Comparison of Two Daily Disposable Soft Contact Lenses

A Clinical Comparison of Two Daily Disposable Soft Contact Lenses

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

Study Overview

• Status: Completed
• Conditions: Astigmatism Bilateral
• Intervention / Treatment: Device: midafilcon A; Device: somofilcon A

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Pleasanton, California, United States, 94588
      • CooperVision Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: midafilcon A; Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.	Device: midafilcon A; midafilcon A 1 day daily disposable contact lens
Active Comparator: somofilcon A; Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.	Device: somofilcon A; somofilcon A 1 day daily disposable contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Fit - Horizontal Centration	Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)	Baseline
Lens Fit - Horizontal Centration	Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)	One Week
Lens Fit - Vertical Centration	Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)	Baseline
Lens Fit - Vertical Centration	Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)	One Week
Lens Fit - Corneal Coverage	Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)	Baseline
Lens Fit - Corneal Coverage	Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)	One Week
Lens Fit - Lens Movement	Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)	Baseline
Lens Fit - Lens Movement	Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)	One Week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Score for Vision	Subjects will score on visual analogue scale for vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)	Baseline
Subjective Score for Vision	Subjects will score on visual analogue scale for Vision (0 -100) (0 - Unacceptable, 20 - Very poor, 40 - Poor, 60 - Good, 80 - Very Good, 100 - Excellent)	One week

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: Philip Morgan, PhD MCOptom FAAO FBCLA, Eurolens Research

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2019
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): September 18, 2019

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: EX-MKTG-99 (C18-649)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes