Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions | NCT01024855 | Trialant
CompletedInterventionalPhase 1Phase 2Updated Oct 20, 2015
Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions
ClinicalTrials.gov ID
NCT01024855
Lead Sponsor
Abbott Medical OpticsINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1Phase 2
Enrollment
30Actual
Last Update Posted
Oct 20, 2015Estimated
Start Date
Apr 2009
Primary Completion Date
Jun 2009Actual
Completion Date
Jun 2009Actual
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.
Myopia
Hyperopia
Astigmatism
RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
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.