Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses

Not Applicable

Completed

Brief Summary: This study aims to compare the short-term clinical performance of the three contact lenses (Methafilcon A IV, Ocufilcon B 1-day and Omafilcon A 1-day daily disposable).

Detailed Description: This will be a randomized, double-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. Forty subjects will wear each lens brand for approximately one hour, on three separate study days in random order. Lenses will only be worn during study visits.

Recruitment & Eligibility

Inclusion Criteria

They are of aged 18-40 and have 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 spectacle cylindrical correction of -0.75D or less in each eye (based on the ocular refraction).
They can attain at least 0.10 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.

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 lactating.
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.

Primary Outcome Measures

Name	Time	Method
Visual Acuity Using logMAR	Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn	Assessment of visual performance using the Bailey-Lovie logMAR visual acuity test chart and procedures for carrying out an over-refraction
Lens Fit - Horizontal Centration	Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn	Assessment of horizontal centration of lens on eye
Lens Fit - Vertical Centration	Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn	Assessment of vertical centration of lens on eye
Lens Fit - Corneal Coverage of Lens	Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn	Assessment of corneal coverage of lens on eye
Lens Fit - Movement of Lens	Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn	Assessment of movement of lens on eye

Secondary Outcome Measures

Name	Time	Method

Locations (1): Eurolens Research - The University of Manchester
🇬🇧
Manchester, United Kingdom
Eurolens Research - The University of Manchester
🇬🇧Manchester, United Kingdom