MedDataX Logo

Somofilcon A 1-Day Multifocal Study - Real World Subjective Acceptance Study

NCT ID: NCT03519919

Last Updated: 2019-12-19

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

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-21

Study Completion Date

2019-02-15

Brief Summary

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

The objective of the study is to evaluate the performance of somofilcon A 1 day multifocal when worn on a daily disposable wear modality over a period of up to 3 weeks.

Detailed Description

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

Conditions

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

Presbyopia

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

Study Groups

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

Somofilcon A multifocal lens

Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment.

Group Type EXPERIMENTAL

somofilcon A multifocal lens

Intervention Type DEVICE

contact lens

Interventions

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

somofilcon A multifocal lens

contact lens

Intervention Type DEVICE

Other Intervention Names

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

clarifi multifocal lens

Eligibility Criteria

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

Inclusion Criteria

* Is at least 17 years of age and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Has had a self-reported oculo-visual examination in the last two years.
* Currently wears multifocal soft contact lenses, and have worn multifocal contact lenses for at least one month;
* Presently wears lenses for minimum wear 4 days/week and 10 hours/day
* Participant has an anticipated ability to wear test lenses for minimum 5 days/week and 10 hours/day.
* Can be fit with the available test contact lens power range to achieve satisfactory vision i.e. 0.18 logMar (20/30) binocular distance acuity with the test lenses.
* Current refraction indicates a reading addition of +1.50 or higher
* Uses a digital device (computer/laptop/tablet etc.) for at least 5hrs/day
* Spends 10 hrs or more indoors at least 5 days/week
* Possesses a smartphone and is willing to download the MetricWire app to receive

Exclusion Criteria

* Is presently wearing Clariti 1 day multifocal lenses
* Has astigmatism greater than -0.75 DCyl as determined with subjective refraction
* Is participating in any concurrent clinical or research study;
* Has any known active\* ocular disease and/or infection;
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
* Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
* Has known sensitivity to fluorescein dye or products to be used in the study;
* Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
* Is aphakic;
* Has undergone refractive error surgery;
* Is an employee of the Centre for Contact Lens Research
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

CooperVision, Inc.

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

Locations

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

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, Canada

Site Status

Countries

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

Canada

Provided Documents

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

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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

EX-MKTG-81

Identifier Type: -

Identifier Source: org_study_id