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

NCT01445652 | Completed Results

• 1 other identifier: P-370-C-091 / CB11-500
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

nelfilcon A

EXPERIMENTAL

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

Spectacles

ACTIVE COMPARATOR

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

Other: Spectacles

Interventions

nelfilcon A contact lens DEVICE

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

Also known as: DAILIES AQUACOMFORT PLUS

nelfilcon A

Spectacles OTHER

Spectacles per current prescription

Spectacles

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CIBA VISION: lead
• University of Manchester: collaborator

Study Sites (1)

Eurolens Research

Manchester, M13 9PT, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Jami Kern, PhD
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Philip Morgan, PhD MCOptom FAAO FBCLA

  University of Manchester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 4, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 19, 2013
• Results First Posted: September 9, 2013

Record last verified: 2013-09

Locations

GB (1)