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Clinical Assessment of DAILIES TOTAL1® (DT1) Multifocal

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ClinicalTrials.gov Identifier: NCT02871375
Recruitment Status : Completed
First Posted : August 18, 2016
Results First Posted : November 24, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( Alcon, a Novartis Company )

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.

Condition or disease Intervention/treatment Phase
Refractive Error Device: Delefilcon A multifocal contact lenses Device: Habitual multifocal contact lenses Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: DAILIES TOTAL1® Multifocal Clinical Assessment in Challenging Patients
Actual Study Start Date : August 30, 2016
Actual Primary Completion Date : November 14, 2016
Actual Study Completion Date : November 14, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: Delefilcon A multifocal contact lenses
Multifocal contact lenses worn in a daily wear, daily disposable modality (new pair of lenses each morning)
Other Name: DAILIES TOTAL1® multifocal

Device: Habitual multifocal contact lenses
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.
Device: Delefilcon A multifocal contact lenses
Multifocal contact lenses worn in a daily wear, daily disposable modality (new pair of lenses each morning)
Other Name: DAILIES TOTAL1® multifocal

Device: Habitual multifocal contact lenses
Multifocal contact lenses worn per subject's habitual prescription and habitual daily wear modality




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871375


Sponsors and Collaborators
Alcon, a Novartis Company
Investigators
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Study Director: Clinical Project Manager, PLS Alcon, A Novartis Division

Additional Information:
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Responsible Party: Alcon, a Novartis Company
ClinicalTrials.gov Identifier: NCT02871375     History of Changes
Other Study ID Numbers: CLE914-P001
First Posted: August 18, 2016    Key Record Dates
Results First Posted: November 24, 2017
Last Update Posted: July 2, 2018
Last Verified: October 2017
Keywords provided by Alcon Research ( Alcon, a Novartis Company ):
myopia
presbyopia
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases