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The objective of the study was to compare the clinical performance of the two contact lenses when used in combination with three care systems.
This was a randomized, open-label, crossover study, controlled by cross-comparison. Subjects were randomized to wear each lens and solution combination for a month in random sequence; that is for a total of six months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comfilcon A with Hy-Care Multi-purpose solution | Experimental | Subjects were randomized to wear each lens and solution combination for a month. |
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| comfilcon A with All in One Light Multi-purpose solution | Experimental | Subjects were randomized to wear each lens and solution combination for a month. |
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| comfilcon A with Refine One Step Hydrogen Peroxide Solution | Experimental | Subjects were randomized to wear each lens and solution combination for a month. |
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| fanfilcon A with Hy-Care Multi-purpose solution | Active Comparator | Subjects were randomized to wear each lens and solution combination for a month. |
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| fanfilcon A with All in One Light multi-purpose solution | Active Comparator | Subjects were randomized to wear each lens and solution combination for a month. |
|
| fanfilcon A with Refine One Step Hydrogen Peroxide Solution |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comfilcon A | Device | Subjects were randomized to wear each lens and solution combination for a month. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort | Overall Comfort will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt). | One Month |
| Comfort on Insertion | Comfort on insertion will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt). | One Month |
| Comfort Before Removal | Comfort before removal will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt). | One Month |
| Measure | Description | Time Frame |
|---|---|---|
| Vision | Vision will be assessed using vertical visual analogue scales (0-100) (0 - Unacceptable. Lens cannot be worn, 20 - Very poor. Marked and unacceptable reduction, 40 - Poor. Noticeable but acceptable reduction, 60 - Good. Occasional but acceptable reduction, 80 - Very good. Just noticeable and very occasional reduction, 100 -Excellent. Unaware of any visual loss) | One Month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Morgan, MCOptom FAAO FBCLA | Eurolens Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Manchester | Manchester | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Comfilcon A With All in One Light |
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| Comfilcon A With Hy-Care |
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| Comfilcon A With Refine One Step |
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| Fanfilcon A With All in One Light |
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| Fanfilcon A With Hy-Care |
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| Fanfilcon A With Refine One Step |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Subjects were randomized to use each lens and solution combination for a month in random sequence; that is for a total of six months. Lenses (comfilcon A and fanfilcon A), Lens care solutions(Hy-Care, All in One Light and Refine One Step). |
| 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, Categorical | Count of 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 | Overall Comfort | Overall Comfort will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt). | Posted | Mean | Standard Deviation | units on a scale | One Month |
|
Subjects were randomized to wear each lens and lens solution combination for a month at random sequence for a total of 6 months. Contact lenses (comfilcon A, fanficon A) Lens Solution (Hy-Care, All in One Light and Refine One Step).
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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 | Comfilcon A With Hy-Care Multi-purpose Solution | Subjects were randomized to wear comfilcon A with Hy-Care Multi-purpose solutionfor a month. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal Infiltrate | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal Infiltrate | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose Vega, OD, MSc, FAAO | CooperVision, Inc | 925-621-3761 | JVega2@coopervision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2019 | Apr 20, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Subjects will use each lens and solution combination for a month in random sequence for a total of six months.
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| Active Comparator |
Subjects were randomized to wear each lens and solution combination for a month. |
|
| fanfilcon A | Device | Subjects were randomized to wear each lens and solution combination for a month. |
|
| Variable Vision | Variable Vision will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of variation in vision, 20 - Very poor. Excessive variation in vision which definitely affects wearing my contact lenses, 40 - Poor. A level of variation in vision which is sometimes annoying, Good. Acceptable level of variation in vision, 80 - Very good. Very occasional or very slight sensation of variation in vision, 100 - Excellent. No variation in vision). | One Month |
| Vision at Night | Vision at night will be assessed using vertical visual analogue scales (0-100) (0 - Unacceptable. Lens cannot be worn, 20 - Very poor. Marked and unacceptable reduction, 40 - Poor. Noticeable but acceptable reduction, 60 - Good. Occasional but acceptable reduction, 80 - Very good. Just noticeable and very occasional reduction, 100 -Excellent. Unaware of any visual loss) | One Month |
| Dryness | Dryness will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of dryness, 20 - Very poor. Dryness which definitely affects wearing my contact lenses, 40 - Poor. A level of dryness which is sometimes annoying, 60 - Good. Acceptable level of dryness, 80 - Very good. Very occasional or very slight sensation of dryness only, 100 - Excellent. I have no sensation of dryness whatsoever). | One Month |
| Ocular Redness | Ocular Redness will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of redness, 20 - Very poor. Excessive redness which definitely affects wearing my contact lenses, 40 - Poor. A level of redness which is sometimes annoying, 60 - Good. Acceptable level of redness, 80 - Very good. Very occasional or very slight awareness of redness, 100 - Excellent. No redness). | One Month |
| Burning/Stinging | Burning/Stinging will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of burning or stinging, 20 - Very poor. Excessive burning or stinging which definitely affects wearing my contact lenses, 40 - Poor. A level of burning or stinging which is sometimes annoying, 60 - Good. Acceptable level of burning or stinging, 80 - Very good. Very occasional or very slight sensation of burning or stinging, 100 - Excellent. No burning or stinging). | One Month |
| Ease of Lens Insertion | Ease of lens insertion will be assessed using vertical visual analogue scales 0-100. (0 - Unmanageable. Lenses impossible to insert, 20 - Very poor. Difficult and occasional unsuccessful insertion, 40 - Poor. Difficult with very occasional unsuccessful insertion, 60 - Good. Some problems but lens insertion usually successful, 80 - Very good. Occasional difficulty with lens insertion, 100 - Excellent. No problems with lens insertion). | One Month |
| Ease of Lens Removal | Ease of lens removal will be assessed using vertical visual analogue scales (0-100) ( 0 - Unmanageable. Lenses impossible to remove, 20 - Very poor. Difficult and occasional unsuccessful removal, 40 - Poor. Difficult with very occasional unsuccessful removal, 60 - Good. Some problems but lens removal usually successful, 80 - Very good. Occasional difficulty with lens removal, 100 - Excellent. No problems with lens removal). | One Month |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG002 | Comfilcon A With Refine One Step Hydrogen Peroxide Solution | Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month. |
| OG003 | Fanfilcon A With All in One Light Multi-purpose Solution | Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solution for a month. |
| OG004 | Fanfilcon A With Hy-Care Multi-purpose Solution | Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month. |
| OG005 | Fanfilcon A With Refine One Step Hydrogen Peroxide Solution | Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solution for a month. |
|
|
| Primary | Comfort on Insertion | Comfort on insertion will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt). | Posted | Mean | Standard Deviation | units on a scale | One Month |
|
|
|
| Primary | Comfort Before Removal | Comfort before removal will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt). | Posted | Mean | Standard Deviation | units on a scale | One Month |
|
|
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| Secondary | Vision | Vision will be assessed using vertical visual analogue scales (0-100) (0 - Unacceptable. Lens cannot be worn, 20 - Very poor. Marked and unacceptable reduction, 40 - Poor. Noticeable but acceptable reduction, 60 - Good. Occasional but acceptable reduction, 80 - Very good. Just noticeable and very occasional reduction, 100 -Excellent. Unaware of any visual loss) | One subject was excluded from the analysis from fanfilcon A with All in One Light multipurpose solution and fanfilcon A with Refine One Step Hydrogen Peroxide Solution. | Posted | Mean | Standard Deviation | units on a scale | One Month |
