Status:
COMPLETED
Short-Term Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions
Lead Sponsor:
Abbott Medical Optics
Conditions:
Corneal Staining
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
An investigational multi-purpose solution (MPS)was clinically evaluated against Biotrue MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 31 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01240122
Start Date
August 31 2010
End Date
November 30 2010
Last Update
March 3 2025
Active Locations (1)
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1
Abbott Medical Optics Inc
Santa Ana, California, United States, 92705