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

CooperVision, Inc.70 enrolled

Overview

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 disposable lens when used on a daily wear, daily disposable basis.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Ametropia

Interventions

somofilcon ADEVICE

Contact Lens

nelfilcon ADEVICE

Contact Lens

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Eurolens Research

Manchester, United Kingdom

Outcomes

Primary Outcomes

Subjective Comfort at Lens Dispensing

Subjective comfort at lens dispensing on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).

Time frame: Baseline (after 5 minutes of lens dispense)

Subjective Comfort at Start of Day

Subjective comfort at start of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).

Time frame: 1 week

Subjective Comfort at End of Day

Subjective comfort at end of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).

Time frame: 1 week

Overall Subjective Comfort

Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).

Time frame: Baseline (after 5 minutes of lens dispense)

Overall Subjective Comfort

Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).

Time frame: 1 week

Subjective Vision

Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.)

Time frame: Baseline (after 5 minutes of lens dispense)

Subjective Vision

Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.)

Time frame: 1 week

Secondary Outcomes

Data from ClinicalTrials.gov

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