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This is a study to evaluate the performance of fanfilcon A lens when worn on a daily wear modality over approximately 1 month in comparison to the lotrafilcon B lens.
This is a 45 subject, 1-month dispensing, crossover, double-masked, randomized, bilateral study comparing the test lens against the control lens. Both test and control lenses will be used in a daily wear modality for 1 month each.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fanfilcon A | Active Comparator | Study participants are randomized to wear fanfilcon A lens during the crossover study |
|
| lotrafilcon B | Active Comparator | Study participants are randomized to wear lotrafilcon B lens during the crossover study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fanfilcon A | Device | contact lens |
| |
| lotrafilcon B |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Comfort | Subjective ratings on comfort at insertion (at baseline), comfort when lenses are first put in, comfort during the day's wear, and comfort prior to lens removal (1 month) for fanfilcon A and lotrafilcon B lens. (Scale 0-10, 10=Can't feel the lenses, 0=Painful). | Baseline, 1 month |
| Subjective Preference | Subjective ratings on preference for fanfilcon A and lotrafilcon B lens. (Strongly prefer fanfilcon A, slightly prefer fanfilcon A, no preference, slightly prefer lotrafilcon B, strongly prefer lotrafilcon B). Subject preference in terms of comfort, dryness, clear vision, Lens Handling, digital devices, all day natural comfort, All day comfort, same comfort at the end of the day (EOD), comfortable after the end of 4 weeks, Same comfort at 4 weeks as initial, comfortable in dry environments, help focus effortlessly while using digital devices, help with end of day (EOD) dryness, help eyes feel less tired at EOD (including computer or digital device use), offering clear vision during driving. | 1 month |
| Lens Wettability | Lens wettability for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced) | Baseline, 1 month |
| Surface Deposits | Surface deposits for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced) | Baseline, 1 month |
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Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
Exclusion Criteria:
A person will be excluded from the study if he/she:
Is participating in any concurrent clinical or research study;
Is a habitual wearer of lotrafilcon B or enfilcon A lenses.
Has any known active* ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
Is pregnant, lactating or planning a pregnancy at the time of enrollment; (by verbal confirmation at the Screening Visit)
Is aphakic;
Has undergone refractive error surgery;
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones | Director, Centre for Contact Lens Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Contact Lens Research, University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fanfilcon A Then Lotrafilcon B | Study participants are randomized to wear fanfilcon A lens for 1 month, then lotrafilcon B for 1 month during the crossover study fanfilcon A: contact lens lotrafilcon B: contact lens |
| FG001 | Lotrafilcon B Then Fanfilcon A | Study participants are randomized to wear lotrafilcon B for 1 month, then fanfilcon A lens for 1 month during the crossover study. lotrafilcon B: contact lens fanfilcon A: contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Month) |
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| Second Intervention (1 Month) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | Study participants are randomized to wear fanfilcon A lens or lotrafilcon B lens for 1 month during the crossover study fanfilcon A: contact lens lotrafilcon B: contact lens |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Subjective Comfort | Subjective ratings on comfort at insertion (at baseline), comfort when lenses are first put in, comfort during the day's wear, and comfort prior to lens removal (1 month) for fanfilcon A and lotrafilcon B lens. (Scale 0-10, 10=Can't feel the lenses, 0=Painful). | Posted | Median | Standard Deviation | units on a scale | Baseline, 1 month |
|
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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 | Fanfilcon A | Study participants are randomized to wear fanfilcon A lens during the crossover study fanfilcon A: contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Global Medical Scientific Affairs | CooperVision | 925-621-3761 | javega@coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Device |
contact lens |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Primary | Subjective Preference | Subjective ratings on preference for fanfilcon A and lotrafilcon B lens. (Strongly prefer fanfilcon A, slightly prefer fanfilcon A, no preference, slightly prefer lotrafilcon B, strongly prefer lotrafilcon B). Subject preference in terms of comfort, dryness, clear vision, Lens Handling, digital devices, all day natural comfort, All day comfort, same comfort at the end of the day (EOD), comfortable after the end of 4 weeks, Same comfort at 4 weeks as initial, comfortable in dry environments, help focus effortlessly while using digital devices, help with end of day (EOD) dryness, help eyes feel less tired at EOD (including computer or digital device use), offering clear vision during driving. | Posted | Number | percentage of participants | 1 month |
|
|
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| Primary | Lens Wettability | Lens wettability for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced) | One participant excluded from analysis at 1 month. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 month |
|
|
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| Primary | Surface Deposits | Surface deposits for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced) | One participant excluded from analysis at 1 month. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 month |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Lotrafilcon B | Study participants are randomized to wear lotrafilcon B lens during the crossover study. lotrafilcon B: contact lens | 0 | 49 | 0 | 49 |
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| Dryness |
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| Clear vision |
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| Lens Handling |
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| Digital devices |
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| All day natural comfort |
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| All day comfort |
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| Same comfort at EOD |
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| Comfortable after the end of 4 weeks |
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| Same comfort at 4 weeks as initial |
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| Comfortable in dry environments |
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| Help focus effortlessly while using digital device |
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| Help with EOD dryness |
|
| Help eyes feel less tired at EOD |
|
| Offering clear vision during driving. |
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| 1 month |
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| 1 Month |
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