N/A
Completed N=110
A Lifestyle Investigation With Spectacles and Daily Disposable Contact Lenses in Young Patients
Source: ClinicalTrials.gov NCT01445652 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcomePrimary: Subjective Happiness With Correction Type — 4.92; 4.50 Units on a Scale
Summary
The purpose of this study was to evaluate the relative benefits of daily disposable contact lenses versus spectacles in young adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Happiness With Correction Type |
4.92; 4.50 | — |
| PRIMARY Subjective Vision With Correction Type |
4.5; 4.5 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01445652). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.