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

This study has been completed.
Sponsor:
Collaborator:
University of Manchester
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01445652
First received: September 30, 2011
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention
Myopia
Device: nelfilcon A contact lens
Other: Spectacles

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Lifestyle Investigation With Spectacles and Daily Disposable Contact Lenses in Young Patients

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Subjective Happiness With Correction Type [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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]."


Enrollment: 113
Study Start Date: September 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: nelfilcon A contact lens
Commercially marketed, single vision, soft contact lens for daily disposable wear
Other Name: DAILIES AQUACOMFORT PLUS
Active Comparator: Spectacles
Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
Other: Spectacles
Spectacles per current prescription

  Eligibility

Ages Eligible for Study:   13 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445652

Locations
United Kingdom
Eurolens Research
Manchester, United Kingdom, M13 9PT
Sponsors and Collaborators
CIBA VISION
University of Manchester
Investigators
Principal Investigator: Philip Morgan, PhD MCOptom FAAO FBCLA University of Manchester
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01445652     History of Changes
Other Study ID Numbers: P-370-C-091 / CB11-500
Study First Received: September 30, 2011
Results First Received: June 28, 2013
Last Updated: September 11, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014