Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses

Conditions
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Myopia

Intervention / Treatment
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* Device: Methafilcon A IV
* Device: Ocufilcon B
* Device: Omafilcon A


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methafilcon A IV<br>Subjects are randomized to wear Methafilcon A IV for 1 hour during the cross over study. | Device: Ocufilcon B<br>* Contact Lens<br>Device: Omafilcon A<br>* Contact Lens<br>|
| Active Comparator: Ocufilcon B<br>Subjects are randomized to wear Ocufilcon B for 1 hour during the cross over study. | Device: Methafilcon A IV<br>* Contact Lens<br>Device: Omafilcon A<br>* Contact Lens<br>|
| Active Comparator: Omafilcon A<br>Subjects are randomized to wear Omafilcon A for 1 hour during the cross over study. | Device: Methafilcon A IV<br>* Contact Lens<br>Device: Ocufilcon B<br>* Contact Lens<br>|

What is the study measuring?
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Primary Outcome Measures

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