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The objective of this study is to compare the ease of removing two daily disposable soft contact lenses off the eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| delefilcon A | Active Comparator | Spherical daily disposable soft contact lens |
|
| narafilcon A | Experimental | Spherical daily disposable soft contact lens Class 1 UV blocking |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| delefilcon A | Device | Daily disposable soft contact lens to be worn at least 8 hours daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Ease of Lens Removal | After 1-week of lens wear, each subject was asked to rate a question, 'Ease of taking the lenses off of your eyes', using 5-point scale (1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor). | Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Knowle | Bristol | BS4 2AL | United Kingdom | |||
A total of 279 subjects were enrolled in the study; 4 did not meet the eligibility criteria, 2 prematurely discontinued and 273 completed the study. Of those 273 completers, 23 were excluded from the primary analysis due to major protocol deviations; hence, 250 completed the study per protocol and were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delefilcon A | Spherical daily disposable soft contact lens |
| FG001 | Narafilcon A | Spherical daily disposable soft contact lens with UV blocking |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Delefilcon A | Spherical daily disposable soft contact lens delefilcon A: Daily disposable soft contact lens to be worn at least 8 hours daily |
| BG001 | Narafilcon A | Spherical daily disposable soft contact lens Class 1 UV blocking narafilcon A: Daily disposable contact lens to be worn at least 8 hours daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Data was collected on those subjects 18 years and older, there were no pediatric patients enrolled in the study. |
| 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 | Subjective Ease of Lens Removal | After 1-week of lens wear, each subject was asked to rate a question, 'Ease of taking the lenses off of your eyes', using 5-point scale (1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor). | Posted | Number | participants | Day 7 |
|
|
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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 | Delefilcon A | Spherical daily disposable soft contact lens delefilcon A: Daily disposable soft contact lens to be worn at least 8 hours daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daria Wicks | Johnson & Johnson Vision Care | 1 904 443-1391 | RA-VISUS-ClnclStds@its.jnj.com |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| narafilcon A | Device | Daily disposable contact lens to be worn at least 8 hours daily |
|
|
| Portchester |
| Hampshire |
| PO16 9UN |
| United Kingdom |
| Hay-on-wye | Herefordshire | HR3 5EQ | United Kingdom |
| St Albans | Herts | AL1 3LH | United Kingdom |
| Eastcote, Pinner | Middlesex | HA5 1RJ | United Kingdom |
| Cardiff | South Glamorgan | CF24 3RQ | United Kingdom |
| Farnham | Surrey | GU9 7EN | United Kingdom |
| Brighton | BN1 1RH | United Kingdom |
| London | N2 8AG | United Kingdom |
| London | NW4 3FB | United Kingdom |
| Norwich | NR2 1PB | United Kingdom |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 137 |
| 0 |
| 137 |
| EG001 | Narafilcon A | Spherical daily disposable soft contact lens Class 1 UV blocking narafilcon A: Daily disposable contact lens to be worn at least 8 hours daily | 0 | 138 | 0 | 138 |
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