Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal

Alcon

Status: Completed

Conditions: Refractive Error

Treatments: Device: Delefilcon A multifocal contact lenses; Device: Habitual multifocal contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT02871375

CLE914-P001

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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170 participants in 2 patient groups

DT1 MF, then Habitual

Other group

Description:

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.

Treatment:

Device: Habitual multifocal contact lenses

Device: Delefilcon A multifocal contact lenses

Habitual, then DT1 MF

Other group

Description:

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.

Treatment:

Device: Habitual multifocal contact lenses

Device: Delefilcon A multifocal contact lenses