Comparison of Two Daily Disposable Soft Contact Lenses

NCT ID: NCT03779503

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-08
• Study Completion Date: 2019-09-18

Brief Summary

The aim of this study was to investigate the short-term clinical performance and subjective acceptance of the two study lenses.

Detailed Description

This study was a randomised, double-masked, crossover, bilateral dispensing study, controlled by cross-comparison. Fifty-five subjects will wear each lens brand for approximately one week in random order. Lenses were worn on a daily wear, daily disposable basis.

Conditions

Astigmatism Bilateral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

midafilcon A

Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.

Group Type: ACTIVE_COMPARATOR

midafilcon A

Intervention Type: DEVICE

midafilcon A 1 day daily disposable contact lens

somofilcon A

Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.

Group Type: ACTIVE_COMPARATOR

somofilcon A

Intervention Type: DEVICE

somofilcon A 1 day daily disposable contact lens

Interventions

midafilcon A

midafilcon A 1 day daily disposable contact lens

Intervention Type: DEVICE

somofilcon A

somofilcon A 1 day daily disposable contact lens

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. They are between 18 and 40 years of age (inclusive).

2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.

3. They are willing and able to follow the protocol.

4. They are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes.

5. They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive) based on ocular refraction.

6. They own a wearable pair of spectacles and wear them on the day of the initial visit.

7. At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.

8. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).

9. They agree not to participate in other clinical research for the duration of the study.

Exclusion Criteria

1. They have an ocular disorder, which would normally contra-indicate contact lens wear.

2. They have a systemic disorder, which would normally contra-indicate contact lens wear.

3. They are using any topical medication such as eye drops or ointment, or use any rewetting/lubricating drops whilst on this study.

4. They are aphakic.

5. They have had corneal refractive surgery.

6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

7. They are pregnant or breastfeeding.

8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear

9. 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.

10. They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Morgan, PhD MCOptom FAAO FBCLA

Role: PRINCIPAL_INVESTIGATOR

Eurolens Research

Locations

CooperVision Inc.

Pleasanton, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EX-MKTG-99 (C18-649)

Identifier Type: -

Identifier Source: org_study_id