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

NCT06308666 | Completed Results FDA Device

• 1 other identifier: 46091
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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).

Conditions

Myopia

Outcome Measures

Primary Outcomes (3)

• Subjective Rating of Comfort After 8 Hours or More of Digital Device Use

  Participants rate their overall comfort after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best).

  Day 14+2

• Subjective Rating of Dryness After 8 Hours or More of Digital Device Use

  Participants rate their overall dryness after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best).

  Day 14+2

• Subjective Rating of Clarity of Vision After 8 Hours or More of Digital Device Use

  Participants rate their overall clarity of vision after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best).

  Day 14+2

Study Arms (1)

Refit

EXPERIMENTAL

Refit and dispense participant with delefilcon A contact lenses and evaluate lens performance

Device: Delefilcon A contact lenses

Interventions

Delefilcon A contact lenses DEVICE

Daily disposable silicone hydrogel contact lenses indicated for the optical correction of myopia and hyperopia

Also known as: DAILIES TOTAL1®

Refit

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are between 18 and 40 years of age (inclusive) and has full legal capacity to volunteer;
• 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 combination of digital devices such as personal computer \[PC\], laptop, smartphone or tablet);
• 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;
• 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;
• Have a vertex corrected spherical equivalent distance refraction within -0.50 Diopter (D) to -9.00D in each eye;
• Have a vertex corrected refractive cylinder ≤ -0.75 cylindrical correction in each eye 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.

You may not qualify if:

• Are participating in any concurrent clinical or research study involving intervention or invasive ocular tests;
• Are presbyopic or habitually use a reading addition for close work;
• Have any known active\* ocular disease and/or infection; \[\* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and mild dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.\]
• 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) \<10 seconds.
• Are using any systemic or topical medications that in the opinion of the investigator 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 be used in the study;
• Have undergone refractive error surgery;
• Are a member of the Centre for Ocular Research \& Education (CORE) directly involved in the study.

Sponsors & Collaborators

• University of Waterloo: lead
• Alcon Research: collaborator

Study Sites (1)

Centre for Ocular Research & Education

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jill Woods
• Organization: Centre for Ocular Research and Education

jwoods@uwaterloo.ca

(519) 888-4567

Study Officials

• Lyndon Jones, PhD, FCOptom

  Centre for Ocular Research & Education

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: March 18, 2024
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: October 31, 2025
• Results First Posted: October 31, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)