To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear

NCT ID: NCT05333965

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-27
• Study Completion Date: 2022-09-13

Brief Summary

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

Detailed Description

This study will be a prospective, randomized, double-masked, single-site, 1-month cross-over design involving bilateral eye daily wear of two different monthly replacement CL types. Each lens will be worn bilaterally for approximately one month.

Conditions

Myopia

Study Design

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

Study Groups

Lens A, Then Lens B

Participants wore Lens A for one month and then crossed over to wear Lens B for one month.

Group Type: EXPERIMENTAL

Lens A (lehfilcon A lens)

Intervention Type: DEVICE

Daily wear for 1 month.

Lens B (comfilcon A lens)

Intervention Type: DEVICE

Daily wear for 1 month.

Lens B, Then Lens A

Participants wore Lens B for one month and then crossed over to wear Lens A for one month.

Group Type: EXPERIMENTAL

Lens A (lehfilcon A lens)

Intervention Type: DEVICE

Daily wear for 1 month.

Lens B (comfilcon A lens)

Intervention Type: DEVICE

Daily wear for 1 month.

Interventions

Lens A (lehfilcon A lens)

Daily wear for 1 month.

Intervention Type: DEVICE

Lens B (comfilcon A lens)

Daily wear for 1 month.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Is at least 17 years of age and has full legal capacity to volunteer;

2. Self-reports having had a full eye examination within the previous 2 years;

3. Has read and signed an information consent letter;

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

5. Is a habitual wearer of frequent replacement contact lenses;

6. Anticipates no difficulty wearing the contact lenses for 6 days/week and 8 hours/day during the study;

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

8. Can be successfully fit with both study lens types;

9. Achieves at least 0.4 logMAR VA monocularly and at least 0.2 logMAR VA binocularly with each study lens type.

Exclusion Criteria

1. Is participating in any concurrent clinical research study;

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

3. Has an unstable systemic condition that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;

4. Is using any systemic or topical medications in an irregular routine that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;

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

6. Is an employee of the Centre for Ocular Research & Education.

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lyndon Jones, PhD FCOptom

Role: PRINCIPAL_INVESTIGATOR

Centre for Ocular Research and Education

Locations

School of Optometry & Vision Science

Waterloo, , Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EX-MKTG-132

Identifier Type: -

Identifier Source: org_study_id