Back to resultsComparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions
Primary Purpose
Myopia, Hyperopia, Astigmatism
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- were at least 18 years old;
- were experienced contact lens wearers;
- were correctable to at least 20/40 or better in both eyes with contact lenses;
- were in good general health, with healthy eyes (other than requiring vision correction);
- had not worn lenses for at least 12 hours before each baseline visit;
- had a corneal staining score no greater than Grade 1 in either eye at time of enrollment;
- had previously used an MPS or hydrogen peroxide solution successfully.
Exclusion Criteria:
- had a confirmed diagnosis of Sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition;
- required concurrent ocular medication or have used ocular medication within 24 hours of entering the study;
- had a known sensitivity or intolerance to any MPS, study products or ingredient(s);
- were currently participating in any other clinical study;
- had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.
Sites / Locations
- Abbott Medical Optics Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RevitaLens OcuTec Multipurpose Solution (Investigational MPS)
Opti-Free RepleniSH Multipurpose Solution (MPS, Control)
Arm Description
Outcomes
Primary Outcome Measures
Number of Eyes With No Change in Corneal Staining
Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe.
Secondary Outcome Measures
Full Information
NCT ID
NCT01024855
First Posted
December 2, 2009
Last Updated
September 30, 2015
Sponsor
Abbott Medical Optics
1. Study Identification
Unique Protocol Identification Number
NCT01024855
Brief Title
Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Optics
4. Oversight
5. Study Description
Brief Summary
A new multi-purpose solution (MPS)was clinically evaluated against Opti-Free RepleniSH MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hyperopia, Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RevitaLens OcuTec Multipurpose Solution (Investigational MPS)
Arm Type
Experimental
Arm Title
Opti-Free RepleniSH Multipurpose Solution (MPS, Control)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)
Intervention Description
multi-purpose lens care solution
Primary Outcome Measure Information:
Title
Number of Eyes With No Change in Corneal Staining
Description
Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe.
Time Frame
Change from baseline after 1, 2, 4 and 6+ hours of wear
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
were at least 18 years old;
were experienced contact lens wearers;
were correctable to at least 20/40 or better in both eyes with contact lenses;
were in good general health, with healthy eyes (other than requiring vision correction);
had not worn lenses for at least 12 hours before each baseline visit;
had a corneal staining score no greater than Grade 1 in either eye at time of enrollment;
had previously used an MPS or hydrogen peroxide solution successfully.
Exclusion Criteria:
had a confirmed diagnosis of Sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition;
required concurrent ocular medication or have used ocular medication within 24 hours of entering the study;
had a known sensitivity or intolerance to any MPS, study products or ingredient(s);
were currently participating in any other clinical study;
had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.
Facility Information:
Facility Name
Abbott Medical Optics Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions
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