Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal

DAILIES TOTAL1® Multifocal Clinical Assessment in Challenging Patients

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.

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: Delefilcon A multifocal contact lenses; Device: Habitual multifocal contact lenses

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DT1 MF, then Habitual; 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.	Device: Delefilcon A multifocal contact lenses; Multifocal contact lenses worn in a daily wear, daily disposable modality (new pair of lenses each morning); Other Names: DAILIES TOTAL1® multifocal; Device: Habitual multifocal contact lenses; Multifocal contact lenses worn per subject's habitual prescription and habitual daily wear modality
Other: Habitual, then DT1 MF; 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.	Device: Delefilcon A multifocal contact lenses; Multifocal contact lenses worn in a daily wear, daily disposable modality (new pair of lenses each morning); Other Names: DAILIES TOTAL1® multifocal; Device: Habitual multifocal contact lenses; Multifocal contact lenses worn per subject's habitual prescription and habitual daily wear modality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm)	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.	Day 14, each product

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score	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.	Day 14, each product

Collaborators and Investigators

• Sponsor: Alcon, a Novartis Company
• Investigators: Study Director: Clinical Project Manager, PLS, Alcon, A Novartis Division

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2016
• Primary Completion (Actual): November 14, 2016
• Study Completion (Actual): November 14, 2016

Study Registration Dates

• First Submitted: August 15, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (Estimate): August 18, 2016

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: presbyopia; myopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLE914-P001