Comparison of a New Abbott Medical Optics (AMO) Multi-Purpose Solution (MPS) to Existing Contact Lens Regimens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01294917
First received: February 10, 2011
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

Crossover clinical evaluation three contact lens care regimens used for one month with Acuvue Oasys lenses.


Condition Intervention
Normal Contact Lens Wearers.
Device: Multi-purpose disinfecting solution
Device: Clear Care
Device: Opti-Free RepleniSH

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Official Title: Comparison of a New AMO MPS to Existing Contact Lens Regimens

Resource links provided by NLM:


Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Corneal Staining [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Corneal staining will be assessed with sodium fluorescein dye on the ocular surface. The cornea is split into 5 sections, each section is evaluated by staining type, depth, and extent is graded on a 0 to 100 scale with higher scores indicating more staining. The possible total range for the total score per eye is 0 to 50,000 (100x100x100=10,000 per section) with values higher than 1200 being clinically relevant.


Secondary Outcome Measures:
  • Subjective Lens Wearing Comfort [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    This will be assessed by a questionnaire on patient-perceived lens comfort and any symptoms of discomfort on a 0 to 100 scale.

  • Dryness [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    This will be assessed by the tear break-up time on the lens surface, measured in seconds.


Enrollment: 40
Study Start Date: February 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational MPS
AMO Investigational MPS.
Device: Multi-purpose disinfecting solution
For the cleaning, rinsing, and storage of soft contact lenses.
Active Comparator: Clear Care
Peroxide-based lens care regimen.
Device: Clear Care
Peroxide-based regimen for cleaning and disinfecting soft contact lenses.
Active Comparator: Opti-Free RepleniSH
Multi-purpose disinfecting solution (Alcon).
Device: Opti-Free RepleniSH
Multi-purpose disinfecting solution for the cleaning, rinsing and storing of soft contact lenses.

Detailed Description:

This is a three-arm crossover clinical evaluation of 40 subjects who will use each of three contact lens care regimens for one month with Acuvue Oasys lenses. The subjects will be randomized on the order of solutions used: Investigational MPS, ClearCare, and Opti-Free RepleniSH MPS.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Is at least 17 years of age and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Has had an ocular examination in the last two years;
  • Is a current soft lens wearer using either two-week or monthly replacement lenses;
  • Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction (either spectacles or contact lenses);
  • Has normal binocular vision (no strabismus, no amblyopia);
  • Has clear corneas and no active ocular disease;
  • Has a distance contact lens prescription between +8.00 diopters (D) to -12.00 D and a successful fit with the study lenses;
  • Has astigmatism less than or equal to -1.00 D;
  • Agrees to wear the study lenses on a daily wear basis.

Exclusion Criteria:

  • Has any active ocular disease;
  • Has any clinically significant lid, conjunctival, or corneal abnormalities that may affect a study outcome variable;
  • Has undergone corneal refractive surgery;
  • Has a systemic condition that may affect a study outcome variable;
  • Is using any systemic or topical medications that may affect ocular health;
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  • Is pregnant or lactating;
  • Is participating in any other clinical or research study that may affect a study outcome variable;
  • Currently wears daily disposable lenses or extended wear lenses.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294917

Locations
Canada, Ontario
Centre for Contact Lens Research
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
Abbott Medical Optics
Investigators
Principal Investigator: Craig Woods, MOptom University of Waterloo
  More Information

No publications provided

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01294917     History of Changes
Other Study ID Numbers: COBR-305-9608
Study First Received: February 10, 2011
Results First Received: February 15, 2012
Last Updated: May 18, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014