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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
nelfilcon A contact lens
Spectacles
Sponsored by
CIBA VISION
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eurolens Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

nelfilcon A

Spectacles

Arm Description

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

Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months

Outcomes

Primary Outcome Measures

Subjective Happiness With Correction Type
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
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

Full Information

First Posted
September 30, 2011
Last Updated
September 11, 2013
Sponsor
CIBA VISION
Collaborators
University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT01445652
Brief Title
A Lifestyle Investigation With Spectacles and Daily Disposable Contact Lenses in Young Patients
Official Title
A Lifestyle Investigation With Spectacles and Daily Disposable Contact Lenses in Young Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CIBA VISION
Collaborators
University of Manchester

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nelfilcon A
Arm Type
Experimental
Arm Description
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
Arm Title
Spectacles
Arm Type
Active Comparator
Arm Description
Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
Intervention Type
Device
Intervention Name(s)
nelfilcon A contact lens
Other Intervention Name(s)
DAILIES AQUACOMFORT PLUS
Intervention Description
Commercially marketed, single vision, soft contact lens for daily disposable wear
Intervention Type
Other
Intervention Name(s)
Spectacles
Intervention Description
Spectacles per current prescription
Primary Outcome Measure Information:
Title
Subjective Happiness With Correction Type
Description
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]."
Time Frame
Month 6
Title
Subjective Vision With Correction Type
Description
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]."
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Morgan, PhD MCOptom FAAO FBCLA
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eurolens Research
City
Manchester
ZIP/Postal Code
M13 9PT
Country
United Kingdom

12. IPD Sharing Statement

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

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