Daily Disposable Contact Lens Tear Film Study

• delefilcon A contact lens (Device), also known as DAILIES TOTAL1: CE-marked, silicone hydrogel, single vision, soft contact lens for daily disposable wear
• narafilcon A contact lens (Device), also known as 1-DAY ACUVUE TruEye: Commercially marketed, silicone hydrogel, single vision, soft contact lens for daily disposable wear.

Primary outcomes

• Number of Participants With Corrected Visual Acuity of 0.0 or Better [Up to 16 hours after lens insertion]: 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.
• Pre-Lens Noninvasive Tear Break-Up Time [Up to 16 hours after lens insertion]: 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.
• Average Tear Meniscus Height [Up to 16 hours after lens insertion]: 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.
• Average Ocular Surface Temperature [Up to 16 hours after lens insertion]: 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.

Secondary outcomes

• Subjective Comfort [Up to 16 hours after lens insertion]: 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?"
• Subjective Vision [Up to 16 hours after lens insertion]: 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?"
• Number of Participants With Adequate Lens Fit [Up to 16 hours after lens insertion]: Lens fit was assessed by the investigator with a biomicroscope (slit lamp).

Sex: All, ages: 18 Years to any

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.

Participant flow

Outcome results

• Number of Participants With Corrected Visual Acuity of 0.0 or Better (Primary), Number, participants: Delefilcon A 9 +/- 0.079; Narafilcon A 9 +/- 0.089
• Pre-Lens Noninvasive Tear Break-Up Time (Primary), Mean, seconds: Delefilcon A 12.7 +/- 5.3; Narafilcon A 11.3 +/- 3.5
• Average Tear Meniscus Height (Primary), Mean, pixels: Delefilcon A 28.0 +/- 6.9; Narafilcon A 26.7 +/- 8.2
• Average Ocular Surface Temperature (Primary), Mean, Degrees Celsius: Delefilcon A 35.6 +/- 0.8; Narafilcon A 35.3 +/- 0.8
• Subjective Comfort (Secondary), Mean, Units on a scale: Delefilcon A 9.1 +/- 0.8; Narafilcon A 6.8 +/- 2.3
• Subjective Vision (Secondary), Mean, Units on a scale: Delefilcon A 9.0 +/- 1.3; Narafilcon A 7.8 +/- 1.9
• Number of Participants With Adequate Lens Fit (Secondary), Number, Participants: Delefilcon A 9; Narafilcon A 9

Adverse events

Limitations and caveats: Pilot study. Small number of participants analyzed.