The trial is taking place at:
P

ProCare Vision Center | Granville, OH

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Performance Comparison of Two Monthly Replacement Silicone Hydrogel Multifocal Lens Types

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CooperVision

Status

Enrolling

Conditions

Presbyopia

Treatments

Device: Control Lens (comfilcon A)
Device: Test Lens (lehfilcon A)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06232590
EX-MKTG-153

Details and patient eligibility

About

To evaluate and compare the performance of two monthly replacement multifocal contact lenses in existing wearers.

Full description

This is a prospective, randomized, participant-masked, crossover, bilateral dispensing study. Each lens type will be worn for approximately 4-6 weeks: the lens prescription of each lens type will be optimized after 3-10 days wearing experience, prior to starting a 1-month (28-32 days) wear period.

Enrollment

60 estimated patients

Sex

All

Ages

42+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Is at least 42 years of age and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Self reports having a full eye examination in the previous two years;
  • Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week;
  • Is willing and able to follow instructions and maintain the appointment schedule;

Habitually wears spherical multifocal soft contact lenses, for the past 3 months minimum;

  • Maximum of 4 participants (out of 12) per site may be habitual wearers of daily disposable lenses,
  • Maximum of 4 participants (out of 12) per site may be habitual wearers of Biofinity Multifocal,
  • Maximum of 4 participants (out of 12) per site may be habitual wearers of either TOTAL30 Multifocal or AirOptix plus HydraGlyde Multifocal
  • Has refractive astigmatism no higher than -0.75DC;
  • Is presbyopic and requires a reading addition of at least +0.75D and no more than +2.50D;
  • Can be fit and achieve binocular distance vision of at least 20/30 Snellen which participants also deem to be 'acceptable', with the available study lens parameters (Distance sphere +4 to -6; near addition as per study design).

Exclusion criteria

  • Is participating in any concurrent clinical or research trial;
  • Has any known active ocular disease and/or infection that contraindicates contact lens wear;
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  • Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
  • Has known sensitivity to the diagnostic sodium fluorescein used in the study;
  • Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
  • Has undergone refractive error surgery or intraocular surgery.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

60 participants in 2 patient groups

Control Lens, then Test Lens
Experimental group
Description:
Participants will wear the Control Lens for 1 month, then the Test Lens for 1 month
Treatment:
Device: Test Lens (lehfilcon A)
Device: Control Lens (comfilcon A)
Test Lens, then Control Lens
Experimental group
Description:
Participants will wear the Test Lens for 1 month, then the Control Lens for 1 month
Treatment:
Device: Test Lens (lehfilcon A)
Device: Control Lens (comfilcon A)

Trial contacts and locations

5

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Central trial contact

José A Vega, OD PhD FAAO

Data sourced from clinicaltrials.gov

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