A Clinical Study of the Comfilcon A Asphere Soft Contact Lens in Users of Digital Devices

NCT ID: NCT04067050

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-04
• Study Completion Date: 2020-03-30

Brief Summary

The aim of this work is to investigate the clinical performance and subjective acceptance of the comfilcon A asphere contact lens when compared to single-vision spectacles in subjects who have never worn contact lenses and who use digital devices (such as phones, tablets, laptops, desktop computers) for at least 4 hours per day on at least 5 days per week.

Detailed Description

The aim of this clinical work is to compare the clinical performance and subjective acceptance of comfilcon A asphere contact lens when compared to single-vision spectacles in subjects who use digital devices (phones, tablets, laptops, desktop computers) for at least 4 hours per day on at least 5 days per week. Subjects will be randomized to use either their habitual spectacles or the study contact lenses for two months.

Conditions

Ametropia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

comfilcon A asphere

Subjects will wear their comfilcon A asphere contact lenses for two months. Lenses will be worn on a daily wear, reusable basis for at least 8 hours per day, 5 days per week.

Group Type: EXPERIMENTAL

comfilcon A asphere

Intervention Type: DEVICE

Contact Lens

Habitual Spectacles

Subjects will wear their single vision habitual spectacles for two months for at least 8 hours per day, 5 days per week.

Group Type: ACTIVE_COMPARATOR

Spectacles

Intervention Type: DEVICE

Habitual spectacles

Interventions

comfilcon A asphere

Contact Lens

Intervention Type: DEVICE

Spectacles

Habitual spectacles

Intervention Type: DEVICE

Other Intervention Names

test; Control; Single Vision Spectacles

Eligibility Criteria

Inclusion Criteria

• They are between 18 and 35 years of age (inclusive).
• They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
• They are willing and able to follow the protocol.
• They are a 'neophyte' (i.e. someone who has not worn contact lenses previously, with the exception for the purposes of a trial fitting, lasting up to one week).
• They have a contact lens spherical prescription between -1.00 to -6.25D (inclusive) based on the ocular refraction.
• They have a cylindrical correction of -0.875DC or less in each eye based on the ocular refraction
• They own and habitually wear single vision spectacles used for both distance and near vision, including computer and digital device use.
• Their single vision spectacles have a mean sphere equivalent within ±0.50D of that of the refraction found in the study for each eye (after having taken lens effectivity into account).
• They are willing to be fitted with contact lenses and understand they may be randomized to either group.
• They are willing to wear the contact lenses (if relevant) or spectacles for at least 8 hours per day, 5 days per week.
• They typically use digital devices for a minimum of 4 hours per day, 5 days per week.
• They agree not to change the spectacles they will wear for digital device use for the duration of the study.
• They agree not to participate in other clinical research for the duration of the study.

Exclusion Criteria

• They have an ocular disorder which would normally contra-indicate contact lens wear.
• They have a systemic disorder which would normally contra-indicate contact lens wear.
• They are using any topical medication such as eye drops (including comfort drops) or ointment on a regular basis.
• The spectacles they use for digital device viewing on the study have been made with specialist features for computer use, digital eye fatigue or are multifocal/bifocal.
• They are aphakic.
• They have had corneal refractive surgery.
• They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
• They are pregnant or breastfeeding.
• 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.
• They have evidence of a heterotropia or decompensating heterotropia on cover test.
• They have a history of having been prescribed prism in their spectacles (by self report).
• They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eurolens Research - The University of Manchester

Manchester, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EX-MKTG-105

Identifier Type: -

Identifier Source: org_study_id