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

Not Applicable
Completed
Conditions
Myopia
Interventions
Device: nelfilcon A contact lens
Other: Spectacles
Registration Number
NCT01445652
Lead Sponsor
CIBA VISION
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
113
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
nelfilcon Anelfilcon A contact lensNelfilcon 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
SpectaclesSpectaclesSpectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
Primary Outcome Measures
NameTimeMethod
Subjective Vision With Correction TypeMonth 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 Happiness With Correction TypeMonth 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 \[contact lenses/spectacles\]."

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Eurolens Research

🇬🇧

Manchester, United Kingdom

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