Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal

Not Applicable

Completed

Interventions: Device: Delefilcon A multifocal contact lenses
Device: Habitual multifocal contact lenses

Brief Summary: The purpose of this study is to evaluate DAILIES TOTAL1® Multifocal (DTl MF) contact lenses in current multifocal contact lens wearers with symptoms of end of day discomfort compared to their habitual multifocal contact lens correction.

Recruitment & Eligibility

Inclusion Criteria

Must sign an informed consent document;
Current daily wearer of soft multifocal contact lenses for at least 6 months with symptoms of contact lens discomfort as defined by the prescreening Eligibility Questionnaire;
Requires a near spectacle add of +0.50 to +2.50 diopters (D) (inclusive);
Requires lenses within the power range of study lenses to be fitted;
Best corrected VA (BCVA) of 20/30 (0.2 logarithmic minimum angle of resolution [logMAR]) or better in each eye at distance;
Willing to wear study lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

Any eye condition that contraindicates wearing contact lenses as determined by the Investigator;
Any use of medications for which contact lens wear could be contraindicated, as determined by the Investigator;
Monocular (only one eye functional) or fit with only 1 lens;
Fitted with monovision;
Prior refractive surgery (e.g., laser vision correction, photorefractive keratectomy, etc.);
History of herpetic keratitis, ocular surgery, or irregular cornea;
Currently wearing DT1 MF contact lenses;
Other protocol-defined exclusion criteria may apply.

Arm && Interventions

Group	Intervention	Description
DT1 MF, then Habitual	Habitual multifocal contact lenses	Delefilcon A multifocal contact lenses in Period 1, followed by subject's habitual multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
DT1 MF, then Habitual	Delefilcon A multifocal contact lenses	Delefilcon A multifocal contact lenses in Period 1, followed by subject's habitual multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
Habitual, then DT1 MF	Habitual multifocal contact lenses	Subject's habitual multifocal contact lenses in Period 1, followed by delefilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
Habitual, then DT1 MF	Delefilcon A multifocal contact lenses	Subject's habitual multifocal contact lenses in Period 1, followed by delefilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.

Primary Outcome Measures

Name	Time	Method
Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm)	Day 14, each product	Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HC/HI VA was assessed binocularly (both eyes together) at 80 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity.

Secondary Outcome Measures

Name	Time	Method
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score	Day 14, each product	The abbreviated CLDEQ-8 is an 8-item questionnaire used to assess comfort and dryness. Total CLDEQ-8 score ranged from 0 to 37, where a lower score represented less symptomology.