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OpenTrials
Completed

NCT Number: NCT01445652

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

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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Key information

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurolens Research

Manchester, M13 9PT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nelfilcon A contact lens

Device

Commercially marketed, single vision, soft contact lens for daily disposable wear

Other names: DAILIES AQUACOMFORT PLUS

spectacles

Other

Spectacles per current prescription

Primary outcomes

  1. Subjective Happiness With Correction Type

    Time frame: 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]."

  2. Subjective Vision With Correction Type

    Time frame: 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]."

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Collaborators

  • University of Manchester

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 4, 2011
Registry last updated
Sep 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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