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The objective of this study is to compare the short-term clinical response to all combinations of two lens types: fanfilcon A and comfilcon A with two care systems: Hy-Care and Lite. The primary variables of interest are short-term biomicroscopy signs. Other variables of interest include subjective response and visual performance.
Subjects were randomized to wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in the Hy-Care contact lens solution and Lite contact lens solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hy-Care Contact Lens Solution | Active Comparator | Each subject will wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in the Hy-Care contact lens solution. |
|
| Lite Contact Lens Solution | Active Comparator | Each subject will wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in the Lite contact lens solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hy-Care Contact Lens Solution | Device | Hy-Care Contact Lens Solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Biomicroscopy - Conjuctival Hyperaemia | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Baseline (before lens insertion) |
| Biomicroscopy - Conjuctival Hyperaemia | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | 2 hours |
| Biomicroscopy - Limbal Hyperaemia | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Baseline (before contact lens insertion) |
| Biomicroscopy - Limbal Hyperaemia | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | 2 hours |
| Biomicroscopy - Corneal Vascularisation | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Baseline (before lens insertion) |
| Biomicroscopy - Corneal Vascularisation | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt). | Baseline 5 minutes after lens insertion |
| Comfort | Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Morgan, PhD MCOptom FAAO FBCLA | Eurolens Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research | Manchester | M13 9PL | United Kingdom |
This was a randomised, double-masked, contralateral, cross-over study in which subjects were randomized to wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in a lens care product Lite or Hy-Care.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hy-Care - Comfilcon A Then Lite - Fanfilcon A on Right Eye | Subjects were randomized to wear comfilcon A lens soaked overnight in the Hy-Care solution on the right eye for two hours then wear fanfilcon A lens soaked overnight in the Lite Solution on right eye for 2 hours. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens |
| FG001 | Hy-Care - Fanfilcon A Then Lite - Comilcon A on Left Eye | Subjects were randomized to wear fanfilcon A lens soaked overnight in the Hy-Care solution on the left eye for two hours then wear comfilcon A lens soaked overnight in the Lite Solution on left eye for 2 hours. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens |
| FG002 | Hy-Care - Fanfilcon A Then Lite - Comfilcon A on Right Eye | Subjects were randomized to wear fanfilcon A lens soaked overnight in the Hy-Care solution on the right eye for two hours then wear comfilcon A lens soaked overnight in the Lite Solution on right eye for 2 hours. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens |
| FG003 | Hy-Care - Comfilcon A Then Lite - Fanfilcon A on Left Eye | Subjects were randomized to wear comfilcon A lens soaked overnight in the Hy-Care solution on the left eye for two hours then wear fanfilcon A lens soaked overnight in the Lite Solution on left eye for 2 hours. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens |
| FG004 | Lite - Comfilcon A Then Hy-Care - Fanfilcon A on Right Eye | Subjects were randomized to wear comfilcon A lens soaked overnight in the Lite solution on the right eye for two hours then wear fanfilcon A lens soaked overnight in the Hy-Care Solution on right eye for 2 hours. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens |
| FG005 | Lite - Fanfilcon A Then Hy-Care - Comfilcon A on Left Eye | Subjects were randomized to wear fanfilcon A lens soaked overnight in the Lite solution on the left eye for two hours then wear comfilcon A lens soaked overnight in the Hy-Care Solution on left eye for 2 hours. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens |
| FG006 | Lite - Fanfilcon A Then Hy-Care - Comfilcon A on Right Eye | Subjects were randomized to wear fanfilcon A lens soaked overnight in the Lite solution on the right eye for two hours then wear comfilcon A lens soaked overnight in the Hy-Care solution on right eye for 2 hours. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens |
| FG007 | Lite - Comfilcon A Then Hy-Care - Fanfilcon A on Left Eye | Subjects were randomized to wear comfilcon A lens soaked overnight in the Lite solution on the left eye for two hours then wear fanfilcon A lens soaked overnight in the Hy-Care Solution on left eye for 2 hours. Hy-Care Contact Lens Solution: Hy-Care Contact Lens Solution Lite Contact Lens Solution: Lite Contact Lens Solution comfilcon A soft contact lens: comfilcon A soft contact lens fanfilcon A soft contact lens: fanfilcon A soft contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | Subjects were randomized to wear fanfilcon A soft contact lens in one eye and comfilcon A soft contact lens in the other eye with each lens having been soaked overnight in the Hy-Care contact lens solution and Lite contact lens solution. Contact Lens Solution: Hy-Care Contact Lens Solution Contact Lens Solution: Lite contact lens solution |
| 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 | Biomicroscopy - Conjuctival Hyperaemia | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Posted | Mean | Standard Deviation | units on a scale | Baseline (before lens insertion) | Eyes | Eyes |
|
From baseline to follow up visit for an average of 2 hours, up to maximum of 14 days.
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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 | Hy-Care Contact Lens Solution - Comfilcon A | Contact Lens Solution: Hy-Care Contact Lens Solution Contact lens: comfilcon A soft contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, O.D, MSc., FAAO | CooperVision. Inc | 9256213761 | javega@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 18, 2018 | Jan 21, 2020 | Prot_SAP_000.pdf |
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This is a double-masked, randomized, contralateral, crossover study design. Lenses are worn as an unmatched pair.
