | Month 2 | 8.7 Units on a scale | Standard Deviation 1.4 |
| DAILIES® AquaComfort Plus® Toric | Subjective Rating of Overall Vision | Month 3 | 8.9 Units on a scale | Standard Deviation 1.2 |
| Focus® DAILIES® Toric | Subjective Rating of Overall Vision | Month 2 | 8.9 Units on a scale | Standard Deviation 0.9 |
| Focus® DAILIES® Toric | Subjective Rating of Overall Vision | Week 2 | 8.9 Units on a scale | Standard Deviation 1 |
| Focus® DAILIES® Toric | Subjective Rating of Overall Vision | Month 1 | 8.9 Units on a scale | Standard Deviation 0.9 |
| Focus® DAILIES® Toric | Subjective Rating of Overall Vision | Dispense | 8.9 Units on a scale | Standard Deviation 1.2 |
| Focus® DAILIES® Toric | Subjective Rating of Overall Vision | Month 3 | 8.8 Units on a scale | Standard Deviation 1.3 |
| Focus® DAILIES® Toric | Subjective Rating of Overall Vision | Week 1 | 8.8 Units on a scale | Standard Deviation 1.1 |