The Clinical Comparison of Somofilcon A 1 Day and Nelfilcon A Daily Disposable Contact Lenses

Launched by COOPERVISION, INC. · Aug 21, 2019

Keywords

ClinConnect Summary

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 soft contact lens with the nelfilcon A daily disposable lens when used on a daily wear, daily disposable basis.

Subjects will use each lens type for a week in random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 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.
• • 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.