A Lifestyle Investigation With Spectacles and Daily Disposable Contact Lenses in Young Patients
- Conditions
- Myopia
- Interventions
- Device: nelfilcon A contact lensOther: Spectacles
- Registration Number
- NCT01445652
- Lead Sponsor
- CIBA VISION
- Brief Summary
The purpose of this study was to evaluate the relative benefits of daily disposable contact lenses versus spectacles in young adults.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description nelfilcon A nelfilcon A contact lens 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 Spectacles Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
- Primary Outcome Measures
Name Time Method Subjective Vision With Correction Type Month 6 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 Happiness With Correction Type Month 6 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
Name Time Method
Trial Locations
- Locations (1)
Eurolens Research
🇬🇧Manchester, United Kingdom