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The first solution, the randomisation determines that the right lens will wear the fanfilcon A lens and the left eye will wear the comfilcon A lens for two hours of wear, with a two-day 'wash-out' period and the laterality of the lenses will be swapped for the second solution for two hours of wear. Lenses will be provided in lens cases which do not detail lens or care system information.
| Lite Contact Lens Solution |
| Device |
Lite Contact Lens Solution |
|
| fanfilcon A soft contact lens | Device | fanfilcon A soft contact lens |
|
| comfilcon A soft contact lens | Device | comfilcon A soft contact lens |
|
| 2 hours |
| Biomicroscopy - Microcysts | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Baseline (before lens insertion) |
| Biomicroscopy - Microcysts | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | 2 hours |
| Biomicroscopy - Oedema | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Baseline (before lens insertion) |
| Biomicroscopy - Oedema | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | 2 hours |
| Biomicroscopy - Conjunctival Staining | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Baseline (before lens insertion) |
| Biomicroscopy - Conjunctival Staining | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | 2 hours |
| Biomicroscopy - Papillary Conjunctivitis | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Baseline (before lens insertion) |
| Biomicroscopy - Papillary Conjunctivitis | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | 2 hours |
| 2 hours |
| Dryness | Subjective ratings of dryness for each pair of lenses measured only at follow up (scale: 0-100; 0=Intolerable levels of dryness, 100=No sensation of dryness). | 2 hours |
| Overall Score | Subjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall). | Baseline 5 minutes after lens insertion |
| Overall Score | Subjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall). | 2 hours |
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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 | Lite Contact Lens Solution - Comfilcon A | Each subject will wear comfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens |
| OG003 | Lite Contact Lens Solution - Fanfilcon A | Each subject will wear fanfilcon A soft contact lens in one eye with lens having been soaked overnight in the Lite contact lens solution. Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens |
|
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| Primary | Biomicroscopy - Conjuctival Hyperaemia | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Posted | Mean | Standard Deviation | units on a scale | 2 hours | Eyes | Eyes |
|
|
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| Primary | Biomicroscopy - Limbal Hyperaemia | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Posted | Mean | Standard Deviation | units on a scale | Baseline (before contact lens insertion) | Eyes | Eyes |
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|
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| Primary | Biomicroscopy - Limbal Hyperaemia | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Posted | Mean | Standard Deviation | units on a scale | 2 hours | Eyes | Eyes |
|
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| Primary | Biomicroscopy - Corneal Vascularisation | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Posted | Mean | Standard Deviation | units on a scale | Baseline (before lens insertion) | Eyes | Eyes |
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|
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| Primary | Biomicroscopy - Corneal Vascularisation | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Posted | Mean | Standard Deviation | units on a scale | 2 hours | Eyes | Eyes |
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| Primary | Biomicroscopy - Microcysts | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Posted | Mean | Standard Deviation | units on a scale | Baseline (before lens insertion) | Eyes | Eyes |
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| Primary | Biomicroscopy - Microcysts | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Posted | Mean | Standard Deviation | units on a scale | 2 hours | Eyes | Eyes |
|
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| Primary | Biomicroscopy - Oedema | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Posted | Mean | Standard Deviation | units on a scale | Baseline (before lens insertion) | Eyes | Eyes |
|
|
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| Primary | Biomicroscopy - Oedema | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Posted | Mean | Standard Deviation | units on a scale | 2 hours | Eyes | Eyes |
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| Primary | Biomicroscopy - Conjunctival Staining | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Posted | Mean | Standard Deviation | units on a scale | Baseline (before lens insertion) | Eyes | Eyes |
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| Primary | Biomicroscopy - Conjunctival Staining | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Posted | Mean | Standard Deviation | units on a scale | 2 hours | Eyes | Eyes |
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| Primary | Biomicroscopy - Papillary Conjunctivitis | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Posted | Mean | Standard Deviation | units on a scale | Baseline (before lens insertion) | Eyes | Eyes |
|
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|
| Primary | Biomicroscopy - Papillary Conjunctivitis | Ocular physiology assessment of fanfilcon A and comfilcon A contact lenses with lens care products Lite and Hy-Care biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe). | Posted | Mean | Standard Deviation | units on a scale | 2 hours | Eyes | Eyes |
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| Secondary | Comfort | Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt). | Posted | Mean | Standard Deviation | units on a scale | Baseline 5 minutes after lens insertion | Eyes | Eyes |
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| Secondary | Comfort | Subjective ratings of comfort for each pair of lenses (scale: 0-100; 0=Cannot be tolerated,100=Cannot be felt). | Posted | Mean | Standard Deviation | units on a scale | 2 hours | Eyes | Eyes |
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| Secondary | Dryness | Subjective ratings of dryness for each pair of lenses measured only at follow up (scale: 0-100; 0=Intolerable levels of dryness, 100=No sensation of dryness). | Posted | Mean | Standard Deviation | units on a scale | 2 hours | Eyes | Eyes |
|
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|
| Secondary | Overall Score | Subjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall). | Posted | Mean | Standard Deviation | units on a scale | Baseline 5 minutes after lens insertion | Eyes | Eyes |
|
|
|
| Secondary | Overall Score | Subjective ratings of overall score for each pair of lenses (scale: 0-100; 0=Cannot use lenses, 100=Highly impressed with lenses overall). | Posted | Mean | Standard Deviation | units on a scale | 2 hours | Eyes | Eyes |
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| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Hy-Care Contact Lens Solution - Fanfilcon A | Contact Lens Solution: Hy-Care Contact Lens Solution contact lens: fanfilcon A soft contact lens | 0 | 28 | 0 | 28 | 0 | 28 |
| EG002 | Lite Contact Lens Solution - Comfilcon A | Contact Lens Solution: Lite Contact Lens Solution Contact lens: comfilcon A soft contact lens | 0 | 28 | 0 | 28 | 0 | 28 |
| EG003 | Lite Contact Lens Solution - Fanfilcon A | Contact Lens Solution: Lite contact Lens Solution Contact lens: fanfilcon A soft contact lens | 0 | 28 | 0 | 28 | 0 | 28 |
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