A Clinical Comparison of Two Soft Contact Lenses (Iteration Under Umbrella Protocol C19-678)

Coopervision, Inc.1 site in 1 country45 target enrollmentNovember 24, 2022

ConditionsMyopia Hyperopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Coopervision, Inc.
Enrollment: 45
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 contact lenses.

Detailed Description

The aim of this subject-masked, non-randomized, controlled non-dispensing study was to evaluate the short-term clinical performance of a monthly sphere contact lens when compared to a daily disposable contact lens after 15 minutes of daily wear each.

Registry

clinicaltrials.gov

Start Date

November 24, 2022

End Date

December 5, 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 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

Subjective overall score was assessed using 0-100 visual analogue scale, where 0=Extremely poor, cannot use lenses and 100=Excellent, highly impressed with these lenses overall