Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers

CooperVision International Limited (CVIL)5 sites in 2 countries50 target enrollmentAugust 18, 2023

ConditionsAstigmatism

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Astigmatism
Sponsor: CooperVision International Limited (CVIL)
Enrollment: 50
Locations: 5
Primary Endpoint: Lens Handling on Removal
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of the study was to compare the clinical performance of two monthly toric silicone hydrogel contact lenses in habitual wearers, when worn for 1-month each.

Detailed Description

This study was a prospective, bilateral eye, subjected-masked, randomized, 1-month cross-over, daily-wear design involving two different silicone hydrogel toric lens types. Each lens type will be worn bilaterally for approximately one month.

Registry

clinicaltrials.gov

Start Date

August 18, 2023

End Date

December 28, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

CooperVision International Limited (CVIL)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Is between 18 and 39 years of age (inclusive) and has full legal capacity to volunteer;
•Has read and signed an information consent letter;
•Self-reports having a full eye examination in the previous two years;
•Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;
•Is willing and able to follow instructions and maintain the appointment schedule;
•Habitually wears of toric soft contact lenses binocularly.
•No more than 1/3 of the participants should be wearing daily disposable soft toric lenses;
•the remaining 2/3+ of the participants must be planned frequent replacement soft toric lens wearers as follows:
•i. TOTAL30 for Astigmatism: maximum of 3 (∼10%) (no target percentage)
•ii. Biofinity toric: maximum of 13 (∼40%) (PLUS a target of minimum 10 (∼30%))

Exclusion Criteria

•Is participating in any concurrent clinical or research study;
•Has any known active ocular disease and/or infection that contraindicates contact lens wear;
•Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
•Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
•Has known sensitivity to the diagnostic sodium fluorescein used in the study;
•Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
•Has undergone refractive error surgery or intraocular surgery.