Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Lens Wearers

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 128
• 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 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 Plan

How is the study designed?

Design Details

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

Number of Arms

5

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
Active Comparator: Etafilcon A; Etafilcon A contact lens	Device: Etafilcon A contact lens; Daily disposable contact lens worn in a daily wear, daily disposable mode
Active Comparator: Omafilcon A; Omafilcon A contact lens	Device: Omafilcon A contact lens; Daily disposable contact lens worn in a daily wear, daily disposable mode
Active Comparator: Hilafilcon B; Hilafilcon B contact lens	Device: Hilafilcon B 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, 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.	4 weeks of wear

Collaborators and Investigators

• Sponsor: CIBA VISION

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: July 8, 2009
• First Submitted That Met QC Criteria: August 4, 2009
• First Posted (Estimate): August 6, 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-027