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

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

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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