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OpenTrials
Completed

NCT Number: NCT02871375

Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Delefilcon A multifocal contact lenses

Device

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

Other names: DAILIES TOTAL1® multifocal

Habitual multifocal contact lenses

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Alcon, a Novartis Company

Industry

Registry information

Official study title

DAILIES TOTAL1® Multifocal Clinical Assessment in Challenging Patients

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 18, 2016
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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