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Multifocal Visual Performance Study

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ClinicalTrials.gov Identifier: NCT03757039
Recruitment Status : Terminated (Management Decision)
First Posted : November 28, 2018
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this trial is to compare the functional visual performance of Precision Profile Multifocal (MF) contact lenses to Progressive Addition Lens (PAL) spectacles in a presbyopic population.

Condition or disease Intervention/treatment Phase
Presbyopia Device: Multifocal soft contact lenses Other: Progressive addition lens spectacles Not Applicable

Detailed Description:
Habitual contact lens wearers will be randomized to one of three commercially available MF contact lenses. Progressive addition lens wearers will wear their habitual spectacles. Subjects will be expected to attend 1 or 2 office visits.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: This will be a double-masked trial for the contact lens wearers. The PAL wearers are not masked.
Primary Purpose: Treatment
Official Title: Multifocal Visual Performance Study - Seamless Transition With Precision Profile MF Lenses
Actual Study Start Date : December 16, 2018
Actual Primary Completion Date : March 6, 2019
Actual Study Completion Date : March 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Multifocal Contact Lenses
Multifocal soft contact lenses according to the subject's prescription and fitted using the Alcon MF fitting guide. Lenses will be worn bilaterally (in both eyes) for up to 3 hours, 1 day only.
Device: Multifocal soft contact lenses
Commercially available contact lenses
Other Names:
  • DAILIES TOTAL1® Multifocal contact lenses
  • DAILIES® AquaComfort Plus® Multifocal contact lenses
  • AIR OPTIX® plus HydraGlyde® Multifocal contact lenses

Active Comparator: PAL Spectacles
Progressive addition lens spectacles according to the subject's habitual prescription, with testing up to 3 hours, 1 day only.
Other: Progressive addition lens spectacles
Per subject's habitual prescription
Other Name: PAL




Primary Outcome Measures :
  1. Average transition time during alternate distance (4 m) and intermediate (80 cm) viewing [ Time Frame: Time to Event (Day 1, up to 3 hours) ]
    The subject will be asked to read text at distance (4 meters from the subject), followed immediately by text at intermediate (80 centimeters from the subject) and start reading when the text becomes clear. The interval (milliseconds) between when the subject stops reading the distance text and starts reading the text at intermediate is defined as the transition time.



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Ages Eligible for Study:   38 Years to 58 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Normal eyes, other than correction for refractive error;
  • Habitual correction of either any multifocal contact lens with a maximum add of +2.00 Diopter (D), or progressive addition lens spectacles with a maximum add of +2.00D;
  • Wears habitual correction at least 5 days per week and at least 6 hours per day.

Exclusion Criteria:

  • Monocular subjects;
  • Subjects fit with only one contact lens;
  • Known pregnancy or lactating;
  • History of or planned refractive surgery or irregular cornea in either eye.

Other protocol-specified inclusion and/or 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): NCT03757039


Locations
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United States, Texas
Alcon Investigative Site
Houston, Texas, United States, 77204-2020
United Kingdom
Alcon Investigative Site
Birmingham, United Kingdom, B4 7ET
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Senior Clinical Manager, CDMA Alcon, a Novartis Division

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT03757039     History of Changes
Other Study ID Numbers: CLT792-P001
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Alcon Research:
contact lenses
multifocal
spectacles
glasses
progressive
vision
eyes
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases