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Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses

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CooperVision

Status

Completed

Conditions

Myopia

Treatments

Device: etafilcon A
Device: somofilcon A

Study type

Interventional

Funder types

Industry

Identifiers

NCT04195893
EX-MKTG-112

Details and patient eligibility

About

The objective of the study is to evaluate and compare the performance of somofilcon A to etafilcon A when worn on a daily disposable wear modality over a period of approximately one week.

Full description

The study is a prospective, double masked (investigator and participant), bilateral, randomized, cross-over dispensing study, which evaluates somofilcon A (test lens) and etafilcon A (control lens).

Enrollment

56 patients

Sex

All

Ages

17+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Subjects will only be eligible for the study if:

    1. Is at least 17 years of age and has full legal capacity to volunteer;

    2. Has read and signed an information consent letter;

    3. Is willing and able to follow instructions and maintain the appointment schedule;

    4. Habitually wears silicone hydrogel frequent replacement soft contact lenses, for minimum of 6-months;

    5. Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;

    6. Can be fit with study contact lenses with a power between - 0.50 and -10.00 DS;

    7. Demonstrates an acceptable fit with the study lenses;

    8. Habitually wears contact lenses for at least 8 hours per day, and willing to wear contact lenses for at least 12 hours a day in the study.

      Exclusion Criteria:

  • Subjects will not be eligible to take part in the study if:

    1. Is participating in any concurrent clinical or research study;
    2. Has any known active* ocular disease and/or infection;
    3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
    4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
    5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
    6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation at the screening visit);
    7. Is aphakic;
    8. Has undergone refractive error surgery;
    9. Is an employee of the Centre for Ocular Research & Education;
    10. Has participated in the BEAGLE (EX-MKTG-104) study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

56 participants in 2 patient groups

somofilcon A
Experimental group
Description:
Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to etafilcon A daily disposable lenses for one week.
Treatment:
Device: somofilcon A
etafilcon A
Active Comparator group
Description:
Subjects will be randomized to wear etafilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week.
Treatment:
Device: etafilcon A

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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