Complete Easy Rub Comparative Efficacy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01019564
Recruitment Status : Withdrawn (Business decision)
First Posted : November 25, 2009
Last Update Posted : June 28, 2017
Information provided by (Responsible Party):
Abbott Medical Optics

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.

Condition or disease Intervention/treatment Phase
Myopia Hyperopia Astigmatism Device: Complete Easy Rub Formula MPS Device: Aquify MPS Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Study Start Date : December 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2010

Arm Intervention/treatment
Experimental: Easy Rub MPS
Complete Easy Rub Formula MPS
Device: Complete Easy Rub Formula MPS
Multi-purpose solution

Active Comparator: Aquify MPS Device: Aquify MPS
Multi-purpose solution

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Responsible Party: Abbott Medical Optics Identifier: NCT01019564     History of Changes
Other Study ID Numbers: COMP-319-9424
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases