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The purpose of this study is to evaluate worn AIR OPTIX® plus HYDRAGLYDE® (AOHG) lenses cleaned and disinfected with HYDRAGLYDE® containing lens solutions compared to each of the control habitual silicone hydrogel (SiHy) lenses cleaned and disinfected with habitual multi-purpose solution (MPS) for cholesterol uptake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AOHG | Experimental | Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with either a hydrogen peroxide-based contact lens solution with added wetting agent or a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent, as randomized |
|
| Habitual | Active Comparator | Habitual silicone hydrogel contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B contact lenses with added wetting agent | Device | Silicone hydrogel contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ex Vivo Total Cholesterol Uptake at Day 30 | The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance. | Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Manager, Global Med Affairs, GCRA | Alcon, A Novartis Division | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Birmingham | Alabama | 35233 | United States | ||
| Alcon Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32769842 | Derived | Shows A, Redfern RL, Sickenberger W, Fogt JS, Schulze M, Lievens C, Szczotka-Flynn L, Schwarz S, Tichenor AA, Marx S, Lemp-Hull JM. Lipid Analysis on Block Copolymer-containing Packaging Solution and Lens Care Regimens: A Randomized Clinical Trial. Optom Vis Sci. 2020 Aug;97(8):565-572. doi: 10.1097/OPX.0000000000001553. |
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Of the 323 enrolled, 66 subjects exited as screen failures prior to randomization. An additional 5 subjects were randomized but discontinued prior to treatment. This reporting group includes all randomized and exposed subjects (252). Subject distribution in As Randomized and As Treatment differs due to 3 subjects with lens/solution misallocations.
Subjects were recruited from 8 study centers located in the United States (5), Germany (2), and Canada (1).
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| ID | Title | Description |
|---|---|---|
| FG000 | AOHG/CCP | Lotrafilcon B contact lenses with added wetting agent, worn bilaterally (in both eyes) for 30 days in a daily wear modality and cared for with a hydrogen peroxide-based contact lens solution with added wetting agent |
| FG001 | AOHG/OFPM |
| 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 |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 19, 2016 | Jul 20, 2018 |
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| Samfilcon A contact lenses | Device | Habitual silicone hydrogel contact lenses |
|
|
| POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent | Device | Multi-purpose disinfecting solution for contact lens care |
|
|
| Hydrogen peroxide-based contact lens solution with added wetting agent | Device | Solution for contact lens cleaning and disinfecting |
|
|
| Senofilcon C contact lenses | Device | Habitual silicone hydrogel contact lenses |
|
|
| Senofilcon A contact lenses | Device | Habitual silicone hydrogel contact lenses with a replacement pair issued after 2 weeks |
|
|
| Comfilcon A contact lenses | Device | Habitual silicone hydrogel contact lenses |
|
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| Habitual Multi-Purpose Solution (HMPS) | Device | Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions |
|
| Cleveland |
| Ohio |
| 44106 |
| United States |
| Alcon Investigative Site | Columbus | Ohio | 43210 | United States |
| Alcon Investigative Site | Memphis | Tennessee | 38104 | United States |
| Alcon Investigative Site | Houston | Texas | 77204 | United States |
| Alcon Investigative Site | Waterloo | Ontario | N2L3G1 | Canada |
| Alcon Investigative Site | Hildesheim | 31134 | Germany |
| Alcon Investigative Site | Jena | 07745 | Germany |
Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent |
| FG002 | Biofinity/HMPS | Habitual silicone hydrogel (SiHy) contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual multi-purpose solution (MPS) |
| FG003 | Vita/HMPS | Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS |
| FG004 | Ultra/HMPS | Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS |
| FG005 | Oasys/HMPS | Habitual SiHy contact lenses worn bilaterally for 30 days (replaced after 15 days) in a daily wear modality and cared for with participant's habitual MPS |
|
| Treated | Randomized and treated, as treated |
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| COMPLETED |
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| NOT COMPLETED |
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This analysis population includes all randomized and exposed to a study lens on Day 1 or a study regimen (lens and lens care system (LCS)) thereafter (Full Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | AOHG/CCP | Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a hydrogen peroxide-based contact lens solution with added wetting agent |
| BG001 | AOHG/OFPM | Lotrafilcon B contact lenses with added wetting agent, worn bilaterally for 30 days in a daily wear modality and cared for with a POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent |
| BG002 | Biofinity/HMPS | Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS |
| BG003 | Vita/HMPS | Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS |
| BG004 | Ultra/HMPS | Habitual SiHy contact lenses worn bilaterally for 30 days in a daily wear modality and cared for with participant's habitual MPS |
| BG005 | Oasys/HMPS | Habitual SiHy contact lenses worn bilaterally for 30 days (replaced after 15 days) in a daily wear modality and cared for with participant's habitual MPS |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Ex Vivo Total Cholesterol Uptake at Day 30 | The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance. | Full Analysis Set with cholesterol uptake measured | Posted | Mean | Standard Deviation | μg | Day 30 |
|
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|
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Lens insertion (Day 1) through study completion, an average of 30 days
Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all subjects/eyes exposed to study lens and/or study LCS evaluated in this study as a regimen (Safety Analysis Set). "At risk" population for ocular AEs is reported in units of eyes, as treated.
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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 | AOHG/CCP Ocular | Eyes exposed to AOHG contact lenses and CCP for lens care | 0 | 116 | 0 | 116 | 0 | 116 |
| EG001 | AOHG/CCP Nonocular | Subjects exposed to AOHG contact lenses and CCP for lens care | 0 | 58 | 0 | 58 | 0 | 58 |
| EG002 | AOHG/OFPM Ocular | Eyes exposed to AOHG contact lenses and OFPM for lens care | 0 | 130 | 0 | 130 | 0 | 130 |
| EG003 | AOHG/OFPM Nonocular | Subjects exposed to AOHG contact lenses and OFPM for lens care | 0 | 65 | 0 | 65 | 0 | 65 |
| EG004 | Habitual SiHy/MPS Ocular | Eyes exposed to habitual SiHy contact lenses and habitual MPS for lens care | 0 | 258 | 0 | 258 | 0 | 258 |
| EG005 | Habitual SiHy/MPS Nonocular | Subjects exposed to habitual SiHy contact lenses and habitual MPS for lens care | 0 | 129 | 0 | 129 | 0 | 129 |
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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 | |
|---|---|---|---|---|
| Senior Clinical Project Lead, GCRA - Clin Dev Vision Care | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 24, 2017 | Jul 20, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
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| Superiority |
| General Linear Model | <0.0001 | Superiority |
| General Linear Model | <0.0001 | Superiority |
| General Linear Model | <0.0001 | Superiority |
| General Linear Model | <0.0001 | Superiority |
| General Linear Model | <0.0001 | Superiority |
| General Linear Model | <0.0001 | Superiority |