A Clinical Comparison of Two Soft Contact Lenses (C24-755)

CooperVision, Inc.1 site in 1 country52 target enrollmentNovember 18, 2024

ConditionsHyperopia Myopia

InterventionsLens 1 (ocufilcon D)Lens 2 (somofilcon A)

Overview

Phase: Not Applicable
Intervention: Lens 1 (ocufilcon D)
Conditions: Hyperopia
Sponsor: CooperVision, Inc.
Enrollment: 52
Locations: 1
Primary Endpoint: Subjective Overall Score
Status: Completed
Last Updated: 19 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to compare the short-term clinical performance of two soft contact lenses.

Detailed Description

The aim of this study is to evaluate the short-term clinical performance of two soft contact lenses when compared to each other after 15 minutes of daily wear each.

Registry

clinicaltrials.gov

Start Date

November 18, 2024

End Date

January 31, 2025

Last Updated

19 days 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 breastfeeding.
•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.

Arms & Interventions

Lens 1 (ocufilcon D)

All participants will wear lens 1 for 15 minutes (Period 1).

Intervention: Lens 1 (ocufilcon D)

Lens 2 (somofilcon A)

All participants will wear lens 2 for 15 minutes (Period 2).

Intervention: Lens 2 (somofilcon A)

Outcomes

Primary Outcomes

Subjective Overall Score

Time Frame: At the end of 15 minutes of daily wear

The primary outcome measure for this study is the subjective overall score on a scale of 0-100 (0= Extremely poor, unmanageable, cannot use lenses, 100= Excellent, highly impressed with these lenses overall).