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The purpose of this study was to compare three CE-marked daily disposable contact lenses for tear film stability as measured by pre-lens non-invasive keratograph break up time (PL NIK-BUT). Secondarily, contact lens surface wettability was assessed.
Each participant wore 3 brands of contact lenses in a randomized, cross-over fashion, with a washout phase of at least 1 night between brands.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAILIES AquaComfort Plus | Experimental | Nelfilcon A contact lenses worn first, followed by etafilcon A and omafilcon A in randomized order. Each product worn for 1 day, 12 hours. |
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| 1-DAY ACUVUE MOIST | Active Comparator | Etafilcon A contact lenses worn first, followed by nelfilcon A and omafilcon A in randomized order. Each product worn for 1 day, 12 hours. |
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| Proclear 1 day | Active Comparator | Omafilcon A contact lenses worn first, followed by etafilcon A and nelfilcon A in randomized order. Each product worn for 1 day, 12 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelfilcon A contact lenses | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours | The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean. | Hour 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Wettability Score | The investigator graded lens wettability by corneal region using a scale from 0 (fully wettable) to 3 (clearly visible ring distortions in more than 1/3 of ring reflection zone). The total wettability score per eye was calculated by averaging the grade of each of the 5 corneal regions (central, superior, nasal, inferior, and temporal). One eye (right eye) contributed to the mean. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessie Lemp, PhD | Alcon Research | Study Director |
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Of the 30 enrolled, 2 participants discontinued before product was dispensed. This reporting group includes all participants exposed to the study product (28). In this 3-treatment, 6-sequence crossover study, each participant received all 3 products in randomized order and used 1 product at a time for a duration of 12 hours.
Participants were recruited from 1 study center located in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Omafilcon A contact lenses worn first, followed by nelfilcon A contact lenses worn second, then etafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours. |
| FG001 | Sequence 2 | Omafilcon A contact lenses worn first, followed by etafilcon A contact lenses worn second, then nelfilcon A contact lenses worn last. Each product worn for 1 day, 12 hours. |
| FG002 | Sequence 3 | Nelfilcon A contact lenses worn first, followed by etafilcon A contact lenses worn second, then omafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours. |
| FG003 | Sequence 4 | Nelfilcon A contact lenses worn first, followed by omafilcon A contact lenses worn second, then etafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours. |
| FG004 | Sequence 5 | Etafilcon A contact lenses worn first, followed by omafilcon A contact lenses worn second, then nelfilcon A contact lenses worn last. Each product worn for 1 day, 12 hours. |
| FG005 | Sequence 6 | Etafilcon A contact lenses worn first, followed by nelfilcon A contact lenses worn second, then omafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, First Day of Wear |
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| Period 2, Second Day of Wear |
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| Period 3, Third Day of Wear |
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This analysis population includes all participants who were exposed to a study product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Nelfilcon A contact lenses, etafilcon A contact lenses, and omafilcon A contact lenses worn in a cross-over assignment. |
| 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 | Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours | The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean. | This analysis population includes all participants exposed to the study product with reportable values. | Posted | Mean | Standard Deviation | seconds | Hour 8 |
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Adverse events (AEs) were collected for the duration of the study (2 months). This analysis group includes all enrolled participants.
An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the 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 AquaComfort Plus | Nelfilcon A contact lenses worn in a randomized order for 1 day, 12 hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessie Lemp, GMA Brand Lead | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Omafilcon A contact lenses |
| Device |
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| Etafilcon A contact lenses | Device |
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| Hour 8 |
| 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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| OG001 | 1-DAY ACUVUE MOIST | Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours |
| OG002 | Proclear 1 Day | Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours |
|
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| Secondary | Total Wettability Score | The investigator graded lens wettability by corneal region using a scale from 0 (fully wettable) to 3 (clearly visible ring distortions in more than 1/3 of ring reflection zone). The total wettability score per eye was calculated by averaging the grade of each of the 5 corneal regions (central, superior, nasal, inferior, and temporal). One eye (right eye) contributed to the mean. | This analysis population includes all participants exposed to the study product with reportable values. | Posted | Mean | Standard Deviation | units on a scale | Hour 8 |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 1-DAY ACUVUE MOIST | Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours | 0 | 30 | 0 | 30 |
| EG002 | Proclear 1 Day | Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours | 0 | 30 | 0 | 30 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
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| 15 seconds post blink |
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| 20 seconds post blink |
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| 25 seconds post blink |
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