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| ID | Type | Description | Link |
|---|---|---|---|
| P/319/08/C | Other Identifier | University of Waterloo |
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The purpose of this study was to compare a new daily disposable, silicone hydrogel contact lens to marketed daily disposable, silicone hydrogel contact lenses.
Part 1 of the study involved bilateral wear of three different types of marketed contact lenses. Each type of lens was worn for three consecutive days of daily disposable wear. Participants had been previously identified as symptomatic lens wearers or asymptomatic lens wearers, based upon their responses to a screening questionnaire. Participants wore each lens type for as long as they were comfortable during the day, but lenses were removed before sleep. After completion of Part 1, participants began Part 2, which included dispensing of the investigational study lens for up to one week of bilateral wear, with a single follow-up visit at the end of that period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| delefilcon A | Experimental | Part 1: Delefilcon A contact lenses, followed by filcon II 3 contact lenses and narafilcon A contact lenses (in randomized order). Each product worn for three consecutive days, with a minimum 1-day washout between each product. At the conclusion of this wear cycle, the delefilcon A contact lenses were worn in Part 2 for one additional week. All products worn bilaterally in a daily wear, daily disposable modality. |
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| filcon II 3 | Active Comparator | Part 1: Filcon II 3 contact lenses, followed by narafilcon A contact lenses and delefilcon A contact lenses (in randomized order). Each product worn for three consecutive days, with a minimum 1-day washout between each product. At the conclusion of this wear cycle, the delefilcon A contact lenses were worn in Part 2 for one additional week. All products worn bilaterally in a daily wear, daily disposable modality. |
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| narafilcon A | Active Comparator | Part 1: Narafilcon A contact lenses, followed by filcon II 3 contact lenses and delefilcon A contact lenses (in randomized order). Each product worn for three consecutive days, with a minimum 1-day washout between each product. At the conclusion of this wear cycle, the delefilcon A contact lenses were worn in Part 2 for one additional week. All products worn bilaterally in a daily wear, daily disposable modality. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| delefilcon A contact lens | Device | Investigational, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1 and one week in Part 2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Value of Comfort During the Day | The participant recorded a number from 0 to 100 in response to the question, "How would you rate the comfort of your lenses over the last hour?" in which 0 = very poor and 100 = excellent. Comfort was assessed at 4 hours, 8 hours, and 12 hours, and the responses were averaged. | Part 1: Day 2 at 4 hours, 8 hours, and 12 hours |
| Mean Overall Comfort Given at End of Wear | The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall comfort of these lenses?" in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day. | Part 1: Day 3 |
| Mean Overall Quality of Vision at End of Wear | The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall quality of vision while wearing these lenses?" in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day. | Part 1: Day 3 |
| Mean Overall Ease of Handling at End of Wear | The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall ease of handling these lenses?" in which 0 = very difficult and 100 = very easy. The end of wear questionnaire was completed at time of lens removal for that day. | Part 1: Day 3 |
| Percentage of Participants Reporting That Their Eyes Rarely or Never Felt Dry at End of Wear | The participant circled a number from 0 to 4 in response to the question, "Over the entire day while wearing these contact lenses, how often did your eyes feel dry?" in which 0 = never, 1 = rarely, 2 = sometimes, 3 = frequently, 4 = constantly. The end of wear questionnaire was completed at time of lens removal for that day. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones, PhD FAAO | Centre for Contact Lens Research, School of Optometry, University of Waterloo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Waterloo Centre for Contact Lens Research | Waterloo | Ontario | N2L 3G1 | Canada |
10 people were enrolled but not dispensed into Part 1 due to failing inclusion/exclusion criteria.
Participants were recruited from 1 study center in Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delefilcon A / Filcon II 3 / Narafilcon A | Part 1: Delefilcon A, then Filcon II 3, then Narafilcon A, 3 days each. Part 2: Delefilcon A for 1 week. |
| FG001 | Narafilcon A / Filcon II 3 / Delefilcon A | Part 1: Narafilcon A, then Filcon II 3, then Delefilcon A, 3 days each. Part 2: Delefilcon A for 1 week. |
| FG002 | Filcon II 3 / Narafilcon A / Delefilcon A | Part 1: Filcon II 3, then Narafilcon A, the Delefilcon A, 3 days each. Part 2: Delefilcon A for 1 week. |
| FG003 | Delefilcon A / Narafilcon A / Filcon II 3 | Part 1: Delefilcon A, then Narafilcon A, then Filcon II 3, 3 days each. Part 2: Delefilcon A for 1 week. |
| FG004 | Narafilcon A / Delefilcon A / Filcon II 3 | Part 1: Narafilcon A, then Delefilcon A, then Filcon II 3, 3 days each. Part 2: Delefilcon A for 1 week. |
| FG005 | Filcon II 3 / Delefilcon A / Narafilcon A | Part 1: Filcon II 3, then Delefilcon A, then Narafilcon A, 3 days each. Part 2: Delefilcon A for 1 week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1, First 3 Days |
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| Part 1, Second 3 Days |
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| Part 1, Third 3 Days |
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| Part 2, One Week |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | This reporting group includes all enrolled participants. |
| 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 | Mean Value of Comfort During the Day | The participant recorded a number from 0 to 100 in response to the question, "How would you rate the comfort of your lenses over the last hour?" in which 0 = very poor and 100 = excellent. Comfort was assessed at 4 hours, 8 hours, and 12 hours, and the responses were averaged. | This reporting group includes all participants who completed 12 hours of lens wear on Day 2. | Posted | Mean | Standard Deviation | Units on a scale | Part 1: Day 2 at 4 hours, 8 hours, and 12 hours |
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Adverse events were collected for the duration of the study.
The safety reporting group includes all enrolled and exposed participants.
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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 | Delefilcon A | Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redness | Eye disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joachim Nick, Dipl. Ing. | Alcon Research, Ltd. | +49 6022 240 520 | joachim.nick@cibavision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| filcon II 3 contact lenses | Device | Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1. |
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| narafilcon A contact lenses | Device | Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1. |
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| Part 1: Day 2 |
| Percentage of Participants Preferring Study Lens Either Strongly or Slightly (of Those With a Preference) vs. Their Habitual Lenses at End of Wear | The participant circled a number from 1 to 5 in response to the question, "Overall, which lens do you prefer - the lens you wore today or your regular lenses?" in which 1 = strongly prefer my regular lenses, 2 = prefer my regular lenses, 3 = no preference, 4 = prefer test lens, 5 = strongly prefer test lens. The end of wear questionnaire was completed at time of lens removal for that day. | Part 1: Day 3 |
| Lens Wettability | Lens wettability was assessed by the investigator during slit-lamp examination and graded on a 0-4 scale in 0.25 steps, where 0 = excellent and 4 = severely reduced. | Part 1: Day 1 at Dispense, Day 1 at 8 hours, Day 3 at 8 hours |
| Percentage of Participants Responding "Yes" | The participant responded to 11 subjective, performance-related statements on a questionnaire by circling 1 = yes, 2 = no, or 3 = don't know. | Part 2: Day 7 |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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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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| Region of Enrollment | Number | participants |
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Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
| OG002 | Narafilcon A | Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1 |
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| Primary | Mean Overall Comfort Given at End of Wear | The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall comfort of these lenses?" in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day. | This reporting group includes all participants who completed all three lens wear periods in Part 1. | Posted | Mean | Standard Deviation | Units on a scale | Part 1: Day 3 |
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| Primary | Mean Overall Quality of Vision at End of Wear | The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall quality of vision while wearing these lenses?" in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day. | This reporting group includes all participants who completed all three lens wear periods in Part 1. | Posted | Mean | Standard Deviation | Units on a scale | Part 1: Day 3 |
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| Primary | Mean Overall Ease of Handling at End of Wear | The participant recorded a number from 0 to 100 in response to the question, "How would you rate the overall ease of handling these lenses?" in which 0 = very difficult and 100 = very easy. The end of wear questionnaire was completed at time of lens removal for that day. | This reporting group includes all participants who completed all three lens wear periods in Part 1. | Posted | Mean | Standard Deviation | Units on a scale | Part 1: Day 3 |
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| Primary | Percentage of Participants Reporting That Their Eyes Rarely or Never Felt Dry at End of Wear | The participant circled a number from 0 to 4 in response to the question, "Over the entire day while wearing these contact lenses, how often did your eyes feel dry?" in which 0 = never, 1 = rarely, 2 = sometimes, 3 = frequently, 4 = constantly. The end of wear questionnaire was completed at time of lens removal for that day. | This reporting group includes all participants who completed all three lens wear periods in Part 1. | Posted | Number | Percentage of participants | Part 1: Day 2 |
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| Primary | Percentage of Participants Preferring Study Lens Either Strongly or Slightly (of Those With a Preference) vs. Their Habitual Lenses at End of Wear | The participant circled a number from 1 to 5 in response to the question, "Overall, which lens do you prefer - the lens you wore today or your regular lenses?" in which 1 = strongly prefer my regular lenses, 2 = prefer my regular lenses, 3 = no preference, 4 = prefer test lens, 5 = strongly prefer test lens. The end of wear questionnaire was completed at time of lens removal for that day. | This reporting group includes all participants who completed all three lens wear periods in Part 1. | Posted | Number | Percentage of participants | Part 1: Day 3 |
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| Primary | Lens Wettability | Lens wettability was assessed by the investigator during slit-lamp examination and graded on a 0-4 scale in 0.25 steps, where 0 = excellent and 4 = severely reduced. | This reporting group includes all participants who completed all three lens wear periods in Part 1. | Posted | Mean | Standard Deviation | Units on a scale | Part 1: Day 1 at Dispense, Day 1 at 8 hours, Day 3 at 8 hours |
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| Primary | Percentage of Participants Responding "Yes" | The participant responded to 11 subjective, performance-related statements on a questionnaire by circling 1 = yes, 2 = no, or 3 = don't know. | This reporting group includes all participants who completed Part 2. | Posted | Number | Percentage of participants | Part 2: Day 7 |
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| 0 |
| 117 |
| 0 |
| 117 |
| EG001 | Filcon II 3 | Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1 | 0 | 117 | 12 | 117 |
| EG002 | Narafilcon A | Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1 | 0 | 117 | 1 | 117 |
For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.
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| Day 3 at 8 hours |
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| Title | Measurements |
|---|---|
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| These lenses are very easy to insert on my eye |
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| Lenses provide excellent comfort during the day |
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| Lenses provide excellent comfort at the end of day |
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| So comfortable I almost forget I am wearing lenses |
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| Deliver comfort/vision long days/demanding schedul |
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| Total package-great vision, comfort, convenience |
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| My life is demanding. Lenses meet those demands |
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| I need high performance-these lenses deliver |
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