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The objective of the study is to compare the overall subjective preference of filcon II 3 daily disposable silicone hyrogel contact lenses compared to etafilcon A and nelfilcon A daily disposable conventional hydrogel contact lenses.
Double-masked, randomised, controlled crossover trial. Subjects were randomized to wear one or the other of the conventional hydriogel lenses; all subjects wore the filcon II 3 lenses. The first randomly assigned lens type was worn for 3 days, with daily replacement, followed by 3 days of wear of the other lens type, with daily replacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etafilcon A lens | Active Comparator | Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types. |
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| nelfilcon A lens | Active Comparator | Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types. |
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| filcon II 3 lens | Active Comparator | Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filcon II 3 | Device | Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Lens Preference - All Study Lenses | Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair of lenses. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2). | Study Exit |
| Overall Lens Preference - Hydrogel vs. Filcon II 3 | Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2). | Study Exit |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Response for Comfort | Participant's subjective response for comfort measured at baseline and 3 day follow-up. (Continuous Comfort Scale 0-100, 0=cannot be worn/causes pain, 100=cannot be felt ever) | Baseline and 3 day follow-up |
| Subjective Response for Vision |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meng C Lin, OD, PhD | University of California, Berkeley | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Berkeley Clinical Research Center (UCB-CRC) | Berkeley | California | 94720-2020 | United States |
Three participants were enrolled in the study but did not meet inclusion criteria, therefore discontinued before lens randomization.
Single center evaluation. Thirty five subjects were recruited and 30 subjects completed the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Etafilcon A, Then Filcon II 3 | Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days. etafilcon A: contact lens filcon II 3: contact lens |
| FG001 | Nelfilcon A, Then Filcon II 3 | Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days. nelfilcon A: contact lens filcon II 3: contact lens |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (3 Days) |
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| Second Intervention (3 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Etafilcon A, Then Filcon II 3 | Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days. etafilcon A: contact lens filcon II 3: contact lens |
| BG001 | Nelfilcon A, Then Filcon II 3 |
| 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 |
| 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 Lens Preference - All Study Lenses | Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair of lenses. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2). | Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses. | Posted | Number | participants | Study Exit |
|
From dispense up to 3 days for each study lenses
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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 | Nelfilcon A | Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-lens related | Eye disorders | Systematic Assessment | Only right eye data shown. Left eye data virtually identical. One subject had non-contact lens related adverse event in the nelfilcon A group. Subject temporarily discontinued and went on to complete the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, OD, Sr. Manager Global Medical Scientific Affairs | CooperVision | (925) 621-3761 | jvega@coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| etafilcon A | Device | Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days. |
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| nelfilcon A | Device | Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days. |
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Participant's subjective response for vision measured at baseline and at 3 day follow-up of daily disposable wear of lenses. (Vision Scale 0-100, 0=very blurry, 100=very clear). |
| Baseline and 3 day follow-up |
| Subjective Response for Insertion | Participant's subjective response for insertion measured at baseline. (Insertion Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle). | Baseline |
| Subjective Response for Handling (Insertion and Removal) | Participant's subjective response for handling (insertion and removal) measured at 3 day follow-up of daily disposable wear of lenses. (Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle). | 3 days follow-up |
| Subjective Response for Dryness | Participant's subjective response for dryness, measured at baseline and after 3 day follow-up of daily disposable wear of lenses. (Dryness Scale 0-100, 0=Cannot be worn/extremely dry, 100=no dryness experienced at any time). | 3 Days Follow-up |
| Overall Satisfaction, Vision | Participant's subjective response for overall vision satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied. | 3 Days Follow-up |
| Overall Satisfaction, Comfort | Participant's subjective response for overall comfort satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied. | 3 Days Follow-up |
| Overall Satisfaction, Handling | Participant's subjective response for overall handling satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied. | 3 Days |
| Overall Satisfaction, Dryness | Participant's subjective response for overall dryness satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied. | 3 Days Follow-up |
| Overall Satisfaction | Participant's subjective response for overall satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied. | 3 Days Follow-up |
| Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up) | The investigator's objective assessment for contact lens fit and performance - wettability. Measured at baseline (10-15mins settling) for both study pairs. Wettability (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced). | Baseline and 3 days follow-up |
| Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up) | The investigator's objective assessment for contact lens fit and performance - deposits. Measured at baseline (10-15mins settling) for both study pairs. Deposits (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced); | Baseline and 3 days follow-up |
| Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up) | The investigator's objective assessment for contact lens fit and performance - debris. Measured at baseline (10-15mins settling) for both study pairs. (Debris scale 0-4; 0.25 steps; 0=no debris, 4=significant debris) | Baseline and 3 day follow-up |
| Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up) | The investigator's objective assessment for contact lens fit and performance - movement. Measured at baseline (10-15mins settling) for both study pairs. Movement (scale in millimeters). | Baseline and 3 days follow-up |
| Lens Fit and Performance - Fit Acceptance | The investigator's objective assessment for contact lens fit and performance - fit acceptance. Measured at baseline and 3 day follow-up (10-15mins settling) for both study pairs. Fit acceptance (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect). | Baseline and 3 day follow-up |
| Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up) | The investigator's objective assessment for contact lens fit and performance - tightness. Measured at baseline (10-15mins settling) for both study pairs. Tightness (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect). | Baseline and 3 day follow-up |
| Ocular Health - Biomicroscopy | The investigator's objective assessment of ocular health assessed for each study Pair after 3 days wear by biomicroscopy. Bulbar and Limbal Hyperemia; Corneal Staining Type, Extent and Depth, Conjunctival Staining and Indentation. BrienHolden Vision Institute Continuous Scale: 1-4, 0.5 steps (1=Very, 2=Slight, 3=Moderate, 4=Severe) | 3 Days Follow-up |
| NOT COMPLETED |
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Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days. nelfilcon A: contact lens filcon II 3: contact lens |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A |
| OG002 | Filcon II 3 | Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A |
|
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| Primary | Overall Lens Preference - Hydrogel vs. Filcon II 3 | Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2). | 30 subjects | Posted | Number | participants | Study Exit |
|
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| Secondary | Subjective Response for Comfort | Participant's subjective response for comfort measured at baseline and 3 day follow-up. (Continuous Comfort Scale 0-100, 0=cannot be worn/causes pain, 100=cannot be felt ever) | Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3 day follow-up |
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| Secondary | Subjective Response for Vision | Participant's subjective response for vision measured at baseline and at 3 day follow-up of daily disposable wear of lenses. (Vision Scale 0-100, 0=very blurry, 100=very clear). | Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3 day follow-up |
|
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| Secondary | Subjective Response for Insertion | Participant's subjective response for insertion measured at baseline. (Insertion Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle). | Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
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| Secondary | Subjective Response for Handling (Insertion and Removal) | Participant's subjective response for handling (insertion and removal) measured at 3 day follow-up of daily disposable wear of lenses. (Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle). | Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses. | Posted | Mean | Standard Deviation | units on a scale | 3 days follow-up |
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| Secondary | Subjective Response for Dryness | Participant's subjective response for dryness, measured at baseline and after 3 day follow-up of daily disposable wear of lenses. (Dryness Scale 0-100, 0=Cannot be worn/extremely dry, 100=no dryness experienced at any time). | Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses. | Posted | Mean | Standard Deviation | units on a scale | 3 Days Follow-up |
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| Secondary | Overall Satisfaction, Vision | Participant's subjective response for overall vision satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied. | Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses. | Posted | Number | participants | 3 Days Follow-up |
|
|
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| Secondary | Overall Satisfaction, Comfort | Participant's subjective response for overall comfort satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied. | Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses. | Posted | Number | participants | 3 Days Follow-up |
|
|
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| Secondary | Overall Satisfaction, Handling | Participant's subjective response for overall handling satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied. | Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses. | Posted | Number | participants | 3 Days |
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| Secondary | Overall Satisfaction, Dryness | Participant's subjective response for overall dryness satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied. | Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses. | Posted | Number | participants | 3 Days Follow-up |
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| Secondary | Overall Satisfaction | Participant's subjective response for overall satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied. | Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses. | Posted | Number | participants | 3 Days Follow-up |
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| Secondary | Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up) | The investigator's objective assessment for contact lens fit and performance - wettability. Measured at baseline (10-15mins settling) for both study pairs. Wettability (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3 days follow-up |
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| Secondary | Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up) | The investigator's objective assessment for contact lens fit and performance - deposits. Measured at baseline (10-15mins settling) for both study pairs. Deposits (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced); | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3 days follow-up |
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| Secondary | Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up) | The investigator's objective assessment for contact lens fit and performance - debris. Measured at baseline (10-15mins settling) for both study pairs. (Debris scale 0-4; 0.25 steps; 0=no debris, 4=significant debris) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3 day follow-up |
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| Secondary | Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up) | The investigator's objective assessment for contact lens fit and performance - movement. Measured at baseline (10-15mins settling) for both study pairs. Movement (scale in millimeters). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3 days follow-up |
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| Secondary | Lens Fit and Performance - Fit Acceptance | The investigator's objective assessment for contact lens fit and performance - fit acceptance. Measured at baseline and 3 day follow-up (10-15mins settling) for both study pairs. Fit acceptance (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3 day follow-up |
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| Secondary | Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up) | The investigator's objective assessment for contact lens fit and performance - tightness. Measured at baseline (10-15mins settling) for both study pairs. Tightness (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3 day follow-up |
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| Secondary | Ocular Health - Biomicroscopy | The investigator's objective assessment of ocular health assessed for each study Pair after 3 days wear by biomicroscopy. Bulbar and Limbal Hyperemia; Corneal Staining Type, Extent and Depth, Conjunctival Staining and Indentation. BrienHolden Vision Institute Continuous Scale: 1-4, 0.5 steps (1=Very, 2=Slight, 3=Moderate, 4=Severe) | Only right eye data shown. Left eye data virtually identical. One subject had non-contact lens related adverse event in the nelfilcon A group. Subject temporarily discontinued and went on to complete the study. | Posted | Mean | Standard Deviation | units on a scale | 3 Days Follow-up |
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| 0 |
| 16 |
| 1 |
| 16 |
| EG001 | Etafilcon A | Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A | 0 | 14 | 0 | 14 |
| EG002 | Filcon II 3 | Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A | 0 | 30 | 0 | 30 |
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The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
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| Somewhat Satisfied |
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| Completely Satisfied |
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| Somewhat Satisfied |
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| Completely Satisfied |
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| Somewhat Satisfied |
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| Completely Satisfied |
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| Somewhat Satisfied |
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| Completely Satisfied |
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| Somewhat Satisfied |
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| Completely Satisfied |
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| Bulbar Hyperemia (Superior) |
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| Bulbar Hyperemia (Inferior) |
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| Limbal Hyperemia (Nasal) |
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| Limbal Hyperemia (Temporal) |
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| Limbal Hyperemia (Superior) |
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| Limbal Hyperemia (Inferior) |
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| Corneal Staining Type (Central) |
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| Corneal Staining Type (Nasal) |
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| Corneal Staining Type (Temporal) |
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| Corneal Staining Type (Superior) |
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| Corneal Staining Type (Inferior) |
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| Corneal Staining Extent (Central) |
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| Corneal Staining Extent (Nasal) |
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| Corneal Staining Extent (Temporal) |
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| Corneal Staining Extent (Superior) |
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| Corneal Staining Extent (Inferior) |
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| Corneal Staining Depth (Central) |
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| Corneal Staining Depth (Nasal) |
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| Corneal Staining Depth (Temporal) |
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| Corneal Staining Depth (Superior) |
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| Corneal Staining Depth (Inferior) |
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| Conjunctival Staining (Nasal) |
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| Conjunctival Staining (Temporal) |
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| Conjunctival Staining (Superior) |
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| Conjunctival Staining (Inferior) |
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| Conjunctival Indent (Nasal) |
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| Conjunctival Indent (Temporal) |
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| Conjunctival Indent (Superior) |
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| Conjunctival Indent (Inferior) |
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