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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 22, 2014