Complete Easy Rub Comparative Efficacy Study
Primary Purpose
Myopia, Hyperopia, Astigmatism
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Complete Easy Rub Formula MPS
Aquify MPS
Sponsored by
About this trial
This is an interventional other trial for Myopia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Easy Rub MPS
Aquify MPS
Arm Description
Complete Easy Rub Formula MPS
Outcomes
Primary Outcome Measures
Evaluation of lens cleanliness of test and control solutions when used with soft lenses at the end of the manufacturer-recommended replacement interval.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01019564
Brief Title
Complete Easy Rub Comparative Efficacy Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Business decision
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
March 2010 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Optics
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hyperopia, Astigmatism
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Easy Rub MPS
Arm Type
Experimental
Arm Description
Complete Easy Rub Formula MPS
Arm Title
Aquify MPS
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Complete Easy Rub Formula MPS
Intervention Description
Multi-purpose solution
Intervention Type
Device
Intervention Name(s)
Aquify MPS
Intervention Description
Multi-purpose solution
Primary Outcome Measure Information:
Title
Evaluation of lens cleanliness of test and control solutions when used with soft lenses at the end of the manufacturer-recommended replacement interval.
Time Frame
Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Complete Easy Rub Comparative Efficacy Study
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