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| Name | Class |
|---|---|
| University of Manchester | OTHER |
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The purpose of this study was to evaluate the relative benefits of daily disposable contact lenses versus spectacles in young adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nelfilcon A | Experimental | Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months |
|
| Spectacles | Active Comparator | Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nelfilcon A contact lens | Device | Commercially marketed, single vision, soft contact lens for daily disposable wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Happiness With Correction Type | Participant responded to an SMS message: "Please rate your happiness (H) and vision (V) with your [contact lenses/spectacles]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing [contact lenses/spectacles]." | Month 6 |
| Subjective Vision With Correction Type | Participant responded to an SMS message: "Please rate your happiness (H) and vision (V) with your [contact lenses/spectacles]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing [contact lenses/spectacles]." | Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Morgan, PhD MCOptom FAAO FBCLA | University of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research | Manchester | M13 9PT | United Kingdom |
Of the 113 participants enrolled, 3 were exited as screen failures prior to randomization. This reporting group includes all enrolled and randomized participants (110).
Participants were enrolled from one study center in the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nelfilcon A | Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months |
| FG001 | Spectacles | Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This reporting group includes all enrolled and randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nelfilcon A | Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months |
| BG001 | Spectacles | Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months |
| 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 | Subjective Happiness With Correction Type | Participant responded to an SMS message: "Please rate your happiness (H) and vision (V) with your [contact lenses/spectacles]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing [contact lenses/spectacles]." | This reporting group includes all participants who sent in an SMS response. | Posted | Mean | Standard Deviation | Units on a Scale | Month 6 |
|
Adverse events were collected for the duration of the study (9 months). An adverse event was defined as any unfavourable or unintended sign or symptom associated with the use of a contact lens, but not necessarily caused by the contact lens.
This reporting group includes all enrolled and randomized participants.
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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 lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal inflammatory event | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jami Kern, PhD | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| 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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| Spectacles | Other | Spectacles per current prescription |
|
| Failed teach session |
|
| Adverse Event |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
|
|
| Primary | Subjective Vision With Correction Type | Participant responded to an SMS message: "Please rate your happiness (H) and vision (V) with your [contact lenses/spectacles]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing [contact lenses/spectacles]." | This reporting group includes all participants who sent in an SMS response. | Posted | Mean | Standard Deviation | Units on a scale | Month 6 |
|
|
|
| 0 |
| 57 |
| 4 |
| 57 |
| EG001 | Spectacles | Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months | 0 | 53 | 0 | 53 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.