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Complete Easy Rub Comparative Efficacy Study

This study has been withdrawn prior to enrollment.
(Business decision)
Sponsor:
Information provided by:
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01019564
First received: November 20, 2009
Last updated: February 15, 2012
Last verified: February 2012

November 20, 2009
February 15, 2012
December 2009
March 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01019564 on ClinicalTrials.gov Archive Site
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Complete Easy Rub Comparative Efficacy Study
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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.
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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
  • Myopia
  • Hyperopia
  • Astigmatism
  • Device: Complete Easy Rub Formula MPS
    Multi-purpose solution
  • Device: Aquify MPS
    Multi-purpose solution
  • Experimental: Easy Rub MPS
    Complete Easy Rub Formula MPS
    Intervention: Device: Complete Easy Rub Formula MPS
  • Active Comparator: Aquify MPS
    Intervention: Device: Aquify MPS
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT01019564
COMP-319-9424
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Eugenia Kao, Abbott Medical Optics
Abbott Medical Optics
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Abbott Medical Optics
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP