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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Lens A (lehfilcon A lens); Device: Lens B (comfilcon A lens)

• Registration Number: NCT05333965
• Lead Sponsor: Coopervision, Inc.

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.

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-19
• Study Start: 2022-04-27
• Primary Completion: 2022-09-13
• Study Completion: 2022-09-13
• Results First Submitted: 2023-09-26
• Results First Submitted QC: 2023-10-19
• Last Update Submitted: 2023-10-19
• Results First Posted: 2023-10-23
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lens A, Then Lens B	Lens A (lehfilcon A lens)	Participants wore Lens A for one month and then crossed over to wear Lens B for one month.
Lens B, Then Lens A	Lens B (comfilcon A lens)	Participants wore Lens B for one month and then crossed over to wear Lens A for one month.
Lens B, Then Lens A	Lens A (lehfilcon A lens)	Participants wore Lens B for one month and then crossed over to wear Lens A for one month.
Lens A, Then Lens B	Lens B (comfilcon A lens)	Participants wore Lens A for one month and then crossed over to wear Lens B for one month.

Primary Outcome Measures

Name	Time	Method
Lens Handling on Lens Removal	1 month	Lens handling on removal will be measured on a scale of 0-10, 0.5 steps (0=Completely dissatisfied,10=Completely satisfied)

Trial Locations

Locations (1)

School of Optometry & Vision Science; 🇨🇦 Waterloo, Canada