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

• Subjective Happiness with Correction Type [ Time Frame: After 6 months of wear ] [ Designated as safety issue: No ]
  As reported via SMS message. Subjective happiness with correction type will be interpreted and rated by the participant on a 5-point scale, with 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good.
• Subjective Vision with Correction Type [ Time Frame: After 6 months of wear ] [ Designated as safety issue: No ]
  As reported via SMS message. Subjective vision with correction type will be interpreted and rated by the participant on a 5-point scale, with 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good.

The purpose of this study is to evaluate the relative benefits of daily disposable contact lenses versus spectacles in young adults.

This 6-month study seeks to compare the relative benefits of contact lenses and spectacles in subjects aged 13-19 years.

• Device: nelfilcon A contact lens
  Commercially marketed, single vision, soft contact lens for daily disposable wear
  Other Name: DAILIES AQUACOMFORT PLUS
• Other: Spectacles
  Spectacles per current prescription

• Experimental: 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
  Intervention: Device: nelfilcon A contact lens
• Active Comparator: Spectacles
  Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
  Intervention: Other: Spectacles

Inclusion Criteria:

• Between 13 and 19 years, inclusive.
• Understand rights as a research subject and is willing and able to sign a Statement of Informed Consent, or if under 18, a 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.