Home
Clinical Trials
NCT04527978

Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1

NCT ID: NCT04527978

Last Updated: 2021-11-23

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2020-11-06

Brief Summary

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

The primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Biotrue ONEday contact lenses.

Detailed Description

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

Subjects are expected to attend 3 study visits and wear the PRECISION1 and Biotrue ONEday study lenses in a crossover design for approximately 8 days of exposure to each study lens type. The expected duration of subject participation is up to 22 days.

Conditions

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

Refractive Errors Myopia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Daily disposable contact lenses

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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

PRECISION1, then Biotrue ONEday

Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.

Group Type OTHER

Verofilcon A contact lenses

Intervention Type DEVICE

Spherical soft contact lenses for daily disposable wear

Nesofilcon A contact lenses

Intervention Type DEVICE

Spherical soft contact lenses for daily disposable wear

Biotrue ONEday, then PRECISION1

Nesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.

Group Type OTHER

Verofilcon A contact lenses

Intervention Type DEVICE

Spherical soft contact lenses for daily disposable wear

Nesofilcon A contact lenses

Intervention Type DEVICE

Spherical soft contact lenses for daily disposable wear

Interventions

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

Verofilcon A contact lenses

Spherical soft contact lenses for daily disposable wear

Intervention Type DEVICE

Nesofilcon A contact lenses

Spherical soft contact lenses for daily disposable wear

Intervention Type DEVICE

Other Intervention Names

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

PRECISION1™ Biotrue ONEday Bausch + Lomb Biotrue® ONEday

Eligibility Criteria

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

Inclusion Criteria

* Subject must be able to understand and must sign an Institution Review Board (IRB) approved Informed Consent Form.
* Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
* Willing to wear contact lenses for at least 16 hours per day on one of the days with each lens type.

Exclusion Criteria

* Any ocular condition that contraindicates contact lens wear.
* Previous or current habitual wearer of PRECISION1, Biotrue ONEday, or DAILIES TOTAL1 contact lenses.

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.

CDMA Project 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.

Alcon Investigator 6565

Maitland, Florida, United States

Site Status

Alcon Investigator 6402

Medina, Minnesota, United States

Site Status

Alcon Investigator 6313

Powell, Ohio, United States

Site Status

Alcon Investigator 8028

Wichita Falls, Texas, United States

Site Status

Countries

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

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

Document Type: Statistical Analysis Plan

Other Identifiers

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

CLE383-P003

Identifier Type: -

Identifier Source: org_study_id