Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Delefilcon A contact lenses (DAILIES TOTAL1®); Device: Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)

• Registration Number: NCT01634659
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to compare the subjective performance of DAILIES TOTAL1® daily disposable contact lenses to that of 1-DAY ACUVUE® TruEye® daily disposable contact lenses.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-03
• Study First Posted: 2012-07-06
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Results First Submitted: 2013-09-27
• Results First Submitted QC: 2013-09-27
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-27
• Results First Posted: 2013-11-28
• Last Update Posted: 2013-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• Sign written Informed Consent Document and HIPAA form.
• Be current weekly/monthly replacement contact lens wearer.
• Be willing to not sleep in contact lenses during the study period.
• Require vision correction in both eyes, with a contact lens prescription in protocol-specified power range.
• Have best corrected visual acuity of at least 20/25 in each eye.
• Be willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
• Use re-wetting drops less than once per day and be willing to discontinue use of rewetting drops while wearing the study contact lenses.
• Other protocol-specified inclusion criteria may apply.

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Exclusion Criteria

• Be a neophyte or current wearer of daily disposable lenses.
• Require monovision correction or use multifocal contact lenses.
• Have any systemic or ocular disease or disorder, complicating factor, or structural abnormality that would negatively affect the conduct or outcome of the study.
• Have a history of ocular surgery/trauma within the last 6 months.
• Use topical ocular or systemic antibiotics within 7 days of enrollment.
• Use topical ocular or systemic corticosteroids within 14 days of enrollment, continuing throughout the study.
• Have participated in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
• Have habitually worn contact lenses on an extended wear basis (sleeping in habitual contact lenses for at least 2 nights per week) in the last 3 months prior to enrollment.
• Use re-wetting drops once or more per day.
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Narafilcon B, then delefilcon A	Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)	Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
Delefilcon A, then narafilcon B	Delefilcon A contact lenses (DAILIES TOTAL1®)	Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
Delefilcon A, then narafilcon B	Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)	Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
Narafilcon B, then delefilcon A	Delefilcon A contact lenses (DAILIES TOTAL1®)	Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.

Primary Outcome Measures

Name	Time	Method
Overall Comfort	Day 8	Overall comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.

Secondary Outcome Measures

Name	Time	Method
Overall Quality of Vision	Day 8	Overall quality of vision was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall quality of vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.
End of Day Comfort	Day 8	End of day comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. End of day comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.