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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01445652
• Other study ID #: P-370-C-091 / CB11-500
• Status: Completed
• Phase: N/A
• First received: September 30, 2011
• Last updated: September 11, 2013
• Start date: September 2011
• Est. completion date: June 2012

Study information

• Verified date: September 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 19 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• nelfilcon A contact lens
Commercially marketed, single vision, soft contact lens for daily disposable wear

Other:
• Spectacles
Spectacles per current prescription

Locations

Country	Name	City	State
United Kingdom	Eurolens Research	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
CIBA VISION	University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No