A Clinical Performance of Two Soft Toric Contact Lenses

Coopervision, Inc.1 site in 1 country40 target enrollmentSeptember 21, 2022

ConditionsAstigmatism

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Astigmatism
Sponsor: Coopervision, Inc.
Enrollment: 40
Locations: 1
Primary Endpoint: Subjective Overall Score
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study objective was to gather short-term clinical performance data for two soft toric contact lenses.

Detailed Description

This participant-masked, non-randomized, controlled non-dispensing study was to compare the performance of two soft toric lenses. Participants attended one study visit which lasted for approximately 1.5 hours.

Registry

clinicaltrials.gov

Start Date

September 21, 2022

End Date

September 30, 2022

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 of legal age (18) and 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 within the past two years.
•They have ocular astigmatism in both eyes of between 0.75DC and 3.00DC.
•They are expected to be able to be fitted with the study lenses within the power range available.

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 lactating.
•They have an eye or health condition including an immunosuppressive or infectious disease 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 have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Outcomes

Primary Outcomes

Subjective Overall Score

Time Frame: 15 minutes

The subjective overall impression of the contact lens (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Extremely poor, 100=Excellent.