Clinical Comparison of Two Daily Disposable Soft Contact Lenses

Alcon Research1 site in 1 country22 target enrollmentMay 23, 2018

ConditionsMyopia Refractive Errors

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Alcon Research
Enrollment: 22
Locations: 1
Primary Endpoint: Overall Quality of Vision
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the overall performance of investigational contact lenses (DD T2) when compared to clariti® 1 day contact lenses.

Registry

clinicaltrials.gov

Start Date

May 23, 2018

End Date

June 11, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Alcon Research

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Understand and sign an Informed Consent Form;
•Successful wear of daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
•Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
•Willing to stop wearing habitual contact lenses for the duration of study participation;
•Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

•Anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator;
•Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
•Refractive, ocular, or intraocular surgery, as specified in the protocol;
•Eye condition or injury, as specified in the protocol;
•Current or history of intolerance, hypersensitivity, or allergy to any component of the study products;
•Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
•Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;
•Currently wearing clariti® 1 day contact lenses;
•Habitually wearing monovision or multifocal lenses during the last 3 months;
•Other protocol-specified exclusion criteria may apply.

Outcomes

Primary Outcomes

Overall Quality of Vision

Time Frame: Day 8, each product

Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated.