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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: nelfilcon A contact lens; Other: Spectacles

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9PT
    • Eurolens Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]."	Month 6
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]."	Month 6

Collaborators and Investigators

• Sponsor: CIBA VISION
• Collaborators: University of Manchester
• Investigators: Principal Investigator: Philip Morgan, PhD MCOptom FAAO FBCLA, University of Manchester

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: September 30, 2011
• First Submitted That Met QC Criteria: September 30, 2011
• First Posted (Estimate): October 4, 2011

Study Record Updates

• Last Update Posted (Estimate): September 19, 2013
• Last Update Submitted That Met QC Criteria: September 11, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: P-370-C-091 / CB11-500