Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens

NCT ID: NCT04464044

Last Updated: 2020-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-20

Study Completion Date

2020-08-06

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 obtain on-eye clinical performance data to evaluate the stability of axis orientation of DDT2 toric contact lenses in the intended population.

Detailed Description

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

This is a single-visit, non-dispense study where subjects will be exposed to the test lenses for approximately 1 hour.

Conditions

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

Astigmatism

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

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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

DDT2 Toric

Verofilcon A toric contact lenses worn in both eyes

Group Type EXPERIMENTAL

verofilcon A toric contact lenses

Intervention Type DEVICE

Daily disposable toric soft contact lenses

Interventions

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

verofilcon A toric contact lenses

Daily disposable toric soft 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.

DDT2 Toric

Eligibility Criteria

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

Inclusion Criteria

* Able to understand and sign an informed consent form;
* Successful wear of spherical or toric soft contact lenses in both eyes, as specified in the protocol;
* Willing to NOT use rewetting/lubricating drops at any time during the study;

Exclusion Criteria

* Any eye condition that would contraindicate contact lens wear, as determined by the Investigator;
* History of eye surgery within the previous 12 months, as specified in the protocol;
* Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trial Lead, Vision Care

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLA306-C003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.