Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: Methafilcon A IV; Device: Omafilcon A; Device: Ocufilcon B

Study type: Interventional

Funder types: Industry

Identifiers

NCT03235115

EX-MKTG-85

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 3 patient groups

Methafilcon A IV

Active Comparator group

Description:

Subjects are randomized to wear Methafilcon A IV for 1 hour during the cross over study.

Treatment:

Device: Omafilcon A

Device: Ocufilcon B

Ocufilcon B

Active Comparator group

Description:

Subjects are randomized to wear Ocufilcon B for 1 hour during the cross over study.

Treatment:

Device: Omafilcon A

Device: Methafilcon A IV

Omafilcon A

Active Comparator group

Description:

Subjects are randomized to wear Omafilcon A for 1 hour during the cross over study.

Treatment:

Device: Ocufilcon B

Device: Methafilcon A IV