Clinical Evaluation of Hydrogel and Silicone Hydrogel Daily Disposable Toric Contact Lenses

CooperVision

Status: Completed

Conditions: Astigmatism

Treatments: Device: Lens A; Device: Lens B

Study type: Interventional

Funder types: Industry

Identifiers

NCT05805085

EX-MKTG-146

Details and patient eligibility

About

This study was to evaluate the patient subjective experiences of two daily disposable toric contact lenses.

Full description

This was a participant masked, interventional, prospective, direct refit, bilateral wear study. The purpose of this study was to evaluate the patient subjective experiences of a hydrogel daily disposable toric contact lens when compared to a silicone hydrogel daily disposable toric contact lens after 15 minutes of daily wear each.

Enrollment: 40 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

A person was eligible for inclusion in the study if he/she:

• Is at least 18 years of age 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, 5 days a week.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Habitual soft contact lens wearers who currently wear toric contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
• Has a contact lens spherical prescription between plano to - 10.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye.
• Has refractive astigmatism no less than -0.75D and no more than 1.75D in both eyes.
• Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
• Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
• Has clear corneas and no active ocular disease.
• Has read, understood, and signed the information consent letter.

Exclusion criteria

A person was excluded from the study if he/she:

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 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Lens A

Experimental group

Description:

Participants wore Lens A for 15 minutes (Period 1)

Treatment:

Device: Lens A

Lens B

Experimental group

Description:

Participants wore Lens B for 15 minutes (Period 2)

Treatment:

Device: Lens B