Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal

NCT ID: NCT02871375

Last Updated: 2018-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-30
• Study Completion Date: 2016-11-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

Delefilcon A multifocal contact lenses

Intervention Type: DEVICE

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

Habitual multifocal contact lenses

Intervention Type: DEVICE

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.

Group Type: OTHER

Delefilcon A multifocal contact lenses

Intervention Type: DEVICE

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

Habitual multifocal contact lenses

Intervention Type: DEVICE

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

Interventions

Delefilcon A multifocal contact lenses

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

Intervention Type: DEVICE

Habitual multifocal contact lenses

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

Intervention Type: DEVICE

Other Intervention Names

DAILIES TOTAL1® multifocal

Eligibility 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;

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;

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon, a Novartis Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Project Manager, PLS

Role: STUDY_DIRECTOR

Alcon, A Novartis Division

Other Identifiers

CLE914-P001

Identifier Type: -

Identifier Source: org_study_id