MedDataX Logo

Clinical Evaluation on Using Personal Face Masks With Spectacles Versus Contact Lenses

NCT ID: NCT04658797

Last Updated: 2021-10-20

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-04-30

Brief Summary

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

The aim of this study was to explore satisfaction with vision correction and ease of use of PFM (Personal Face Masks) in a group of spectacle wearers who were randomised to continue wearing spectacles or be fitted with daily disposable contact lenses.

Detailed Description

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

This was a two arm parallel-group, randomised study. Subjects wearing single vision spectacles were recruited to participate in the study. Subjects were randomised to either continue to use their spectacles or to be fitted with the study daily disposable (DD) contact lens.

Conditions

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

Myopia

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Single Vision Spectacle for Vision correction

Single Vision Spectacle

Group Type ACTIVE_COMPARATOR

Single Vision Spectacle for Vision Correction

Intervention Type DEVICE

Single Vision Spectacle

Personal Facemask

Intervention Type OTHER

Personal Facemask

somofilcon A Daily disposable contact lenses

Daily disposable contact lenses

Group Type EXPERIMENTAL

somofilcon A Daily Disposable Contact Lens

Intervention Type DEVICE

Daily Disposable Contact Lens

Personal Facemask

Intervention Type OTHER

Personal Facemask

Interventions

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

somofilcon A Daily Disposable Contact Lens

Daily Disposable Contact Lens

Intervention Type DEVICE

Single Vision Spectacle for Vision Correction

Single Vision Spectacle

Intervention Type DEVICE

Personal Facemask

Personal Facemask

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

1. They are aged between 18 and 40 years.
2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They are a 'neophyte' (i.e. someone who has not worn contact lenses previously, with the exception for the purposes of a trial fitting).
5. They have a contact lens spherical prescription between +8.00D and -10.00D (inclusive) based on the ocular refraction.
6. They have a cylindrical correction of -0.75DC or less in each eye based on the ocular refraction.
7. They own and habitually wear single vision spectacles.
8. They are willing to be fitted with contact lenses and understand they may be randomised to either group.
9. They are willing to wear the contact lenses (if relevant) or spectacles for at least 8 hours per day, 5 days per week.
10. They are able to wear the supplied surgical masks for the majority of time that they need to wear PFM and will wear the PFM for at least one hour a day for at least four days per week.
11. They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses (if relevant) or spectacles.
12. They agree to not participate in other clinical research while enrolled on this study.

Exclusion Criteria

1. They have an ocular disorder which would normally contra-indicate contact lens
2. wear.
3. They have a systemic disorder which would normally contra-indicate contact lens wear.
4. They are using any topical medication such as eye drops or ointment.
5. They have had cataract surgery.
6. They have had corneal refractive surgery.
7. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
8. They are pregnant or breastfeeding.
9. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
10. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
11. They require significant ocular/face personal protective equipment beyond a personal face mask.
12. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
13. They have spectacles which are not within ±0.50D of their refractive error.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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

Principal Investigators

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

Carole Maldonado-Codina

Role: PRINCIPAL_INVESTIGATOR

Eurolens Research

Locations

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

Eurolens Research

Manchester, , United Kingdom

Site Status

Countries

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

United Kingdom

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.

C20-688 (EX-MKTG-120)

Identifier Type: -

Identifier Source: org_study_id