Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal

NCT02871375 | Completed Results

• 1 other identifier: CLE914-P001
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Refractive Error

Keywords

myopia; presbyopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score

  Day 14, each product

Study Arms (2)

DT1 MF, then Habitual

OTHER

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; Device: Habitual multifocal contact lenses

Habitual, then DT1 MF

OTHER

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; Device: Habitual multifocal contact lenses

Interventions

Delefilcon A multifocal contact lenses DEVICE

Multifocal contact lenses worn in a daily wear, daily disposable modality (new pair of lenses each morning)

Also known as: DAILIES TOTAL1® multifocal

DT1 MF, then Habitual; Habitual, then DT1 MF

Habitual multifocal contact lenses DEVICE

Multifocal contact lenses worn per subject's habitual prescription and habitual daily wear modality

DT1 MF, then Habitual; Habitual, then DT1 MF

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon, a Novartis Company: lead

MeSH Terms

Conditions

Refractive Errors; Myopia; Presbyopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Franchise Head, Vision Care
• Organization: Alcon, A Novartis Division

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Project Manager, PLS

  Alcon, A Novartis Division

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 18, 2016
• Study Start: August 30, 2016
• Primary Completion: November 14, 2016
• Study Completion: November 14, 2016
• Last Updated: July 2, 2018
• Results First Posted: November 24, 2017

Record last verified: 2017-10