Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Delefilcon A contact lenses (DAILIES TOTAL1®); Device: Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Delefilcon A, then narafilcon B; 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.	Device: Delefilcon A contact lenses (DAILIES TOTAL1®); Commercially marketed silicone hydrogel, single-vision contact lenses for daily wear, daily disposable use; Device: Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®); Commercially marketed, silicone hydrogel single-vision contact lenses for daily wear, daily disposable use
Other: Narafilcon B, then delefilcon A; 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.	Device: Delefilcon A contact lenses (DAILIES TOTAL1®); Commercially marketed silicone hydrogel, single-vision contact lenses for daily wear, daily disposable use; Device: Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®); Commercially marketed, silicone hydrogel single-vision contact lenses for daily wear, daily disposable use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Comfort	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.	Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Quality of Vision	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.	Day 8
End of Day Comfort	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.	Day 8

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Jami Kern, MBA, PhD, Alcon Research

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: July 3, 2012
• First Submitted That Met QC Criteria: July 3, 2012
• First Posted (Estimate): July 6, 2012

Study Record Updates

• Last Update Posted (Estimate): December 24, 2013
• Last Update Submitted That Met QC Criteria: November 27, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: contact lenses; myopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: M-12-033