Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Lens Wearers

Not Applicable

Completed

• Conditions: Myopia

• Registration Number: NCT00953407
• Lead Sponsor: CIBA VISION

Brief Summary

The purpose of this trial is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of 5 different daily disposable contact lenses.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-08
• Study First Submitted QC: 2009-08-04
• Study First Posted: 2009-08-06
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2010-09-16
• Results First Submitted QC: 2010-10-07
• Results First Posted: 2010-11-01
• Status Verified: 2012-01
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Currently wear spherical, soft contact lenses replaced at intervals of 2 weeks or monthly.
• Habitually wear lenses for at least 8 hours per day, 4 days per week, for at least the past 6 months.
• Report 2 or more qualifying symptoms with current contact lenses with a frequency of "frequently" or "all the time"
• Able to achieve VA of at least 20/40 in each eye with habitual correction and with study lenses at dispense.
• Other protocol 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 medications for which contact lens wear could be contraindicated as determined by the investigator.
• History of corneal refractive surgery.
• Cylinder correction greater than 1.00 D.
• Current monovision contact lens wearers.
• Other protocol inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lens Awareness	4 weeks of wear	Lens awareness, as interpreted by the subject, was reported by the subject 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 all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement.