A Clinical Comparison of Two Daily Disposable Soft Contact Lenses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coopervision, Inc.
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Lens Fit - Corneal Coverage
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •They are between 18 and 40 years of age (inclusive).
- •They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- •They are willing and able to follow the protocol.
- •They are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes.
- •They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive) based on ocular refraction.
- •They own a wearable pair of spectacles and wear them on the day of the initial visit.
- •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.
- •They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
- •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 or ointment, or use any rewetting/lubricating drops whilst on this study.
- •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 ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear
- •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 taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
Arms & Interventions
midafilcon A
Subjects will be randomized to wear midafilcon A 1 day for one week of daily wear during the study.
Intervention: midafilcon A (Device)
somofilcon A
Subjects will be randomized to wear somofilcon A 1 day for one week of daily wear during the study.
Intervention: somofilcon A (Device)
Outcomes
Primary Outcomes
Lens Fit - Corneal Coverage
Time Frame: One Week
Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Lens Fit - Lens Movement
Time Frame: One Week
Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Lens Fit - Horizontal Centration
Time Frame: One Week
Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
Lens Fit - Vertical Centration
Time Frame: One Week
Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
Lens Fit - Horizontal Centration
Time Frame: Baseline
Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
Lens Fit - Vertical Centration
Time Frame: Baseline
Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
Lens Fit - Corneal Coverage
Time Frame: Baseline
Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Lens Fit - Lens Movement
Time Frame: Baseline
Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Secondary Outcomes
- Subjective Score for Vision(One week)
- Subjective Score for Vision(Baseline)