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

Ciba Vision

Status: Completed

Conditions: Myopia

Treatments: Other: Spectacles; Device: nelfilcon A contact lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01445652

P-370-C-091 / CB11-500

Details and patient eligibility

About

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

Enrollment: 113 patients

Sex: All

Ages: 13 to 19 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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113 participants in 2 patient groups

nelfilcon A

Experimental group

Description:

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

Treatment:

Device: nelfilcon A contact lens

Spectacles

Active Comparator group

Description:

Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months

Treatment:

Other: Spectacles