Evaluation of an Investigational Multi-Purpose Solution (MPS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT00961051
First received: July 27, 2009
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to evaluate the safety and effectiveness of an investigational multi-purpose contact lens solution.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluation of an Investigational MPS

Resource links provided by NLM:


Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Mean Lens Cleanliness as Measured by Light Reflectance [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    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:
  • Number of Subjects With no Corneal Staining [ Time Frame: Day 180 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 270
Study Start Date: February 2009
Study Completion Date: November 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00961051

Locations
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
Study Chair: Nicholas Tarantino, OD Abbott Medical Optics
  More Information

No publications provided

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT00961051     History of Changes
Other Study ID Numbers: COBR-105-9608
Study First Received: July 27, 2009
Results First Received: May 16, 2013
Last Updated: December 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Abbott Medical Optics:
adapted contact lens wearers

ClinicalTrials.gov processed this record on April 17, 2014