Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of an Investigational Multi-Purpose Solution (MPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00961051
Recruitment Status : Completed
First Posted : August 18, 2009
Results First Posted : January 7, 2014
Last Update Posted : January 7, 2014
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of an investigational multi-purpose contact lens solution.

Condition or disease Intervention/treatment Phase
Study Focus is Healthy Contact Lens Wearers Device: Investigational MPS Device: Opti-Free Phase 3

Detailed Description:
A new multi-purpose solution has been developed for optimal lens disinfection and lens wearing comfort, compatible with a wide variety of commercially available lenses. Ten investigative sites were selected to evaluate 274 soft contact lens wearers in a parallel group study of one investigational multi-purpose solution and one marketed predicate solution.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluation of an Investigational MPS
Study Start Date : February 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : November 2009
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Investigational MPS
Investigational multipurpose disinfecting solution (study MPS)
 Device: Investigational MPS
Multi-purpose solution
Other Name: Cobra
Active Comparator: Predicate MPS
Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
 Device: Opti-Free
Multi-purpose solution
Other Name: RepleniSH


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Mean Lens Cleanliness as Measured by Light Reflectance [ Time Frame: Day 30 ]
    Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque).


Secondary Outcome Measures :
  1. Number of Subjects With no Corneal Staining [ Time Frame: Day 180 ]
    Corneal staining was performed via slit lamp observation of the corneal through a cobalt blue filter and a yellow #12 or #15 filter Wratten filter following contact lens removal and installation of standard sodium fluorescein.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have successfully worn hydrogel contact lenses of the same material to be worn during the study
  • Have normal eyes (with the exception of unaided visual acuity)
  • Have successfully used a multi-purpose contact lens care solution
  • Have acceptable visual acuity and lens wearing comfort at time of enrollment

Exclusion Criteria:

  • Concurrently enrolled another clinical trial
  • Have a known sensitivity to any study product ingredient(s)
  • Have a condition that may put them at significant risk
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00961051


Locations
Layout table for location information
United States, California
Complete Family Vision Center
San Diego, California, United States, 92123
United States, Hawaii
Eye Care Associates of Hawaii
Waipahu, Hawaii, United States, 96797
United States, Missouri
Insight Eyecare
Warrensburg, Missouri, United States, 64093
United States, Ohio
Drs. Quinn, Quinn & Associates
Athens, Ohio, United States, 45701
Western Reserve Vision Care
Beachwood, Ohio, United States, 44122
Central Ohio Eyecare
Columbus, Ohio, United States, 43202
United States, Pennsylvania
Northeastern Eye Institute
Scranton, Pennsylvania, United States, 18503
United States, Rhode Island
West Bay Eye Associates
Warwick, Rhode Island, United States, 02888
United States, Wisconsin
Ziegler Leffingwell Eyecare
West Allis, Wisconsin, United States, 53227
Sponsors and Collaborators
Abbott Medical Optics
Investigators
Layout table for investigator information
Study Chair: Nicholas Tarantino, OD Abbott Medical Optics
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT00961051    
Other Study ID Numbers: COBR-105-9608
First Posted: August 18, 2009    Key Record Dates
Results First Posted: January 7, 2014
Last Update Posted: January 7, 2014
Last Verified: December 2013
Keywords provided by Abbott Medical Optics:
adapted contact lens wearers