Evaluating the Performance of Precision1 Daily Disposable Contact Lens in a Group of Heavy Digital Device Users

NCT ID: NCT04201639

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-13
• Study Completion Date: 2021-09-27

Brief Summary

The purpose of this study is to evaluate the performance of Precision1 DD CLs with regard to subjective symptoms (dryness, comfort, vision), lens fit and time to haze in CL wearers who identify themselves as heavy digital devices users (at least 6 hours of digital device use per day).

Conditions

Myopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Refit

Refit and dispense patient with Verofilcon A contact lenses and evaluate lens performance.

Group Type: EXPERIMENTAL

Verofilcon A contact lenses

Intervention Type: DEVICE

Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)

Interventions

Verofilcon A contact lenses

Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)

Intervention Type: DEVICE

Other Intervention Names

Precision1™

Eligibility Criteria

Inclusion Criteria

1. Is between 18 and 40 years of age (inclusive) and has full legal capacity to volunteer;

2. Has read and signed an information consent letter;

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

4. Is a heavy digital device user (at least 6 hours on a typical day using any combination of digital devices such as PC, laptop, smartphone, or tablet);

5. Is a habitual wearer of daily, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision, not a current wearer of Precision1 lenses) for at least 5 days/week and at least 10 hours/day during the month prior to enrollment;

6. Has a vertex corrected spherical equivalent distance refraction that ranges between -0.50D to -6.00D in each eye;

7. Has a vertex corrected refractive cylinder of no more than -1.00D cylindrical correction in each eye after vertexing to the corneal plane;

8. Demonstrates an acceptable fit and achieves best corrected visual acuity of at least 0.20 log MAR in each eye with Precision1 contact lenses;

9. Is willing to wear Precision1 CLs at least 5 days per week and 10 hours per day throughout the study;

Exclusion Criteria

1. Is participating in any concurrent clinical or research study;

2. Has any known active* ocular disease and/or infection;

3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

6. Is pregnant, lactating or planning a pregnancy at the time of enrolment;

7. Is aphakic;

8. Has undergone refractive error surgery;

• 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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

University of Waterloo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lyndon Jones, PhD, FCOptom

Role: PRINCIPAL_INVESTIGATOR

Centre for Ocular Research & Education

Locations

Centre for Ocular Research & Education

Waterloo, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

41694

Identifier Type: -

Identifier Source: org_study_id