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

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: Lens B (comfilcon A lens); Device: Lens A (lehfilcon A lens)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05333965

EX-MKTG-132

Details and patient eligibility

About

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

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 17+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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26 participants in 2 patient groups

Lens A, Then Lens B

Experimental group

Description:

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

Treatment:

Device: Lens B (comfilcon A lens)

Device: Lens A (lehfilcon A lens)

Lens B, Then Lens A

Experimental group

Description:

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

Treatment:

Device: Lens B (comfilcon A lens)

Device: Lens A (lehfilcon A lens)