Clincosm LogoSign in Get a demo

Complete Easy Rub Comparative Efficacy Study

Sponsor
Abbott Medical Optics (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01019564
Collaborator
(none)
0
Enrollment
2
Arms
3
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Complete Easy Rub Formula MPS
  • Device: Aquify MPS
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Study Start Date :
Dec 1, 2009
Anticipated Primary Completion Date :
Mar 1, 2010
Anticipated Study Completion Date :
Mar 1, 2010

Arms and Interventions

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

Outcome Measures

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. [Day 30]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Abbott Medical Optics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01019564
Other Study ID Numbers:
  • COMP-319-9424
First Posted:
Nov 25, 2009
Last Update Posted:
Jun 28, 2017
Last Verified:
Jun 1, 2017
Additional relevant MeSH terms:
Astigmatism
Hyperopia

Study Results

No Results Posted as of Jun 28, 2017