N/A
Completed N=204
A Study to Determine the Prevalence of Inflammatory Dry Eye Disease in Patients Prior to Cataract Removal
Dry Eye Syndromes
Source: ClinicalTrials.gov NCT01882413 ↗
Enrolled (actual)
204
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcomePrimary: Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye — 36.2 percentage of participants
Summary
This study will evaluate the prevalence of inflammatory dry eye disease in patients prior to cataract surgery. No treatment is administered in this study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye |
36.2 | — |
| SECONDARY Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9 |
23.1 | — |
| SECONDARY Percentage of Participants With Elevated MMP-9 Without Prior Diagnosis or Physician Recommended Intervention |
36.6 | — |
| SECONDARY Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Conjunctival or Corneal Staining |
12.5 | — |
| SECONDARY Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Any Signs |
33.3 | — |
| SECONDARY Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign Without Dry Eye Symptoms |
38.2 | — |
| SECONDARY Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign and Dry Eye Symptoms |
29.3 | — |
| SECONDARY Percentage of Participants With Elevated MMP-9 Who Routinely Use Artificial Tears |
34.7 | — |
| SECONDARY Percentage of Participants With Elevated MMP-9 With Punctal Plugs |
— | — |
| SECONDARY Percentage of Participants With Elevated MMP-9 With Corneal Staining Grade ≥ 1 and ≥ 2 |
37.1; 41.9 | — |
| SECONDARY Percentage of Participants With Elevated MMP-9 and an Ocular Surface Disease Index® (OSDI®) > 12, > 22 and ≥ 32 |
39.7; 46.1; 46.0 | — |
Eligibility Criteria
Inclusion Criteria
- Scheduled to undergo cataract removal surgery
Exclusion Criteria
- Current use of eye drops or oral medications for allergic conjunctivitis
- Serious ocular injury, intraocular surgery, or refractive surgery within 6 months in the study eye
- Use of a contact lens within 4 weeks
Data sourced from ClinicalTrials.gov (NCT01882413). 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.