Evaluation of an Investigational Multi-Purpose Solution (MPS)

December 6, 2013 updated by: Abbott Medical Optics

Evaluation of an Investigational MPS

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

270

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • Complete Family Vision Center
    • Hawaii
      • Waipahu, Hawaii, United States, 96797
        • Eye Care Associates of Hawaii
    • Missouri
      • Warrensburg, Missouri, United States, 64093
        • InSight Eyecare
    • Ohio
      • Athens, Ohio, United States, 45701
        • Drs. Quinn, Quinn & Associates
      • Beachwood, Ohio, United States, 44122
        • Western Reserve Vision Care
      • Columbus, Ohio, United States, 43202
        • Central Ohio Eyecare
    • Pennsylvania
      • Scranton, Pennsylvania, United States, 18503
        • Northeastern Eye Institute
    • Rhode Island
      • Warwick, Rhode Island, United States, 02888
        • West Bay Eye Associates
    • Wisconsin
      • West Allis, Wisconsin, United States, 53227
        • Ziegler Leffingwell Eyecare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational MPS
Investigational multipurpose disinfecting solution (study MPS)
Device: Investigational MPS
Multi-purpose solution
Other Names:
  • Cobra
Active Comparator: Predicate MPS
Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
Device: Opti-Free
Multi-purpose solution
Other Names:
  • RepleniSH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Optics

Investigators

  • Study Chair: Nicholas Tarantino, OD, Abbott Medical Optics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

July 27, 2009

First Submitted That Met QC Criteria

August 17, 2009

First Posted (Estimate)

August 18, 2009

Study Record Updates

Last Update Posted (Estimate)

January 7, 2014

Last Update Submitted That Met QC Criteria

December 6, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • COBR-105-9608

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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