Evaluation of Monthly Replacement Lenses in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use

NCT ID: NCT05166902

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2022-07-09

Brief Summary

To evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for 1-month.

Detailed Description

This study is a prospective, bilateral eye, double-masked, randomized, 1-month cross-over, daily-wear design involving two different FRP lens types. Each lens type will be worn for approximately one month.

Conditions

Ametropia

Study Design

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

Study Groups

Lens A, Then Lens B

Participants will wear lens A for one month and then cross over to wear lens B for one month.

Group Type: EXPERIMENTAL

Lens A (comfilcon A lens)

Intervention Type: DEVICE

1 month

Lens B (lehfilcon A lens)

Intervention Type: DEVICE

1 month

Lens B, Then Lens A

Participants will wear lens B for one month and then cross over to wear lens A for one month.

Group Type: EXPERIMENTAL

Lens A (comfilcon A lens)

Intervention Type: DEVICE

1 month

Lens B (lehfilcon A lens)

Intervention Type: DEVICE

1 month

Interventions

Lens A (comfilcon A lens)

1 month

Intervention Type: DEVICE

Lens B (lehfilcon A lens)

1 month

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Is at least 18 years of age and no older than 35 years, 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. Self-reports having a full eye examination in the previous two years;

5. Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;

6. Has healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;

7. Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;

8. Habitually wears soft frequent replacement contact lenses, for the past 3 months minimum (NOTE: The habitual contact lens brand was restricted such that no more than one third were to be Biofinity Energys brand (or their equivalent private label brand name) and no more than one third were to be Alcon brand);

9. Has refractive astigmatism no higher than -0.75DC in each eye;

10. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere +6.00 to -6.00D, 0.25D steps).

Exclusion Criteria

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

2. Has any known active ocular disease and/or infection that contraindicates contact lens wear;

3. Has a systemic or ocular 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 contact lens wear or a study outcome variable;

5. Has known sensitivity to the diagnostic sodium fluorescein used in the study;

6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;

7. Has undergone refractive error surgery or intraocular surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre for Ocular Research & Education, Canada

OTHER

Sponsor Role: collaborator

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Wilkinson

Role: PRINCIPAL_INVESTIGATOR

Spadina Optometry

Roxanne Achong-Coan

Role: PRINCIPAL_INVESTIGATOR

Coan Eyecare

Fiona Soong

Role: PRINCIPAL_INVESTIGATOR

Eyes on Sheppard Clinic

Mike Cymbor

Role: PRINCIPAL_INVESTIGATOR

Nittany Eye Associates

Locations

Coan Eye Care

Ocoee, Florida, United States

Nittany Eye Associate

State College, Pennsylvania, United States

Eyes on Sheppard Clinic

Toronto, Ontario, Canada

Spadina Optometry

Toronto, Ontario, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EX-MKTG-130

Identifier Type: -

Identifier Source: org_study_id