Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population

Not Applicable

Completed

• Conditions: Myopia

• Registration Number: NCT01007916
• Lead Sponsor: CIBA VISION

Brief Summary

The purpose of this study is to compare the performance of commercially marketed contact lenses to habitual contact lenses in a selected segment of the contact lens wearing population.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-02
• Study First Submitted QC: 2009-11-03
• Study First Posted: 2009-11-05
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Results First Submitted: 2011-01-31
• Results First Submitted QC: 2011-01-31
• Results First Posted: 2011-02-25
• Status Verified: 2012-01
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Habitual spherical soft contact lens wearer who wears a contact lens with a recommended replacement schedule of 2 weeks or monthly.
• Wears lenses at least 5 days per week and at least 12 hours per day.
• Removes contact lenses daily or, if prescribed by their regular eye care practitioner, sleeps overnight in contact lenses no more than 6 consecutive nights.
• Reports 2 or fewer common lens-related symptoms with current contact lenses with a frequency of "frequently" or "always".
• Able to achieve distance visual acuity of at least 20/40 in each eye at the dispense of each pair of study lenses.
• Has acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
• Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria

• Eye injury or surgery within twelve weeks prior to enrollment.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in any clinical trial.
• Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
• Currently sleeping in contact lenses for more than 6 consecutive nights.
• Currently wearing daily disposable contact lenses and certain protocol-specified lens brands.
• Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Comfort Upon Insertion	4 weeks of wear	Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time.