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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.
Eligible participants were randomized 2:1 to wear either DAILIES® AquaComfort Plus® Toric or Focus® DAILIES® Toric.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAILIES® AquaComfort Plus® Toric | Experimental | Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months |
|
| Focus® DAILIES® Toric | Active Comparator | Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelfilcon A toric contact lenses (with comfort additives) | Device |
| ||
| Nelfilcon A toric contact lenses |
| 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 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. | Up to Month 3 |
| Subjective Rating of End of Day Comfort |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Fahmy, OD | Alcon Research | Study Director |
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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 were recruited from ten US study centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Focus® DAILIES® Toric | Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This reporting group includes all enrolled and dispensed participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Focus® DAILIES® Toric |
| Units | Counts |
|---|---|
| Participants |
|
| 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. | All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses. | Posted | Number | Percentage of eyes | Up to Month 3 |
|
Adverse events were collected from the time of consent and reported for the duration of the study.
This reporting group includes all enrolled and dispensed 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 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Fahmy, OD, Clinical Lead | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Device |
|
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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. |
| Up to Month 3 |
| 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. | Up to Month 3 |
| 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. | Up to Month 3 |
| 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 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 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. | 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 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. | Up to Month 3 |
| 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. | 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 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. | Up to Month 3 |
| 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. | Up to Month 3 |
| Noncompliance |
|
Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months |
|
|
| 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. | All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | Up to Month 3 |
|
|
|
| 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. | All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | Up to Month 3 |
|
|
|
| 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. | All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | Up to Month 3 |
|
|
|
| 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. | All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | Up to Month 3 |
|
|
|
| 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. | All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses. | 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. | All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses. | Posted | Mean | Standard Deviation | Units on a scale | Up to Month 3 |
|
|
|
| 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. | All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses. | Posted | Number | Percentage of lenses | Up to Month 3 |
|
|
|
| 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. | All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses. | Posted | Number | Percentage of lenses | Up to Month 3 |
|
|
|
| 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. | All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses. | Posted | Number | Percentage of lenses | Up to Month 3 |
|
|
|
| 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. | All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses. | Posted | Number | Percentage of lenses | Up to Month 3 |
|
|
|
| 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. | All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses. | Posted | Number | Percentage of lenses | Up to Month 3 |
|
|
|
| 0 |
| 95 |
| 0 |
| 95 |
| EG001 | Focus® DAILIES® Toric | Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months | 0 | 49 | 0 | 49 |
For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.
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