Phase 4
Completed N=30
Safety and Efficacy of Punctal Plug Insertion in Patients With Dry Eye
Source: ClinicalTrials.gov NCT01684436 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye — 2.24; 4.69; 9.08; 29.81 picogram/milliliter/millimeter(pg/ml/mm)
Summary
This study will access changes in tear protein levels and symptoms of dry eye following insertion of a punctal plug.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye |
2.24; 4.69; 9.08; 29.81; 0.57; 0.63 | — |
| PRIMARY Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye |
3.12; 3.97; 7.34; 29.14; 0.55; 1.10 | — |
| SECONDARY Corneal Fluorescein Staining Score in the Study Eye |
0.57; 1.33; 0.67; 0.72; 0.91; 0.48 | — |
| SECONDARY Tear Film Break-up Time (TBUT) |
2.21; 2.42 | — |
| SECONDARY Schirmer's Test Score |
5.07; 6.28 | — |
| SECONDARY Dry Eye Questionnaire Irritation Score |
53.81; 36.22 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with moderate to severe dry eye
Exclusion Criteria
- Previous punctal plug insertion in the last 3 months or presence of plugs at the time of study
- Contact lens wear in the 7 days prior to study start or during the study
- LASIK procedure in the last year
- Cataract or other eye surgery in the last 3 months
- Corneal grafts
Data sourced from ClinicalTrials.gov (NCT01684436). 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.