Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers

Not Applicable

Completed

• Conditions: Dry Eye Syndrome; Myopia
• Interventions: Device: Nelfilcon A contact lenses

• Registration Number: NCT01614600
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to evaluate the reduction of contact lens-related dryness symptoms when symptomatic weekly/monthly contact lens wearers were switched to DAILIES® AquaComfort Plus® lenses for a two-week period using composite scores on the Contact Lens Dry Eye Questionnaire (CLDEQ).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-06
• Study First Submitted QC: 2012-06-06
• Study First Posted: 2012-06-08
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-09
• Results First Submitted: 2013-09-27
• Results First Submitted QC: 2013-09-27
• Last Update Submitted: 2013-09-27
• Results First Posted: 2013-12-04
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Currently wearing weekly/monthly, silicone hydrogel or traditional hydrogel soft contact lenses at least 8 hours per day and 5 days a week during the past 6 months.
• Identified as symptomatic using a baseline screening questionnaire.
• Requires vision correction in both eyes with a contact lens prescription as follows: sphere powers between -0.50 and -10.00 diopter (D) and cylinder powers </= 0.75D and no ADD correction.
• Able to achieve visual acuity (VA) of at least 6/7.5 in each eye with study lenses in the available parameters.
• Willing to wear study lenses for at least 8 hours/day and at least 5 days/week and discard the lenses at the end of the day and replace lenses every day with a new fresh pair.
• Willing and able to follow instructions and maintain the appointment schedule.
• Other protocol-defined inclusion criteria may apply.

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Exclusion Criteria

• Neophytes and current wearers of daily disposable contact lenses.
• Requires monovision correction.
• Any systemic or ocular disease or disorder (refractive disorder allowed) complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
• A history of ocular surgery/trauma within the last 6 months.
• Unwilling to discontinue mechanical eyelid therapy or eyelid scrubs within 14 days of enrollment and continuing during the study.
• Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DAILIES® AquaComfort Plus®	Nelfilcon A contact lenses	Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2	Baseline, Week 1, Week 2	Contact lens symptoms were evaluated using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects rated 8 common contact lens-related ocular surface dryness symptoms at Baseline, Week 1, and Week 2 using a 5-point scale (1=never or not at all intense, 5=constantly or very intense). A scoring algorithm was used to calculate a composite score for each visit for all symptoms (-6.5 to 10). A higher composite score would indicate more contact lens related dry eye and a lower score, less contact lens related dry eye.