Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Delefilcon A contact lenses; Device: Narafilcon A contact lenses

• Registration Number: NCT01561560
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this crossover study was to evaluate the end-of-day comfort of two commercially available, daily disposable, silicone hydrogel contact lenses.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-23
• Study Start: 2012-05
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-11
• Results First Submitted: 2013-11-19
• Results First Submitted QC: 2013-11-19
• Last Update Submitted: 2013-11-19
• Results First Posted: 2014-01-07
• Last Update Posted: 2014-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• Sign written Informed Consent Document.
• Currently wearing soft contact lenses in both eyes and identified as symptomatic based on questionnaire responses.
• Currently wearing either daily disposable contact lenses or weekly/monthly replacement contact lenses.
• Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses in the available parameters.
• Willing to wear study lenses for at least eight hours per day and at least five days per week.
• Other protocol-defined inclusion criteria may apply.

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Exclusion Criteria

• Has not worn contact lenses before.
• Currently wearing DAILIES TOTAL1 or 1-DAY ACUVUE TRUEYE contact lenses.
• Any systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
• Ocular surgery/trauma within the last six months.
• Topical ocular or systemic use of antibiotics within seven days of enrollment.
• Pregnant or nursing women.
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TRUEYE, then DAILIES TOTAL1	Narafilcon A contact lenses	Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
DAILIES TOTAL1, then TRUEYE	Delefilcon A contact lenses	Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
DAILIES TOTAL1, then TRUEYE	Narafilcon A contact lenses	Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
TRUEYE, then DAILIES TOTAL1	Delefilcon A contact lenses	Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.

Primary Outcome Measures

Name	Time	Method
End-of-day Comfort	Week 2	End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, "Please rate the study lenses you have been wearing the in the following area: End-of-day comfort" and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent).

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States