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The purpose of this trial is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of 5 different daily disposable contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nelfilcon A | Experimental | Nelfilcon A contact lens |
|
| Narafilcon A | Active Comparator | Narafilcon A contact lens |
|
| Etafilcon A | Active Comparator | Etafilcon A contact lens |
|
| Omafilcon A | Active Comparator | Omafilcon A contact lens |
|
| Hilafilcon B | Active Comparator | Hilafilcon B contact lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelfilcon A contact lens | Device | Daily disposable contact lens worn in a daily wear, daily disposable mode |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Awareness | Lens awareness, as interpreted by the subject, was reported by the subject as a single, retrospective evaluation of 4 week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement. | 4 weeks of wear |
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Inclusion Criteria:
Exclusion Criteria:
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Two participants were enrolled but not dispensed due to failing inclusion/exclusion criteria. These participants were included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nelfilcon A | Nelfilcon A contact lens |
| FG001 | Narafilcon A | Narafilcon A contact lens |
| FG002 | Etafilcon A | Etafilcon A contact lens |
| FG003 | Omafilcon A | Omafilcon A contact lens |
| FG004 | Hilafilcon B | Hilafilcon B contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nelfilcon A | Nelfilcon A spherical contact lens worn on a daily wear, daily disposable basis |
| BG001 | Narafilcon A | Narafilcon A spherical contact lens worn on a daily wear, daily disposable basis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | This reporting group includes all enrolled and dispensed subjects. |
| 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 | Lens Awareness | Lens awareness, as interpreted by the subject, was reported by the subject as a single, retrospective evaluation of 4 week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement. | Per protocol. Analysis excluded major protocol deviations as determined by masked review. | Posted | Number | Participants | 4 weeks of wear |
|
8-1/2 weeks, duration of the study
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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 | Nelfilcon A | Nelfilcon A contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs | CIBA VISION | 1-800-241-7629 | priya.janakiraman@cibavision.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Narafilcon A contact lens | Device | Daily disposable contact lens worn in a daily wear, daily disposable mode |
|
| Etafilcon A contact lens | Device | Daily disposable contact lens worn in a daily wear, daily disposable mode |
|
| Omafilcon A contact lens | Device | Daily disposable contact lens worn in a daily wear, daily disposable mode |
|
| Hilafilcon B contact lens | Device | Daily disposable contact lens worn in a daily wear, daily disposable mode |
|
| Lost to Follow-up |
|
| BG002 | Etafilcon A | Etafilcon A spherical contact lens worn on a daily wear, daily disposable basis |
| BG003 | Omafilcon A | Omafilcon A spherical contact lens worn on a daily wear, daily disposable basis |
| BG004 | Hilafilcon B | Hilafilcon B spherical contact lens worn on a daily wear, daily disposable basis |
| BG005 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | This reporting group includes all enrolled and dispensed subjects. | Count of Participants | Participants |
|
| OG002 | Etafilcon A | Etafilcon A contact lens |
| OG003 | Omafilcon A | Omafilcon A contact lens |
| OG004 | Hilafilcon B | Hilafilcon B contact lens |
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Narafilcon A | Narafilcon A contact lens | 0 | 25 | 0 | 25 |
| EG002 | Etafilcon A | Etafilcon A contact lens | 0 | 26 | 0 | 26 |
| EG003 | Omafilcon A | Omafilcon A contact lens | 0 | 25 | 0 | 25 |
| EG004 | Hilafilcon B | Hilafilcon B contact lens | 0 | 24 | 0 | 24 |
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.