Status:
COMPLETED
Comparison of Two Daily Disposable Soft Contact Lenses
Lead Sponsor:
CooperVision, Inc.
Conditions:
Astigmatism Bilateral
Eligibility:
All Genders
18-40 years
Phase:
NA
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 or...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2019
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03779503
Start Date
February 8 2019
End Date
September 18 2019
Last Update
October 8 2020
Active Locations (1)
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1
CooperVision Inc.
Pleasanton, California, United States, 94588