a clinical study of the comfilcon a asphere soft contact lens in users of digital devices

Conditions: Ametropia

Summary: the aim of this work is to investigate the clinical performance and subjective acceptance of the comfilcon a asphere contact lens when compared to single-vision spectacles in subjects who have never worn contact lenses and who use digital devices (such as phones, tablets, laptops, desktop computers) for at least 4 hours per day on at least 5 days per week.

the aim of this clinical work is to compare the clinical performance and subjective acceptance of comfilcon a asphere contact lens when compared to single-vision spectacles in subjects who use digital devices (phones, tablets, laptops, desktop computers) for at least 4 hours per day on at least 5 days per week. subjects will be randomized to use either their habitual spectacles or the study contact lenses for two months.

Eligibility criteria:
inclusion criteria: * they are between 18 and 35 years of age (inclusive). * 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 are a 'neophyte' (i.e. someone who has not worn contact lenses previously, with the exception for the purposes of a trial fitting, lasting up to one week). * they have a contact lens spherical prescription between -1.00 to -6.25d (inclusive) based on the ocular refraction. * they have a cylindrical correction of -0.875dc or less in each eye based on the ocular refraction * they own and habitually wear single vision spectacles used for both distance and near vision, including computer and digital device use. * their single vision spectacles have a mean sphere equivalent within ±0.50d of that of the refraction found in the study for each eye (after having taken lens effectivity into account). * they are willing to be fitted with contact lenses and understand they may be randomized to either group. * they are willing to wear the contact lenses (if relevant) or spectacles for at least 8 hours per day, 5 days per week. * they typically use digital devices for a minimum of 4 hours per day, 5 days per week. * they agree not to change the spectacles they will wear for digital device use for the duration of the study. * 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 (including comfort drops) or ointment on a regular basis. * the spectacles they use for digital device viewing on the study have been made with specialist features for computer use, digital eye fatigue or are multifocal/bifocal. * 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 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 evidence of a heterotropia or decompensating heterotropia on cover test. * they have a history of having been prescribed prism in their spectacles (by self report). * they have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.