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

Coopervision, Inc.1 site in 1 country50 target enrollmentDecember 11, 2023

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Coopervision, Inc.
Enrollment: 50
Locations: 1
Primary Endpoint: Subjective Overall Score
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study was designed to gather short-term clinical performance data for 2 soft contact lenses.

Detailed Description

The purpose of this participant-masked, non-randomized, crossover controlled, non-dispensing, study was to compare the short-term performance of 2 daily disposable contact lenses after 15 minutes of daily wear each. The lenses were identical in all aspects except for diameter. Participants attended for 1 visit only which lasted for approximately 2 hours.

Registry

clinicaltrials.gov

Start Date

December 11, 2023

End Date

January 8, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Coopervision, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects will only be eligible for the study if:
•They were of legal age (18) and capacity to volunteer.
•They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent.
•They were willing and able to follow the protocol.
•They were wearing soft contact lenses, or had done so within the past two years.
•They were able to be fitted with the study lenses within the power range available.

Exclusion Criteria

•Subjects will not be eligible if:
•They had an ocular disorder which would normally contra-indicate contact lens wear.
•They had a systemic disorder which would normally contra-indicate contact lens wear.
•They were using any topical medication such as eye drops or ointment.
•They were aphakic.
•They had had corneal refractive surgery.
•They had any corneal distortion resulting from previous hard or rigid lens wear or had keratoconus.
•They were pregnant or lactating.
•They had an eye or health condition including an immunosuppressive or infectious disease which could, 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 had 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, unmanageable, cannot use lenses and 100=Excellent, highly impressed with these lenses overall