Phase 2
Completed N=30
Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions
Source: ClinicalTrials.gov NCT01024855 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcomePrimary: Number of Eyes With No Change in Corneal Staining — 16; 17; 19; 14 eyes
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Eyes With No Change in Corneal Staining |
16; 17; 19; 14; 21; 21 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01024855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.