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

Condition(s): Myopia
NCTId: NCT01445652

Official Title

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

Summary

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

Detailed Description

This 6-month study seeks to compare the relative benefits of contact lenses and spectacles in subjects aged 13-19 years.

Eligibility

Eligibility Criteria

Gender Minimum Age Maximum Age Healthy Volunteers?
Both 13 Years 19 Years False

Inclusion Criteria:

- Between 13 and 19 years, inclusive.

- Understand rights as a research subject and is willing and able to sign a Statement of Informed Consent, or if under 18, a 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.

Interventions & Outcomes

Study Interventions & Types

Device Intervention(s)

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

Other Intervention(s)

Spectacles - Spectacles per current prescription

Study Outcomes

Primary Outcome(s)

Timeframe: After 6 months of wear
Measure: Subjective Happiness with Correction Type
Description: As reported via SMS message. Subjective happiness with correction type will be interpreted and rated by the participant on a 5-point scale, with 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good.
Safety Issue? No

Timeframe: After 6 months of wear
Measure: Subjective Vision with Correction Type
Description: As reported via SMS message. Subjective vision with correction type will be interpreted and rated by the participant on a 5-point scale, with 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good.
Safety Issue? No

Facility Locations

Research Study Facility Map

Map of facility locations for this research study.

Facility is recruiting
Facility is not yet recruiting
Unknown status

Clinical Research Study Facility Locations

Eurolens Research
Manchester, M13 9PT United Kingdom

Related Keywords & Studies

Conditions and Diseases with Related Research Studies

  1. Myopia

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