Status:
COMPLETED
A Lifestyle Investigation With Spectacles and Daily Disposable Contact Lenses in Young Patients
Lead Sponsor:
CIBA VISION
Collaborating Sponsors:
University of Manchester
Conditions:
Myopia
Eligibility:
All Genders
13-19 years
Phase:
NA
Brief Summary
The purpose of this study was to evaluate the relative benefits of daily disposable contact lenses versus spectacles in young adults.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT01445652
Start Date
September 1 2011
End Date
June 1 2012
Last Update
September 19 2013
Active Locations (1)
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1
Eurolens Research
Manchester, United Kingdom, M13 9PT