Clinical Evaluation of an Investigational Soft Contact Lens

Study Overview
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Brief Summary
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The purpose of this 4-week dispensing trial is to evaluate and compare an investigational soft contact lens worn on a daily disposable basis with three other soft contact lenses also worn on a daily disposable basis.

Conditions
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Myopia

Intervention / Treatment
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* Device: Delefilcon A contact lens
* Device: Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)
* Device: Nelfilcon A contact lens (DAILIES AquaComfort Plus)
* Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Germany: Be of legal age. USA: Be of legal age or, if under legal age, have written consent of parent/guardian to participate and sign informed assent. Sign Informed Consent. Wear soft contact lenses for at least 3 months prior to the study. Wear soft contact lenses on a daily disposable basis, daily wear basis, or occasional extended wear basis. Other protocol-defined inclusion/exclusion criteria may apply. Exclusion Criteria: Eye injury or surgery within twelve weeks prior to enrollment. Pre-existing ocular irritation that would preclude contact lens fitting. Currently enrolled in any clinical trial. Regularly wear contact lenses on an extended/overnight basis. Germany: pregnant or lactating. Other protocol-defined inclusion/exclusion criteria may apply.
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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delefilcon A<br>Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. | Device: Delefilcon A contact lens<br>* Investigational silicone hydrogel, single vision contact lens for daily wear, daily disposable use<br>* Other names: DAILIES TOTAL1®;|
| Active Comparator: Lotrafilcon B<br>Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. | Device: Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)<br>* Commercially marketed silicone hydrogel, single vision contact lens for daily wear, daily disposable use<br>* Other names: AIR OPTIX®;|
| Active Comparator: Nelfilcon A<br>Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. | Device: Nelfilcon A contact lens (DAILIES AquaComfort Plus)<br>* Commercially marketed hydrogel, single vision contact lens for daily wear, daily disposable use<br>* Other names: DAILIES® AquaComfort Plus®;|
| Active Comparator: Narafilcon A<br>Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks. | Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)<br>* Commercially marketed (Europe) silicone hydrogel, single vision contact lens for daily wear, daily disposable use<br>* Other names: 1-DAY ACUVUE® TRUEYE™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Comfort | Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent. | 4 weeks | 
| Vision Quality During the Day | Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent. | 4 weeks | 
| Overall Handling | Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent. | 4 weeks | 
| Dryness Throughout the Day | Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry. | 4 weeks | 
| Average Daily Wear Time | Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Fit | Lens fit was assessed by the investigator for each eye using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptable loose, 1=acceptable loose, 0=optimal, -1=acceptable tight, and -2=unacceptable tight. | 4 weeks | 
| Corrected Visual Acuity | Corrected visual acuity was tested for each eye while the participant read distant charts in normal lighting. Corrected visual acuity was measured with a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity. | 4 weeks | 
| Overall Satisfaction | Overall satisfaction was recorded on a 5-point Likert scale as a single, retrospective evaluation of 4 weeks of wear. The following scale was used: 2=very satisfied, 1=somewhat satisfied, 0=neither, -1=somewhat dissatisfied, and -2=very dissatisfied. | 4 weeks |