Myopia
Conditions
Brief summary
The purpose of this study was to compare a new daily disposable, silicone hydrogel contact lens to marketed daily disposable, silicone hydrogel contact lenses.
Detailed description
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.
Interventions
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.
DEVICEfilcon II 3 contact lenses
Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.
Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.
Sponsors
CIBA VISION
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 17 years of age; full legal capacity to volunteer. * Ocular examination within the last two years * Correctable to a visual acuity of 20/30 or better (in each eye) with habitual vision correction. * Currently wearing soft contact lenses. * Clear corneas; no active ocular disease. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Currently wearing 1-DAY ACUVUE TruEye or Sauflon Clariti 1-DAY contact lenses. * Monovision. * Any ocular disease. * Never worn contact lenses before. * Corneal refractive surgery. * Uses topical ocular medicine. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Value of Comfort During the Day | Part 1: Day 2 at 4 hours, 8 hours, and 12 hours | 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. |
| Mean Overall Comfort Given at End of Wear | Part 1: Day 3 | 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. |
| Mean Overall Quality of Vision at End of Wear | Part 1: Day 3 | 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. |
| Mean Overall Ease of Handling at End of Wear | Part 1: Day 3 | 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. |
| Percentage of Participants Reporting That Their Eyes Rarely or Never Felt Dry at End of Wear | Part 1: Day 2 | 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. |
| Percentage of Participants Preferring Study Lens Either Strongly or Slightly (of Those With a Preference) vs. Their Habitual Lenses at End of Wear | Part 1: Day 3 | 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. |
| Lens Wettability | Part 1: Day 1 at Dispense, Day 1 at 8 hours, Day 3 at 8 hours | 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. |
| Percentage of Participants Responding Yes | Part 2: Day 7 | The participant responded to 11 subjective, performance-related statements on a questionnaire by circling 1 = yes, 2 = no, or 3 = don't know. |
Countries
Canada
Participant flow
Recruitment details
Participants were recruited from 1 study center in Canada.
Pre-assignment details
10 people were enrolled but not dispensed into Part 1 due to failing inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study This reporting group includes all enrolled participants. | 119 |
| Total | 119 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Part 1, First 3 Days | Inconvenience | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age Continuous | 27 years STANDARD_DEVIATION 9 |
| Region of Enrollment Canada | 119 participants |
| Sex: Female, Male Female | 89 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 117 | 12 / 117 | 1 / 117 |
| serious Total, serious adverse events | 0 / 117 | 0 / 117 | 0 / 117 |
Outcome results
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.
Time frame: Part 1: Day 1 at Dispense, Day 1 at 8 hours, Day 3 at 8 hours
Population: This reporting group includes all participants who completed all three lens wear periods in Part 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Delefilcon A | Lens Wettability | Day 3 at 8 hours | 0.51 Units on a scale | Standard Deviation 0.47 |
| Delefilcon A | Lens Wettability | Day 1 at 8 hours | 0.46 Units on a scale | Standard Deviation 0.5 |
| Delefilcon A | Lens Wettability | Day 1 at Dispense | 0.25 Units on a scale | Standard Deviation 0.39 |
| Filcon II 3 | Lens Wettability | Day 1 at 8 hours | 0.77 Units on a scale | Standard Deviation 0.55 |
| Filcon II 3 | Lens Wettability | Day 1 at Dispense | 0.49 Units on a scale | Standard Deviation 0.5 |
| Filcon II 3 | Lens Wettability | Day 3 at 8 hours | 0.76 Units on a scale | Standard Deviation 0.66 |
| Narafilcon A | Lens Wettability | Day 1 at Dispense | 0.46 Units on a scale | Standard Deviation 0.46 |
| Narafilcon A | Lens Wettability | Day 3 at 8 hours | 0.91 Units on a scale | Standard Deviation 0.72 |
| Narafilcon A | Lens Wettability | Day 1 at 8 hours | 0.89 Units on a scale | Standard Deviation 0.69 |
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.
Time frame: Part 1: Day 3
Population: This reporting group includes all participants who completed all three lens wear periods in Part 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | Mean Overall Comfort Given at End of Wear | 90 Units on a scale | Standard Deviation 10 |
| Filcon II 3 | Mean Overall Comfort Given at End of Wear | 83 Units on a scale | Standard Deviation 16 |
| Narafilcon A | Mean Overall Comfort Given at End of Wear | 86 Units on a scale | Standard Deviation 15 |
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.
