Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: Delefilcon A contact lenses (DAILIES TOTAL1®)
* Device: Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contact lenses, myopia