Evaluating the Initial Lens Handling Experience of Neophyte Contact Lens Wearers Fitted With Precision1 and 1-Day Acuvue Moist Contact Lenses

NCT ID: NCT04205162

Last Updated: 2023-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-13
• Study Completion Date: 2022-06-02

Brief Summary

The initial subjecting handling experience of neophyte contact lens wearers with Precision1 will be compared to that with a daily disposable lens which mas been on the market for numerous years (1-Day ACUVUE Moist).

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Verofilcon A / Etafilcon A

The participant will wear Verofilcon A in their right eye and Etafilcon A in their left eye.

Group Type: EXPERIMENTAL

Verafilcon A

Intervention Type: DEVICE

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

Etafilcon A

Intervention Type: DEVICE

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

Etafilcon A / Verofilcon A

The participant will wear Etafilcon A in their right eye and Verafilcon A in their left eye.

Group Type: EXPERIMENTAL

Verafilcon A

Intervention Type: DEVICE

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

Etafilcon A

Intervention Type: DEVICE

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

Interventions

Verafilcon A

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

Intervention Type: DEVICE

Etafilcon A

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

Intervention Type: DEVICE

Other Intervention Names

Precision1™; Acuvue® Moist

Eligibility Criteria

Inclusion Criteria

1. Is between 18 and 40 years of age inclusively 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 neophyte who has no history of any previous contact lens handling experience;

5. Has a refraction cyl ≤1.00DC in either eye (after vertexing to corneal plane);

6. Has visual acuity ≤0.20 logMAR each eye with study lenses;

7. Demonstrates acceptable fit with study lenses;

8. Demonstrates the ability to successfully insert and remove the study lenses 3 times for each eye (contralateral CL handling, so that each lens type inserted and removed 3x on same eye);

9. Is willing to wear study CLs at least 5 days per week and 6 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 (by self-report);

7. Is aphakic;

8. Has undergone refractive error surgery;

9. Has taken part in another clinical research study within the last 14 days;

10. Any ocular and/or systemic conditions or concomitant medication to contraindicate contact lens wear or be expected to interfere with the primary outcome variables.

• 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

41693

Identifier Type: -

Identifier Source: org_study_id