Daily Disposable Contact Lens Tear Film Study

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the pre-lens tear film stability of a new CE-marked daily disposable contact lens as compared to a commercially available daily disposable contact lens.

Official Title
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DAILIES TOTAL1 Pre-Lens Tear Film Performance - Pilot Trial

Conditions
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Myopia

Intervention / Treatment
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* Device: delefilcon A contact lens
* Device: narafilcon A contact lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be of legal age of consent and sign Informed Consent document. Willing and able to wear spherical contact lenses for 16 hours. Willing and able to wear spherical contact lenses within the available range of powers. Best corrected spectacle visual acuity equal or better than 20/25 or 6/7.5. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Anterior segment infection, inflammation, or abnormality. Any use of systemic medications for which contact lens wear could be contraindicated. History of refractive surgery or irregular cornea. Currently enrolled in any clinical trial. Eye injury within twelve weeks prior to enrollment. 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: delefilcon A<br>Delefilcon A randomly assigned to one eye, with narafilcon A assigned to the fellow eye for contralateral wear. Both products will be worn for one day for 16 hours (+/- 1 hour). | Device: delefilcon A contact lens<br>* CE-marked, silicone hydrogel, single vision, soft contact lens for daily disposable wear<br>* Other names: DAILIES TOTAL1;|
| Active Comparator: narafilcon A<br>Narafilcon A randomly assigned to one eye, with delefilcon A assigned to the fellow eye for contralateral wear. Both products will be worn for one day for 16 hours (+/- 1 hour). | Device: narafilcon A contact lens<br>* Commercially marketed, silicone hydrogel, single vision, soft contact lens for daily disposable wear.<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 |
| --- | --- | --- |
| Number of Participants With Corrected Visual Acuity of 0.0 or Better | Corrected visual acuity was measured with a digitized logMAR (logarithm of the minimum angle of resolution) chart. A logMAR acuity of 0.0 is considered normal distance eyesight. | Up to 16 hours after lens insertion | 
| Pre-Lens Noninvasive Tear Break-Up Time | The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a lengthening in the tear film break up time. | Up to 16 hours after lens insertion | 
| Average Tear Meniscus Height | The tear meniscus height, i.e., the distance between the line of reflection along the top of the tear prism to the edge of the eyelid, was measured by the investigator using a digital slit lamp. | Up to 16 hours after lens insertion | 
| Average Ocular Surface Temperature | Ocular surface temperature (OST) was recorded by the investigator using a dynamic, non-contact, infrared thermography camera. The average OST (encompassing the wear of a contact lens) was taken at the center of the cornea, at the temporal upper limbal area, and over the central 5 mm2 of the cornea, 2 seconds post-blink. | Up to 16 hours after lens insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Comfort | Overall comfort was assessed by the participant and recorded on a scale from 0 (poor) to 10 (excellent) in response to the question, How comfortable is the lens feeling at present? | Up to 16 hours after lens insertion | 
| Subjective Vision | Overall vision was assessed by the participant on scale from 0 (poor) to 10 (excellent) in response to the question, What is the quality of your vision with the lens at present? | Up to 16 hours after lens insertion | 
| Number of Participants With Adequate Lens Fit | Lens fit was assessed by the investigator with a biomicroscope (slit lamp). | Up to 16 hours after lens insertion |