Status:
COMPLETED
The Clinical Comparison of Somofilcon A 1 Day and Nelfilcon A Daily Disposable Contact Lenses
Lead Sponsor:
CooperVision, Inc.
Conditions:
Ametropia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This subject-masked, randomized, bilateral crossover study will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily dispos...
Detailed Description
This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross-comparison. This will compare the clinical performance and subjective acceptance of the somofilcon A 1 day so...
Eligibility Criteria
Inclusion
- They are of legal age (18) and capacity to volunteer.
- 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 agree not to participate in other clinical research for the duration of this study.
- They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)
- They have a maximum of -1.00DC ocular astigmatism in each eye.
- They can be satisfactorily fitted with the study lens types.
- 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 currently use soft contact lenses or have done so in the previous six months.
- They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
- They own a wearable pair of spectacles.
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.
- They have had cataract surgery.
- 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 breast-feeding.
- 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 other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
- They currently wear either the clariti 1day or the DAILIES AquaComfort Plus lens.
Key Trial Info
Start Date :
July 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04067141
Start Date
July 4 2019
End Date
November 20 2019
Last Update
November 24 2020
Active Locations (1)
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1
Eurolens Research
Manchester, United Kingdom, M13 9PL