Complete Easy Rub Comparative Efficacy Study
This study has been withdrawn prior to enrollment.
(Business decision)
Sponsor:
Abbott Medical Optics
Information provided by:
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01019564
First received: November 20, 2009
Last updated: February 15, 2012
Last verified: February 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 May 23, 2013