Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Narafilcon A contact lens; Device: Nelfilcon A contact lens

• Registration Number: NCT01035905
• Lead Sponsor: CIBA VISION

Brief Summary

The purpose of this study is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of two different daily disposable contact lenses.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2009-11
• Study Completion: 2009-12
• Study First Submitted: 2009-12-18
• Study First Submitted QC: 2009-12-18
• Study First Posted: 2009-12-21
• Results First Submitted: 2010-09-27
• Results First Submitted QC: 2010-09-27
• Results First Posted: 2010-10-19
• Status Verified: 2012-01
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Currently wear daily disposable, spherical, soft lens wearers (except the two study products) for at least the past 6 months.
• Habitually wear lenses for at least 8 hours per day and 4 days per week.
• Report 2 or more qualifying symptoms with current contact lenses.
• Able to achieve visual acuity of at least 20/40 in each eye with habitual and with study lenses at dispense.
• Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria

• Eye injury or surgery within twelve weeks immediately prior to enrollment.
• Currently enrolled in any clinical trial.
• Any use of ocular medications, exclusive of contact lens rewetting drops.
• History of corneal or refractive surgery.
• Cylinder correction greater than 1.00 D
• Current monovision contact lens wearers.
• Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Narafilcon A	Narafilcon A contact lens	Narafilcon A contact lens
Nelfilcon A	Nelfilcon A contact lens	Nelfilcon A contact lens

Primary Outcome Measures

Name	Time	Method
Lens Awareness	4 weeks of wear	Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire as a single, retrospective evaluation of 4-week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement.