Phase
Condition
Myopia
Treatment
Delefilcon A contact lenses
Clinical Study ID
Ages 18-40 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Are between 18 and 40 years of age (inclusive) and has full legal capacity tovolunteer;
Have read and signed an information consent letter;
Are willing and able to follow instructions and maintain the appointment schedule;
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);
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;
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;
Have a vertex corrected spherical equivalent distance refraction within -0.50Diopter (D) to -9.00D in each eye;
Have a vertex corrected refractive cylinder ≤ -0.75 cylindrical correction in eacheye after vertexing to the corneal plane;
Demonstrate an acceptable fit and achieves best corrected visual acuity of at least 0.10 logMAR in each eye with DAILIES TOTAL1® contact lenses;
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:
Are participating in any concurrent clinical or research study involvingintervention or invasive ocular tests;
Are presbyopic or habitually use a reading addition for close work;
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.]
Meet the diagnosis of dry eye disease as per the following combination:
Meets the symptom criteria of Contact Lens Dry Eye Questionnaire (CLDEQ-8)score ≥12
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.
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.]
Are using any systemic or topical medications that in the opinion of theinvestigator may affect a study outcome variable;
Are a current wearer of DAILIES TOTAL1® daily disposable contact lenses;
Have known sensitivity to the diagnostic pharmaceutical sodium fluorescein to beused in the study;
Have undergone refractive error surgery;
Are a member of the Centre for Ocular Research & Education (CORE) directly involvedin the study.
Study Design
Connect with a study center
Centre for Ocular Research & Education
Waterloo, Ontario N2L 3G1
CanadaSite Not Available


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