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The purpose of this study is to compare the change from baseline in central corneal curvature at one week, between 2 silicone hydrogel lenses, in higher myopic subjects.
Participants were expected to attend 4 office visits. Visit 1 was the Screening/Enrollment visit. At Visit 2 (Baseline Visit), participants were randomized and the study lenses were trial fit. At Visit 3 (Dispense Visit), participants received study lenses for approximately 1 week of wear. Visit 4 was the Exit visit. Expected duration of participation in the study was 3 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAILIES TOTAL1 | Experimental | Delefilcon A contact lens randomly assigned to one eye, with narafilcon A contact lens in the fellow eye for contralateral wear. Both products worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week, with spectacles worn over contact lenses if needed to provide acceptable vision. |
|
| TRUEYE | Active Comparator | Narafilcon A contact lens randomly assigned to one eye, with delefilcon A contact lens in the fellow eye for contralateral wear. Both products worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week, with spectacles worn over contact lenses if needed to provide acceptable vision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A contact lens | Device | Commercially available silicone hydrogel contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Central Corneal Curvature From Dispense at Week 1 | Corneal curvature (horizontal and vertical keratometry values on the same eye) was measured using a calibrated keratometer prior to study lens dispense (Day 1) and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Minus values in change-from-baseline indicate corneal flattening. | Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1 | Subjective manifest refraction was assessed using a phoropter or trial frame set with the subject's current prescription at Baseline (Visit 2) after a 2-day washout period and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Spectacle over-refraction, if required, was performed. Higher myopia is indicated by larger negative values in manifest refraction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joachim Nick, Dipl. Ing. | Alcon Research | Study Director |
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Of the 19 enrolled, 4 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (15).
Participants were recruited from 2 study centers located in the US and 2 study centers located in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | DAILIES TOTAL1/TRUEYE | Delefilcon A and narafilcon A contact lenses (1 in each eye) worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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This analysis group includes all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | DAILIES TOTAL1/TRUEYE | Delefilcon A and narafilcon A contact lenses (1 in each eye) worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week. |
| 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 | Change in Average Central Corneal Curvature From Dispense at Week 1 | Corneal curvature (horizontal and vertical keratometry values on the same eye) was measured using a calibrated keratometer prior to study lens dispense (Day 1) and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Minus values in change-from-baseline indicate corneal flattening. | This analysis group includes all randomized participants with data present at visit. | Posted | Mean | Standard Deviation | diopters | Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear) |
|
Adverse events (AEs) were collected for the duration of the study (March, 2014 - May, 2014). This analysis group includes all participants/eyes exposed to the study products. Trial-fit lenses were not considered study products.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational medical device.
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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 | DAILIES TOTAL1 | Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foreign body sensation in eyes | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Lead, Vision Care Development | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| ID | Term |
|---|---|
| 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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| Narafilcon A contact lens | Device | Commercially available silicone hydrogel contact lens |
|
|
| Spectacles | Device | Incremental prescription worn over contact lenses if needed to provide acceptable vision |
|
| Baseline, Week 1 (Day 8 of lens wear) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week. |
|
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| Secondary | Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1 | Subjective manifest refraction was assessed using a phoropter or trial frame set with the subject's current prescription at Baseline (Visit 2) after a 2-day washout period and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Spectacle over-refraction, if required, was performed. Higher myopia is indicated by larger negative values in manifest refraction. | This analysis group includes all randomized participants with data present at visit. | Posted | Number | Eyes | Baseline, Week 1 (Day 8 of lens wear) |
|
|
|
| 0 |
| 15 |
| 4 |
| 15 |
| EG001 | TRUEYE | Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week | 0 | 15 | 1 | 15 |
| Metamorphopsia | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Myokymia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
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| Ocular discomfort | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Punctate keratitis | Eye disorders | MedDRA (16.0) | Systematic Assessment |
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| Topography corneal abnormal | Investigations | MedDRA (16.0) | Systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.