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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Nelfilcon A contact lens; Device: Narafilcon A contact lens

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nelfilcon A; Nelfilcon A contact lens	Device: Nelfilcon A contact lens; Daily disposable contact lens worn in a daily wear, daily disposable mode
Active Comparator: Narafilcon A; Narafilcon A contact lens	Device: Narafilcon A contact lens; Daily disposable contact lens worn in a daily wear, daily disposable mode

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Awareness	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.	4 weeks of wear

Collaborators and Investigators

• Sponsor: CIBA VISION

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: December 18, 2009
• First Submitted That Met QC Criteria: December 18, 2009
• First Posted (Estimate): December 21, 2009

Study Record Updates

• Last Update Posted (Estimate): July 10, 2012
• Last Update Submitted That Met QC Criteria: June 26, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: P-337-C-030