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Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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