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The purpose of this study is to compare an alternative fitting guide to a current fitting guide for optimizing contact lens parameters and determining contact lens prescription.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AOA MF | Experimental | Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 10 ± 3 days |
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| DACP MF | Experimental | Nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days |
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| DT1 MF | Experimental | Delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B multifocal contact lenses | Device | Contact lenses for near, intermediate, and distance correction worn on a daily wear basis and cared for with participant's habitual lens care solution |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Number of Trial Lenses Needed to Fit Each Eye | The Investigator used a multi-focal contact lens fitting guide to determine which study lens to fit | VIsit 1/Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Manager, Vision Care | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Phoenix | Arizona | 85032 | United States | ||
| Alcon Investigative Site |
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Of the 188 enrolled subjects, 6 were exited prior to trial fit. This reporting group includes all subjects randomized and trial fit, as randomized (182). Safety Analysis Set is reported as exposed.
Subjects were recruited from 20 investigational sites located in the United States (14), United Kingdom (3), and Canada (3).
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| ID | Title | Description |
|---|---|---|
| FG000 | AOA MF - Alternative | Bilaterally (in both eyes) fitted using alternative fitting guide; lotrafilcon B multifocal contact lenses worn bilaterally for 10 ± 3 days |
| FG001 | DACP MF - Alternative |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 7, 2017 | Jul 3, 2018 |
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Subjects are unmasked to the study lenses that are dispensed, but will be masked to the fitting guides used to fit each eye.
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| Nelfilcon A multifocal contact lenses | Device | Contact lenses for near, intermediate, and distance correction worn on a daily disposable basis (removed every night and discarded) with a new pair of study lenses every morning |
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| Delefilcon A multifocal contact lenses | Device | Contact lenses for near, intermediate, and distance correction worn on a daily disposable basis (removed every night and discarded) with a new pair of study lenses every morning |
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| San Diego |
| California |
| 92123 |
| United States |
| Alcon Investigative Site | Pensacola | Florida | 32503 | United States |
| Alcon Investigative Site | Tallahassee | Florida | 32308 | United States |
| Alcon Investigative Site | Pittsburg | Kansas | 66762 | United States |
| Alcon Investigative Site | Shawnee Mission | Kansas | 66204 | United States |
| Alcon Investigative Site | Ann Arbor | Michigan | 48105 | United States |
| Alcon Investigative Site | Eden Prairie | Minnesota | 55344 | United States |
| Alcon Investigative Site | Medina | Minnesota | 55340 | United States |
| Alcon Investigative Site | Raytown | Missouri | 64133 | United States |
| Alcon Investigative Site | Powell | Ohio | 43065 | United States |
| Alcon Investigative Site | Warwick | Rhode Island | 02888 | United States |
| Alcon Investigative Site | Memphis | Tennessee | 38104 | United States |
| Alcon Investigative Site | Memphis | Tennessee | 38119 | United States |
| Alcon Investigative Site | Burnaby | British Columbia | V5E 1G3 | Canada |
| Alcon Investigative Site | Toronto | Ontario | M2N 3A4 | Canada |
| Alcon Investigative Site | Toronto | M2J2Z1 | Canada |
| Alcon Investigative Site | Coventry | CV49PQ | United Kingdom |
| Alcon Investigative Site | Hereford | HR1 2PR | United Kingdom |
| Alcon Investigative Site | Monmouth | NP25 3PS | United Kingdom |
Bilaterally fitted using alternative fitting guide; nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days
| FG002 | DT1 MF - Alternative | Bilaterally fitted using alternative fitting guide; delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days |
| FG003 | AOA MF - Current | Bilaterally fitted using current fitting guide; lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 10 ± 3 days |
| FG004 | DACP MF - Current | Bilaterally fitted using current fitting guide; nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days |
| FG005 | DT1 MF - Current | Bilaterally fitted using current fitting guide; delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days |
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| Safety Analysis Set | All subjects/eyes exposed to study lenses, except those used for trial fit at Visit 1, as exposed |
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| COMPLETED | Completed, as randomized |
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| NOT COMPLETED |
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Safety Analysis Set. Baseline data analyzed based on study lens.
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| ID | Title | Description |
|---|---|---|
| BG000 | AOA MF | Lotrafilcon B multifocal contact lenses worn bilaterally for 10 ± 3 days |
| BG001 | DACP MF | Nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days |
| BG002 | DT1 MF | Delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days |
| BG003 | Total | Total of all reporting groups |
| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Mean Number of Trial Lenses Needed to Fit Each Eye | The Investigator used a multi-focal contact lens fitting guide to determine which study lens to fit | This analysis population includes all subjects randomized or assigned to study lenses as applicable, and exposed to study lenses including trial fit at Visit 1 (Full Analysis Set). | Posted | Mean | Standard Deviation | lenses | VIsit 1/Day 1 | Eyes | Eyes |
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Screening/Fitting through study completion, a maximum of 33 days.
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set, as exposed, which is different than "as randomized" due to subjects not following the assigned randomization. "At risk" population for ocular AEs is reported in units of eyes.
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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 | AOA MF Ocular | Eyes exposed to AIR OPTIX AQUA® Multifocal (AOA MF) contact lenses | 0 | 126 | 0 | 126 | 0 | 126 |
| EG001 | AOA MF Nonocular | Subjects exposed to AOA MF contact lenses | 0 | 63 | 0 | 63 | 0 | 63 |
| EG002 | DACP MF Ocular | Eyes exposed to DAILIES® AquaComfort Plus® Multifocal (DACP MF) contact lenses | 0 | 110 | 0 | 110 | 0 | 110 |
| EG003 | DACP MF Nonocular | Subjects exposed to DACP MF contact lenses | 0 | 55 | 0 | 55 | 0 | 55 |
| EG004 | DT1 MF Ocular | Eyes exposed to DAILIES TOTAL1® Multifocal (DT1 MF) contact lenses | 0 | 118 | 0 | 118 | 0 | 118 |
| EG005 | DT1 MF Nonocular | Subjects exposed to DT1 MF contact lenses | 0 | 59 | 0 | 59 | 0 | 59 |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head, CDMA Vision Care Franchise | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 21, 2017 | Jul 3, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Male |
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| Black or African American |
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| American Indian or Alaska Native |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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