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The purpose of this study is to evaluate the impact of back surface molded marks (MM) applied to delefilcon A contact lenses as measured by the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® Multifocal contact lenses with molded marks (DT1 MF MM) and current DAILIES TOTAL1® Multifocal contact lenses (DT1 MF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DT1 MF MM | Experimental | Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally (in both eyes) for 9 hours |
|
| DT1 MF | Active Comparator | Delefilcon A multifocal contact lenses worn bilaterally for 9 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A Multifocal Contact Lenses with Molded Mark | Device |
| ||
| Delefilcon A Multifocal Contact Lenses |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Ocular Discomfort Device-related Adverse Events (AE) | An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular discomfort device-related AE was defined as an ocular AE classified as "Related" to study device and deemed to be related to ocular discomfort. | Day 1 at Hour 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Staining | Assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Ocular staining was categorized by corneal staining, conjunctival staining, and limbal staining. Both eyes contributed to the analysis. | Day 1 at Hour 9 |
| Limbal Hyperemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Manager, CTM | Alcon, A Novartis Division | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
Of the 87 enrolled, 7 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (80).
Subjects were recruited from 5 study centers located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | DT1 MF MM | Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally (in both eyes) for 9 hours |
| FG001 | DT1 MF | Delefilcon A multifocal contact lenses worn bilaterally for 9 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This analysis population includes all subjects/eyes exposed to any study lenses (Safety Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | DT1 MF MM | Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally for 9 hours |
| BG001 | DT1 MF | Delefilcon A multifocal contact lenses worn bilaterally for 9 hours |
| 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 | Incidence of Ocular Discomfort Device-related Adverse Events (AE) | An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular discomfort device-related AE was defined as an ocular AE classified as "Related" to study device and deemed to be related to ocular discomfort. | Safety Analysis Set | Posted | Number | Events | Day 1 at Hour 9 | Eyes | Eyes |
|
Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (1 day). 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 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 initiation of study treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Lead, Clinical Affairs | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Device |
|
|
Hyperemia (excess of blood) was assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Both eyes contributed to the analysis. |
| Day 1 at Hour 9 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
|
|
| Secondary | Ocular Staining | Assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Ocular staining was categorized by corneal staining, conjunctival staining, and limbal staining. Both eyes contributed to the analysis. | Safety Analysis Set | Posted | Count of Units | Eyes | Day 1 at Hour 9 | Eyes | Eyes |
|
|
|
| Secondary | Limbal Hyperemia | Hyperemia (excess of blood) was assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Both eyes contributed to the analysis. | Safety Analysis Set | Posted | Count of Units | Eyes | Day 1 at Hour 9 | Eyes | Eyes |
|
|
|
| 0 |
| 87 |
| 0 |
| 87 |
| 0 |
| 87 |
| EG001 | DT1 MF MM | All subjects exposed to delefilcon A multifocal contact lenses with molded marks | 0 | 40 | 0 | 40 | 0 | 40 |
| EG002 | DT1 MF | All subjects exposed to delefilcon A multifocal contact lenses | 0 | 40 | 0 | 40 | 0 | 40 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Corneal Staining, Grade 2 |
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| Corneal Staining, Grade 3 |
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| Corneal Staining, Grade 4 |
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| Conjunctival Staining, Grade 0 |
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| Conjunctival Staining, Grade 1 |
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| Conjunctival Staining, Grade 2 |
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| Conjunctival Staining, Grade 3 |
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| Conjunctival Staining, Grade 4 |
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| Limbal Staining, Grade 0 |
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| Limbal Staining, Grade 1 |
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| Limbal Staining, Grade 2 |
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| Limbal Staining, Grade 3 |
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| Limbal Staining, Grade 4 |
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| Grade 2 |
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| Grade 3 |
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| Grade 4 |
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