Time frame: Part 1: Day 3
Population: This reporting group includes all participants who completed all three lens wear periods in Part 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | Mean Overall Ease of Handling at End of Wear | 90 Units on a scale | Standard Deviation 13 |
| Filcon II 3 | Mean Overall Ease of Handling at End of Wear | 91 Units on a scale | Standard Deviation 12 |
| Narafilcon A | Mean Overall Ease of Handling at End of Wear | 93 Units on a scale | Standard Deviation 10 |
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.
Time frame: Part 1: Day 3
Population: This reporting group includes all participants who completed all three lens wear periods in Part 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | Mean Overall Quality of Vision at End of Wear | 91 Units on a scale | Standard Deviation 10 |
| Filcon II 3 | Mean Overall Quality of Vision at End of Wear | 87 Units on a scale | Standard Deviation 12 |
| Narafilcon A | Mean Overall Quality of Vision at End of Wear | 88 Units on a scale | Standard Deviation 13 |
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.
Time frame: Part 1: Day 2 at 4 hours, 8 hours, and 12 hours
Population: This reporting group includes all participants who completed 12 hours of lens wear on Day 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delefilcon A | Mean Value of Comfort During the Day | 89 Units on a scale | Standard Deviation 11 |
| Filcon II 3 | Mean Value of Comfort During the Day | 85 Units on a scale | Standard Deviation 13 |
| Narafilcon A | Mean Value of Comfort During the Day | 86 Units on a scale | Standard Deviation 13 |
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.
Time frame: Part 1: Day 3
Population: This reporting group includes all participants who completed all three lens wear periods in Part 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delefilcon A | Percentage of Participants Preferring Study Lens Either Strongly or Slightly (of Those With a Preference) vs. Their Habitual Lenses at End of Wear | 62 Percentage of participants |
| Filcon II 3 | Percentage of Participants Preferring Study Lens Either Strongly or Slightly (of Those With a Preference) vs. Their Habitual Lenses at End of Wear | 35 Percentage of participants |
| Narafilcon A | Percentage of Participants Preferring Study Lens Either Strongly or Slightly (of Those With a Preference) vs. Their Habitual Lenses at End of Wear | 54 Percentage of participants |
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.
Time frame: Part 1: Day 2
Population: This reporting group includes all participants who completed all three lens wear periods in Part 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delefilcon A | Percentage of Participants Reporting That Their Eyes Rarely or Never Felt Dry at End of Wear | 63 Percentage of participants |
| Filcon II 3 | Percentage of Participants Reporting That Their Eyes Rarely or Never Felt Dry at End of Wear | 38 Percentage of participants |
| Narafilcon A | Percentage of Participants Reporting That Their Eyes Rarely or Never Felt Dry at End of Wear | 57 Percentage of participants |
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.
Time frame: Part 2: Day 7
Population: This reporting group includes all participants who completed Part 2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Delefilcon A | Percentage of Participants Responding Yes | These lenses provide excellent comfort | 85 Percentage of participants |
| Delefilcon A | Percentage of Participants Responding Yes | These lenses provide excellent quality of vision | 87 Percentage of participants |
| Delefilcon A | Percentage of Participants Responding Yes | These lenses are very easy to handle | 83 Percentage of participants |
| Delefilcon A | Percentage of Participants Responding Yes | These lenses are very easy to insert on my eye | 88 Percentage of participants |
| Delefilcon A | Percentage of Participants Responding Yes | Lenses provide excellent comfort during the day | 89 Percentage of participants |
| Delefilcon A | Percentage of Participants Responding Yes | Lenses provide excellent comfort at the end of day | 64 Percentage of participants |
| Delefilcon A | Percentage of Participants Responding Yes | So comfortable I almost forget I am wearing lenses | 67 Percentage of participants |
| Delefilcon A | Percentage of Participants Responding Yes | Deliver comfort/vision long days/demanding schedul | 72 Percentage of participants |
| Delefilcon A | Percentage of Participants Responding Yes | Total package-great vision, comfort, convenience | 73 Percentage of participants |
| Delefilcon A | Percentage of Participants Responding Yes | My life is demanding. Lenses meet those demands | 64 Percentage of participants |
| Delefilcon A | Percentage of Participants Responding Yes | I need high performance-these lenses deliver | 70 Percentage of participants |