Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal

• ClinicalTrials.gov Identifier: NCT02871375
• Recruitment Status: Completed
• First Posted: August 18, 2016
• Results First Posted: November 24, 2017
• Last Update Posted: July 2, 2018
• Sponsor: Alcon, a Novartis Company
• Information provided by (Responsible Party): Alcon Research ( Alcon, a Novartis Company )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Refractive Error	Device: Delefilcon A multifocal contact lenses; Device: Habitual multifocal contact lenses	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 170 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: DAILIES TOTAL1® Multifocal Clinical Assessment in Challenging Patients
• Actual Study Start Date: August 30, 2016
• Actual Primary Completion Date: November 14, 2016
• Actual Study Completion Date: November 14, 2016

Arms and Interventions

Arm	Intervention/treatment
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 Name: DAILIES TOTAL1® multifocal; Device: Habitual multifocal contact lenses; Multifocal contact lenses worn per subject's habitual prescription and habitual daily wear modality
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 Name: DAILIES TOTAL1® multifocal; Device: Habitual multifocal contact lenses; Multifocal contact lenses worn per subject's habitual prescription and habitual daily wear modality

Outcome Measures

Primary Outcome Measures :

1. Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm) [ Time Frame: 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 :

1. Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

Alcon, a Novartis Company

Investigators

• Study Director: Clinical Project Manager, PLS; Alcon, A Novartis Division

More Information

• Responsible Party: Alcon, a Novartis Company
• ClinicalTrials.gov Identifier: NCT02871375
• Other Study ID Numbers: CLE914-P001
• First Posted: August 18, 2016
• Results First Posted: November 24, 2017
• Last Update Posted: July 2, 2018
• Last Verified: October 2017

Keywords provided by Alcon Research ( Alcon, a Novartis Company ):

myopia; presbyopia

Additional relevant MeSH terms:

Refractive Errors; Eye Diseases