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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention Phase
Myopia
Hyperopia
Astigmatism
Device: Complete Easy Rub Formula MPS
Device: Aquify MPS
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)

Further study details as provided by Abbott Medical Optics:

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. [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: December 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Eugenia Kao, Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01019564     History of Changes
Other Study ID Numbers: COMP-319-9424
Study First Received: November 20, 2009
Last Updated: February 15, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Astigmatism
Hyperopia
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 15, 2014