Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-13

Study Completion Date

2023-11-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess the clinical performance of DAILIES TOTAL1® spherical soft contact lenses over approximately 1 week of daily wear.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

DAILIES TOTAL1® Soft Contact Lenses - Post-Market Clinical Follow-up Study

NCT06483113

Myopia Hyperopia Presbyopia +1 more

TERMINATED

Initial Performance of a Modified Daily Disposable Contact Lens

NCT02694835

Refractive Error

COMPLETED NA

Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

NCT01634659

Myopia

COMPLETED NA

Pre-Lens Tear Film Performance of Silicone Hydrogel Daily Disposable Contact Lenses

NCT01548833

Myopia

COMPLETED NA

Clinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact Lens

NCT04702984

Refractive Errors

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Subjects will be expected to attend 2 visits (Visit 1 Screen/Baseline/ Dispense; and Visit 2 Week 1 Follow-up/ Exit). The total duration of a subject's participation in the study as well as exposure to the contact lenses will be approximately 1 week (6-8 days of contact lens wear).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Refractive Errors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

In this single arm study, the subject will be masked to the lens type.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DAILIES TOTAL1

Delefilcon A contact lenses worn in both eyes for the typical number of hours the subject wears his/her habitual contact lenses. The lenses will be worn in a daily disposable manner.

Group Type EXPERIMENTAL

Delefilcon A contact lenses

Intervention Type DEVICE

Daily disposable, silicone hydrogel spherical contact lenses

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Delefilcon A contact lenses

Daily disposable, silicone hydrogel spherical contact lenses

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DAILIES TOTAL1

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Current wearer of commercial spherical soft contact lenses in both eyes with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day;
* Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
* Best corrected distance visual acuity better than or equal to 20/25 (Snellen) in each eye.

Exclusion Criteria

* Current or prior habitual DAILIES TOTAL1 soft contact lens wear in the past 3 months prior to consent;
* Monovision contact lens wear;
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes