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The purpose of this study is to evaluate DAILIES TOTAL1® Multifocal (DTl MF) contact lenses in current multifocal contact lens wearers with symptoms of end of day discomfort compared to their habitual multifocal contact lens correction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DT1 MF, then Habitual | Other | Delefilcon A multifocal contact lenses in Period 1, followed by subject's habitual multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days. |
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| Habitual, then DT1 MF | Other | Subject's habitual multifocal contact lenses in Period 1, followed by delefilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A multifocal contact lenses | Device | Multifocal contact lenses worn in a daily wear, daily disposable modality (new pair of lenses each morning) |
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| Measure | Description | Time Frame |
|---|---|---|
| Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm) | Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HC/HI VA was assessed binocularly (both eyes together) at 80 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity. | Day 14, each product |
| Measure | Description | Time Frame |
|---|---|---|
| Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score | The abbreviated CLDEQ-8 is an 8-item questionnaire used to assess comfort and dryness. Total CLDEQ-8 score ranged from 0 to 37, where a lower score represented less symptomology. | Day 14, each product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Project Manager, PLS | Alcon, A Novartis Division | Study Director |
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Of the 170 enrolled, 2 subjects were exited as screen failures prior to randomization. An additional 2 subjects were randomized in error but not exposed. This reporting group includes all randomized and exposed subjects (166).
Subjects were recruited from 11 study centers located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | DT1 MF / Habitual MF | Delefilcon A multifocal (MF) contact lenses in Period 1, followed by subject's habitual multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days. |
| FG001 | Habitual MF / DT1 MF | Subject's habitual multifocal contact lenses in Period 1, followed by delefilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, First 14 Days of Wear |
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| Period 2, Second 14 Days of Wear |
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This analysis population includes all randomized subjects who were exposed to any study lenses, except for lenses used for parameter optimization and fitting (Full Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Delefilcon A multifocal contact lenses and subject's habitual multifocal contact lenses worn bilaterally during Period 1 and Period 2 in a crossover assignment. |
| 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 | Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm) | Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HC/HI VA was assessed binocularly (both eyes together) at 80 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity. | Full Analysis Set. Number Analyzed is the number of subjects with non-missing responses. | Posted | Mean | Standard Deviation | logMAR | Day 14, each product |
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Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 44 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
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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 | Pre-treatment | All subjects who consented to participate in the study prior to exposure to study lenses dispensed for 14-day wear |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Franchise Head, Vision Care | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Habitual multifocal contact lenses | Device | Multifocal contact lenses worn per subject's habitual prescription and habitual daily wear modality |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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Subject's habitual multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2. |
|
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| Secondary | Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score | The abbreviated CLDEQ-8 is an 8-item questionnaire used to assess comfort and dryness. Total CLDEQ-8 score ranged from 0 to 37, where a lower score represented less symptomology. | Full Analysis Set. Number Analyzed is the number of subjects with non-missing responses. | Posted | Mean | Standard Deviation | units on a scale | Day 14, each product |
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| 0 |
| 170 |
| 0 |
| 170 |
| 0 |
| 170 |
| EG001 | DT1 MF | Delefilcon A multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2 | 0 | 165 | 0 | 165 | 0 | 165 |
| EG002 | Habitual MF | Subject's habitual multifocal contact lenses worn bilaterally for 14 ± 3 days in Period 1 and Period 2. | 0 | 166 | 0 | 166 | 0 | 166 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Period Two |
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| Overall |
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