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| Secondary | Variable Vision | Variable Vision will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of variation in vision, 20 - Very poor. Excessive variation in vision which definitely affects wearing my contact lenses, 40 - Poor. A level of variation in vision which is sometimes annoying, Good. Acceptable level of variation in vision, 80 - Very good. Very occasional or very slight sensation of variation in vision, 100 - Excellent. No variation in vision). | One subject was excluded from the analysis from fanfilcon A with All in One Light multipurpose solution and fanfilcon A with Refine One Step Hydrogen Peroxide Solution. | Posted | Mean | Standard Deviation | units on a scale | One Month |
|
|
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| Secondary | Vision at Night | Vision at night will be assessed using vertical visual analogue scales (0-100) (0 - Unacceptable. Lens cannot be worn, 20 - Very poor. Marked and unacceptable reduction, 40 - Poor. Noticeable but acceptable reduction, 60 - Good. Occasional but acceptable reduction, 80 - Very good. Just noticeable and very occasional reduction, 100 -Excellent. Unaware of any visual loss) | One subject was excluded from the analysis from fanfilcon A with All in One Light multipurpose solution and fanfilcon A with Refine One Step Hydrogen Peroxide Solution. | Posted | Mean | Standard Deviation | units on a scale | One Month |
|
|
|
| Secondary | Dryness | Dryness will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of dryness, 20 - Very poor. Dryness which definitely affects wearing my contact lenses, 40 - Poor. A level of dryness which is sometimes annoying, 60 - Good. Acceptable level of dryness, 80 - Very good. Very occasional or very slight sensation of dryness only, 100 - Excellent. I have no sensation of dryness whatsoever). | Posted | Mean | Standard Deviation | units on a scale | One Month |
|
|
|
| Secondary | Ocular Redness | Ocular Redness will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of redness, 20 - Very poor. Excessive redness which definitely affects wearing my contact lenses, 40 - Poor. A level of redness which is sometimes annoying, 60 - Good. Acceptable level of redness, 80 - Very good. Very occasional or very slight awareness of redness, 100 - Excellent. No redness). | Posted | Mean | Standard Deviation | units on a scale | One Month |
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| Secondary | Burning/Stinging | Burning/Stinging will be assessed using vertical visual analogue scales (0-100) (0 - Extremely poor. Intolerable levels of burning or stinging, 20 - Very poor. Excessive burning or stinging which definitely affects wearing my contact lenses, 40 - Poor. A level of burning or stinging which is sometimes annoying, 60 - Good. Acceptable level of burning or stinging, 80 - Very good. Very occasional or very slight sensation of burning or stinging, 100 - Excellent. No burning or stinging). | Posted | Mean | Standard Deviation | units on a scale | One Month |
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| Secondary | Ease of Lens Insertion | Ease of lens insertion will be assessed using vertical visual analogue scales 0-100. (0 - Unmanageable. Lenses impossible to insert, 20 - Very poor. Difficult and occasional unsuccessful insertion, 40 - Poor. Difficult with very occasional unsuccessful insertion, 60 - Good. Some problems but lens insertion usually successful, 80 - Very good. Occasional difficulty with lens insertion, 100 - Excellent. No problems with lens insertion). | Posted | Mean | Standard Deviation | units on a scale | One Month |
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| Secondary | Ease of Lens Removal | Ease of lens removal will be assessed using vertical visual analogue scales (0-100) ( 0 - Unmanageable. Lenses impossible to remove, 20 - Very poor. Difficult and occasional unsuccessful removal, 40 - Poor. Difficult with very occasional unsuccessful removal, 60 - Good. Some problems but lens removal usually successful, 80 - Very good. Occasional difficulty with lens removal, 100 - Excellent. No problems with lens removal). | Posted | Mean | Standard Deviation | units on a scale | One Month |
|
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|
| 0 |
| 30 |
| 1 |
| 30 |
| 2 |
| 30 |
| EG001 | Comfilcon A With All in One Light Multi-purpose Solution | Subjects were randomized to wear comfilcon A with All in One Light Multi-purpose solution for a month. | 0 | 28 | 0 | 28 | 0 | 28 |
| EG002 | Comfilcon A With Refine One Step Hydrogen Peroxide Solution | Subjects were randomized to wear comfilcon A with Refine One Step Hydrogen Peroxide Solution for a month. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG003 | Fanfilcon A With Hy-Care Multi-purpose Solution | Subjects were randomized to wear fanfilcon A with Hy-Care Multi-purpose solution for a month. | 0 | 28 | 0 | 28 | 2 | 28 |
| EG004 | Fanfilcon A With All in One Light Multi-purpose Solution | Subjects were randomized to wear fanfilcon A with All in One Light multi-purpose solutionfor a month. | 0 | 28 | 1 | 28 | 1 | 28 |
| EG005 | Fanfilcon A With Refine One Step Hydrogen Peroxide Solution | Subjects were randomized to wear fanfilcon A with Refine One Step Hydrogen Peroxide Solutionfor a month. | 0 | 29 | 0 | 29 | 2 | 29 |
| Ocular Redness | Eye disorders | Systematic Assessment |
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| Eye Irritation | Eye disorders | Systematic Assessment |
|
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