Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial was to compare the performance of an investigational daily disposable contact lens to a commercially available daily disposable contact lens.

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Delefilcon A contact lens
* Device: Etafilcon A contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal eyes with no use of ocular medications. Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document. Willing and able to wear spherical contact lenses for protocol-specified timeframe within the available range of powers (-1.00 D to -6.00D in 0.25D steps). Visual acuity with study lenses 20/25 or better. Cylinder less than or equal to 0.75 D. Currently wearing daily disposable lenses. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Anterior segment infection, inflammation, or abnormality. Any active anterior segment ocular disease that would contraindicate contact lens wear. Any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator. History of refractive surgery or irregular cornea. Eye injury within twelve weeks immediately prior to enrollment for this trial. Currently enrolled in any clinical trial. Other protocol-defined exclusion criteria may apply.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Delefilcon A / etafilcon A<br>Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. | Device: Delefilcon A contact lens<br>* Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear<br>* Other names: DAILIES® Total1®;Device: Etafilcon A contact lens<br>* Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear<br>* Other names: 1-DAY ACUVUE® MOIST™;|
| Other: Etafilcon A / delefilcon A<br>Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each. | Device: Delefilcon A contact lens<br>* Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear<br>* Other names: DAILIES® Total1®;Device: Etafilcon A contact lens<br>* Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear<br>* Other names: 1-DAY ACUVUE® MOIST™;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA) | As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity. | 1 week of wear, replacing lenses daily | 
| Overall Comfort | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. | 1 week of wear, replacing lenses daily | 
| Overall Vision Quality | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. | 1 week of wear, replacing lenses daily | 
| Overall Handling | As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy. | 1 week of wear, replacing lenses daily | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Lens Fit | As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. | 1 week of wear, replacing lenses daily |