Clinical trial NCT06308666: Performance of DAILIES TOTAL1 Daily Disposable Contact Lenses in Habitual Soft Lens Wearers Who Report Substantial Digital Device Use
Official title: Performance of DAILIES TOTAL1 Daily Disposable Contact Lenses in Habitual Soft Lens Wearers Who Report Substantial Digital Device Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2024-03-13
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 Criteria:

1. Are between 18 and 40 years of age (inclusive) and has full legal capacity to volunteer;
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 combination of 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 or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and 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 7 participants will be included in the study for each lens brand/material;
7. Have a vertex corrected spherical equivalent distance refraction within -0.50 Diopter (D) to -9.00D in each eye;
8. Have a vertex corrected refractive cylinder ≤ -0.75 cylindrical correction in each eye 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 Criteria:

1. Are participating in any concurrent clinical or research study involving intervention 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; \[\* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and mild dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.\]
4. Meet the diagnosis of dry eye disease as per the following combination:

   1. Meets the symptom criteria of Contact Lens Dry Eye Questionnaire (CLDEQ-8) score ≥12
   2. 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) \<10 seconds.
5. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;+ \[+ Any potential exclusion will be reviewed with the Lead Investigator or Principal Investigator prior to final decision making.\]
6. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
7. Are a current wearer of DAILIES TOTAL1® daily disposable contact lenses;
8. Have known sensitivity to the diagnostic pharmaceutical sodium fluorescein to be used in the study;
9. Have undergone refractive error surgery;
10. Are a member of the Centre for Ocular Research \& Education (CORE) directly involved in the study.

Primary outcomes:
measure: Subjective Rating of Comfort After 8 Hours or More of Digital Device Use
timeFrame: Day 14+2
measure: Subjective Rating of Dryness After 8 Hours or More of Digital Device Use
timeFrame: Day 14+2
measure: Subjective Rating of Clarity of Vision After 8 Hours or More of Digital Device Use
timeFrame: Day 14+2
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Ocular Research & Education
state: Ontario
Study officials:
affiliation: Centre for Ocular Research & Education
name: Lyndon Jones, PhD, FCOptom
role: PRINCIPAL_INVESTIGATOR
References: