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Performance of DAILIES TOTAL1 Daily Disposable Contact Lenses in Habitual Soft Lens Wearers Who Report Substantial Digital Device Use | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT06308666•University of Waterloo

View on ClinicalTrials.gov

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

Age

18 - 40 years

Sex

ALL

Healthy Volunteers

Yes

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;
+4 more criteria

Locations (1)

Centre for Ocular Research & Education

Waterloo, Ontario, Canada

Key Dates

Start Date

March 18, 2024

Primary Completion Date

October 23, 2024

Completion Date

October 23, 2024

Last Updated

October 31, 2025

Enrollment

ACTUAL participants

Conditions

Myopia

Interventions

Delefilcon A contact lenses

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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