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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014