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

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

Primary outcomes

• Subjective Happiness With Correction Type [Month 6]: 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 \[contact lenses/spectacles\]."
• Subjective Vision With Correction Type [Month 6]: 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 \[contact lenses/spectacles\]."

Sex: All, ages: 13 Years to 19 Years

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.

Participant flow

Outcome results

• Subjective Happiness With Correction Type (Primary), Mean, Units on a Scale: Nelfilcon A 4.92 +/- 0.3; Spectacles 4.50 +/- 0.9
• Subjective Vision With Correction Type (Primary), Mean, Units on a scale: Nelfilcon A 4.5 +/- 0.7; Spectacles 4.5 +/- 0.8

Adverse events

Time frame: 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.

Other adverse events by term

• Philip Morgan, PhD MCOptom FAAO FBCLA, Principal investigator, University of Manchester