Clinical Evaluation of Two Daily Disposable Lenses in Neophytes

The purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of neophytes (new wearers).

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: nelfilcon A contact lens; Device: narafilcon A contact lens

• Study Type: Interventional
• Enrollment (Actual): 326
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Fort Washington, Pennsylvania, United States, 19034
      • The Research Intelligence Group (TRiG)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 45 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• No previous contact lens experience or attempts to try contact lenses (neophytes).
• Currently wearing spectacles or needing vision correction in both eyes.
• No older than 45 years of age.
• Able to achieve visual acuity of at least 20/40 in each eye with study lenses in the available parameters.
• Interested in wearing contact lenses.
• Willing to wear study lenses for at least 8 hours/day, at least 5 days/week.
• 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.
• Previous corneal or refractive surgery.
• Currently enrolled in any Clinical Trial.
• 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
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nelfilcon A; Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.	Device: nelfilcon A contact lens; Commercially marketed, hydrogel, single-vision contact lens for daily wear, daily disposable use.
Active Comparator: narafilcon A; Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.	Device: narafilcon A contact lens; Commercially marketed, silicone hydrogel, single-vision contact lens for daily wear, daily disposable use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Lens Satisfaction	Overall Lens Satisfaction, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being Poor and 10 being Excellent	1 week

Collaborators and Investigators

• Sponsor: CIBA VISION

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: September 29, 2009
• First Submitted That Met QC Criteria: September 30, 2009
• First Posted (Estimate): October 1, 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-031