N/A
Completed N=47
Safety and Tolerability of Artificial Tears in Dry Eye Subjects
Source: ClinicalTrials.gov NCT00932477 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcomePrimary: Tolerability Questionnaire Mean Scores at 1 Week — 70.1; 70.7; 57.3; 65.1 Scores on a scale
Summary
The safety and tolerability of two new artificial tears will be compared to a currently-available artificial tear in subjects with dry eye. Each subject will receive all three products in a randomly assigned order. The subject will use one product at a time for a duration of one week before switching to the next assigned product.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerability Questionnaire Mean Scores at 1 Week |
70.1; 70.7; 57.3; 65.1; 65.9; 53.4 | — |
| SECONDARY Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week |
1; 0; 0; 0; 1; 2 | — |
| SECONDARY Best-Corrected Visual Acuity (BCVA) Status at 1 Week |
0; 0; 0; 46; 45; 46 | — |
| SECONDARY The Number of Ophthalmic Adverse Events at 1 Week |
0; 0; 2; 0; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Mild, moderate or severe symptoms of dry eye
Exclusion Criteria
- Uncontrolled systemic disease
- Contact lens wear
- Participation in another clinical study
Data sourced from ClinicalTrials.gov (NCT00932477). 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.