Clinical Evaluation of Two Daily Disposable Lenses in Neophytes

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: nelfilcon A contact lens; Device: narafilcon A contact lens

• Registration Number: NCT00987623
• Lead Sponsor: CIBA VISION

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-09-30
• Study First Posted: 2009-10-01
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2010-12-17
• Results First Submitted QC: 2010-12-17
• Results First Posted: 2011-01-13
• Status Verified: 2012-01
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nelfilcon A	nelfilcon A contact lens	Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
narafilcon A	narafilcon A contact lens	Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.

Primary Outcome Measures

Name	Time	Method
Overall Lens Satisfaction	1 week	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

Trial Locations

Locations (1)

The Research Intelligence Group (TRiG); 🇺🇸 Fort Washington, Pennsylvania, United States