The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses

Coopervision, Inc.3 sites in 1 country55 target enrollmentApril 1, 2022

ConditionsAstigmatism

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Astigmatism
Sponsor: Coopervision, Inc.
Enrollment: 55
Locations: 3
Primary Endpoint: Subjective Handling Rating on Lens Removal
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aimed to compare the clinical performance of two daily disposable toric contact lenses.

Detailed Description

This was a multi-center, randomized, participant-masked, bilateral study controlled by cross-comparison. Participants were assigned to either lens type in random sequence. Lenses were worn on a daily disposable wear schedule. Follow-up visits for each lens were performed after 1 week of wear.

Registry

clinicaltrials.gov

Start Date

April 1, 2022

End Date

May 2, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Coopervision, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•They are at least 18 years old and have the capacity to volunteer.
•They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
•They are willing and able to follow the protocol.
•They currently wear soft contact lenses or have done so in the past two years.
•They have a spherical component of their contact lens prescription between Plano to - 6.00DS (inclusive).
•They have a cylindrical component of their contact lens prescription between -0.75DC and -2.50DC (inclusive).
•They can be satisfactorily fitted with the study lens types.
•At dispensing, they could attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
•They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
•They own a wearable pair of spectacles.

Exclusion Criteria

•They have an ocular disorder which would normally contra-indicate contact lens wear.
•They have a systemic disorder, which would normally contra-indicate contact lens wear.
•They are using any topical medication such as eye drops or ointment.
•They are aphakic.
•They have had corneal refractive surgery.
•They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
•They are pregnant or breastfeeding.
•They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
•They have eye or health conditions including immunosuppressive or infectious diseases, which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
•They are currently wearing one of the study contact lenses.