N/A
Completed N=316
Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye
Source: ClinicalTrials.gov NCT00514852 ↗Enrolled (actual)
316
Serious AEs
0.6%
Results posted
Dec 2009
Primary outcomePrimary: Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score — 44; 45.2; -12.6; -13.6 Units on a scale
Summary
The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score |
44; 45.2; -12.6; -13.6; -16.3; -16.6 | — |
| SECONDARY Change From Baseline at Day 30 in Schirmer Test, With Anesthesia |
9.2; 8.6; 1.2; 1.2; 1.7; 1.8 | — |
| SECONDARY Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein |
4.3; 4.3; 0.9; 0.9; 1.1; 0.9 | — |
| SECONDARY Patient Acceptability Score (Dryness) at Day 30 |
47.4; 44.6; 60.7; 57.7; 63.3; 63.8 | — |
| SECONDARY Patient Acceptability Score (Vision) at Day 30 |
56.8; 54.2; 65.3; 62.6; 65.4; 66.4 | — |
| SECONDARY Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein |
4.0; 4.4; -1.2; -0.9; -1.3; -1.5 | — |
| SECONDARY Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein |
4.9; 5.1; -1.1; -1.0; -1.7; -1.5 | — |
| SECONDARY Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score |
2.8; 2.8; -0.5; -0.5; -0.7; -0.7 | — |
Eligibility Criteria
Inclusion Criteria
- Mild, moderate or Severe Symptoms of Dry Eye
Exclusion Criteria
- Uncontrolled systemic disease
- Use of systemic medications affecting dry eye
- Pregnancy or planning a pregnancy
- Contact lens wear
Data sourced from ClinicalTrials.gov (NCT00514852). 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.