Performance of DAILIES TOTAL1 Daily Disposable Contact Lenses in Habitual Soft Lens Wearers Who Report Substantial Digital Device Use

Last updated: December 4, 2024
Sponsor: University of Waterloo
Overall Status: Completed

Phase

N/A

Condition

Myopia

Treatment

Delefilcon A contact lenses

Clinical Study ID

NCT06308666
46091
  • Ages 18-40
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate the performance of DAILIES TOTAL1 daily disposable contact lenses with regards to subjective symptoms (comfort, dryness, vision) in lens wearers who use identify themselves as substantial digital device users (at least eight hours of digital device use per day).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Are between 18 and 40 years of age (inclusive) and has full legal capacity tovolunteer;

  2. Have read and signed an information consent letter;

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

  4. Are a digital device user (at least 8 hours on a typical day using any combinationof digital devices such as personal computer [PC], laptop, smartphone or tablet);

  5. Are a habitual wearer of daily wear, spherical, soft contact lenses (no bifocal ormultifocal contact lenses, no extended wear or monovision) for at least 5 days/weekand at least 13+ hours/day on a typical day during the month prior to enrolment;

  6. The habitual lens type brand will be restricted such that a maximum of 7participants will be included in the study for each lens brand/material;

  7. Have a vertex corrected spherical equivalent distance refraction within -0.50Diopter (D) to -9.00D in each eye;

  8. Have a vertex corrected refractive cylinder ≤ -0.75 cylindrical correction in eacheye after vertexing to the corneal plane;

  9. Demonstrate an acceptable fit and achieves best corrected visual acuity of at least 0.10 logMAR in each eye with DAILIES TOTAL1® contact lenses;

  10. Are willing to wear DAILIES TOTAL1® contact lenses at least 5 days per week and 13+hours per day throughout the study.

Exclusion

Exclusion Criteria:

  1. Are participating in any concurrent clinical or research study involvingintervention or invasive ocular tests;

  2. Are presbyopic or habitually use a reading addition for close work;

  3. Have any known active* ocular disease and/or infection; [* For the purposes of thisstudy, active ocular disease is defined as infection or inflammation which requirestherapeutic treatment. Mild (i.e. not considered clinically relevant) lidabnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal andconjunctival staining and mild dry eye are not considered active ocular disease.Neovascularization and corneal scars are the result of previous hypoxia, infectionor inflammation and are therefore not active.]

  4. Meet the diagnosis of dry eye disease as per the following combination:

  5. Meets the symptom criteria of Contact Lens Dry Eye Questionnaire (CLDEQ-8)score ≥12

  6. And they show 1 of the following 2 signs:

  • Either sodium fluorescein (NaFl) staining (either [cornea >5 dots] or [conjunctiva >9 dots] or [lid margin >2mm length AND ≥25% width]);
  • Or non-invasive tear film break-up time (NITBUT) (no contact lens) <10seconds.
  1. Have a systemic condition that in the opinion of the investigator may affect a studyoutcome variable;+ [+ Any potential exclusion will be reviewed with the LeadInvestigator or Principal Investigator prior to final decision making.]

  2. Are using any systemic or topical medications that in the opinion of theinvestigator may affect a study outcome variable;

  3. Are a current wearer of DAILIES TOTAL1® daily disposable contact lenses;

  4. Have known sensitivity to the diagnostic pharmaceutical sodium fluorescein to beused in the study;

  5. Have undergone refractive error surgery;

  6. Are a member of the Centre for Ocular Research & Education (CORE) directly involvedin the study.

Study Design

Total Participants: 41
Treatment Group(s): 1
Primary Treatment: Delefilcon A contact lenses
Phase:
Study Start date:
March 18, 2024
Estimated Completion Date:
October 23, 2024

Connect with a study center

  • Centre for Ocular Research & Education

    Waterloo, Ontario N2L 3G1
    Canada

    Site Not Available

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