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Primary efficacy was not demonstrated in Stage 1
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The purpose of this study is to evaluate the effect of contact lens lubricity on lid wiper epitheliopathy (LWE) in symptomatic contact lens wearers. LWE is defined as an alteration of that portion of the marginal conjunctival epithelium of the upper eyelid that wipes the ocular surface during blinking.
This study will be conducted in two stages. In Stage 1, participants will wear either spectacles or contact lenses for two weeks to determine the impact of interruption of contact lens wear on LWE. In Stage 2, a second cohort of participants will wear one of two contact lens brands for two weeks, and LWE and ocular discomfort will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spectacles, Stage 1 | Experimental | Spectacles per participant's habitual perscription worn for 2 weeks |
|
| 1-DAY ACUVUE, Stage 1 | Active Comparator | Etafilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode |
|
| DAILIES TOTAL1, Stage 2 | Experimental | Delefilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode |
|
| 1-DAY ACUVUE, Stage 2 | Active Comparator | Etafilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectacles | Device | Per participant's habitual prescription |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks | LWE was measured by slit lamp evaluation of fluorescein and lissamine green staining of the upper eyelid. LWE was graded on a scale from 0 to 3, where 0=none and 3=severe. The percent of eyes experiencing at least a 1 grade reduction in LWE (from baseline) at the 2-week visit was compared between groups. One eye (study eye) contributed to the analysis. | Baseline, Week 2 |
| Stage 2: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks | This outcome measure was not evaluated since primary efficacy was not demonstrated. | Baseline, Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Stage 2: Change From Baseline in Ocular Discomfort Score (as Measured by SPEED) at 2 Weeks | This outcome measure was not evaluated since primary efficacy was not demonstrated. | Baseline, Week 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Brobst, OD, FAAO | Alcon Research | Study Director |
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Of the 187 enrolled, 135 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants. Results from Stage 1 were planned to be used to appropriately power Stage 2 of the study. Since primary efficacy cannot be demonstrated in Stage 1, Stage 2 of this study was not conducted.
Participants were recruited from 23 study centers located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spectacles, Stage 1 | Spectacles per participant's habitual perscription worn for 2 weeks |
| FG001 | 1-DAY ACUVUE, Stage 1 | Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This analysis population includes all participants/eyes exposed to investigational products (test and control).
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| ID | Title | Description |
|---|---|---|
| BG000 | Spectacles, Stage 1 | Spectacles per participant's habitual perscription worn for 2 weeks |
| BG001 | 1-DAY ACUVUE, Stage 1 | Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode |
| 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 | Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks | LWE was measured by slit lamp evaluation of fluorescein and lissamine green staining of the upper eyelid. LWE was graded on a scale from 0 to 3, where 0=none and 3=severe. The percent of eyes experiencing at least a 1 grade reduction in LWE (from baseline) at the 2-week visit was compared between groups. One eye (study eye) contributed to the analysis. | This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan. Denominator for percentages is the number of subjects with data available at both time points. | Posted | Number | percentage of subjects | Baseline, Week 2 |
|
Adverse events (AEs) were collected from 15 Jul 2013 to 29 Oct 2013. Reports of AEs were obtained through spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or clinical signs in subjects, users or other persons, whether or not related to the investigational device (test article). This analysis group includes all subjects/eyes exposed to investigational products (test and control).
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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 | Spectacles, Stage 1 | Spectacles per participant's habitual perscription worn for 2 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Brobst, Clinical Project Lead | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Delefilcon A contact lenses |
| Device |
Silicone hydrogel single vision contact lenses |
|
|
| Etafilcon A contact lenses | Device | Hydrogel single vision contact lenses |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 1-DAY ACUVUE, Stage 1 | Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode |
|
|
| Primary | Stage 2: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks | This outcome measure was not evaluated since primary efficacy was not demonstrated. | Posted | Baseline, Week 2 |
|
|
| Secondary | Stage 2: Change From Baseline in Ocular Discomfort Score (as Measured by SPEED) at 2 Weeks | This outcome measure was not evaluated since primary efficacy was not demonstrated. | Posted | Baseline, Week 2 |
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 1-DAY ACUVUE, Stage 1 | Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode | 0 | 27 | 0 | 27 |
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