Complete Easy Rub Comparative Efficacy Study

Study Overview
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Brief Summary
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The aim of this trial is to assess Complete Easy Rub compared to a competitor multi-purpose solution in terms of lens cleanliness, subjective response and ocular response, when lenses are worn bilaterally on a daily wear basis for two months. The hypotheses for this trial are: Lens cleanliness measures between solutions will be no different. Subjective ratings between solutions will be no different. Ocular response between solutions will be no different.

Conditions
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Myopia, Hyperopia, Astigmatism

Intervention / Treatment
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* Device: Complete Easy Rub Formula MPS
* Device: Aquify MPS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent; Be at least 18 years old, male or female; Willing to comply with the wearing and clinical trial visit schedule as directed by the investigator; Have ocular health findings considered to be normal and which would not prevent the participant from safely wearing contact lenses; Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses; Able to successfully wear one of the lens types to be used in this study on a daily wear (DW) basis in conjunction with any multi-purpose contact lens care solution (not including hydrogen peroxide-based systems) for at least one month prior to allocation of test or control solution; Exclusion Criteria: Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses; Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants; Use of, or a need for, concurrent category S3 and above ocular medication at enrolment and/or during the study; Use of, or a need for, any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant's ocular health/physiology or contact lens performance either in an adverse manner or beneficial manner at enrolment and/or during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Easy Rub MPS<br>Complete Easy Rub Formula MPS | Device: Complete Easy Rub Formula MPS<br>* Multi-purpose solution<br>|
| Active Comparator: Aquify MPS<br> | Device: Aquify MPS<br>* Multi-purpose solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of lens cleanliness of test and control solutions when used with soft lenses at the end of the manufacturer-recommended replacement interval. |  | Day 30 |