A Lifestyle Investigation With Spectacles and Daily Disposable Contact Lenses in Young Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Lifestyle Investigation With Spectacles and Daily Disposable Contact Lenses in Young Patients

Conditions
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Myopia

Intervention / Treatment
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* Device: nelfilcon A contact lens
* Other: Spectacles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Understands rights as a research subject and willing and able to sign a Statement of Informed Consent, or if under 18, parent or guardian understands rights and is willing and able to sign a Statement of Informed Consent. Willing and able to follow the protocol. Currently wearing spectacles full-time (at least five days per week, eight hours per day). Has never worn contact lenses (more than one day) before. Agrees to not participate in other clinical research for the duration of this study. Can attain at least 6/9 in each eye with the study optical correction. Can be fitted with study lenses in the available power range (contact lens group) or can select a satisfactory spectacle lens frame and lenses (spectacle group). Willing and able to wear the study lenses or spectacles for a minimum of five days per week, eight hours per day. Owns or has regular access to a mobile phone and is familiar with SMS text messaging. Has an up-to-date and functional pair of spectacles at time of enrollment. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Has an ocular or systemic disorder that would normally contraindicate contact lens wear. Is using any topical medication such as eye drops or ointment. Has had corneal refractive surgery. Has had cataract surgery. Has diabetes. Has taken part in other clinical research within two weeks of starting the study. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nelfilcon A<br>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 | Device: nelfilcon A contact lens<br>* Commercially marketed, single vision, soft contact lens for daily disposable wear<br>* Other names: DAILIES AQUACOMFORT PLUS;|
| Active Comparator: Spectacles<br>Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months | Other: Spectacles<br>* Spectacles per current prescription<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |