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NCT02120079 · ClinicalTrials.gov registry record · Phase 4
The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED
A Phase 4 study, sponsored by Tufts Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 37
- Enrollment target
NCT02120079 is a Phase 4 study that has completed, run by Tufts Medical Center. The registered enrollment target is 37 participants.
The verdict
NCT02120079, a Phase 4 study, has completed, sponsored by Tufts Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 37 participants
- Enrollment target
Study Summary
This research study is looking to see if in vivo confocal microscopy (IVCM) imaging can be used to confirm clinical findings (which are noted by the doctor during an eye exam) and measure the immune response to the inflammation in the subject's cornea (the front part of the eyeball). Additionally, this study is trying to determine the effectiveness of two eye-drops, Lotemax and artificial tears, in treating the inflammation associated with DED by measuring changes in immune cells with IVCM imaging. The subject will be treated with either Lotemax (loteprednol) or artificial tears (a lubricating eye drop with no medication). Lotemax is an FDA-approved steroid eye-drop that is often used to treat inflammation associated with DED. Artificial tears are approved by the FDA for treatment of dryness associated with DED. Thus, this study is designed to determine the effects of the administration of a topical steroid, Lotemax, over a treatment period of 6 weeks, using novel methods of detecting efficacy. In order to achieve the aforementioned goal, subjects will be prospectively randomized to one of two treatment arms - Lotemax or artificial tear. Both groups will follow the same study schedule.
Interventions
- DRUG Lotemax
- DRUG Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
- DIAGNOSTIC_TEST In Vivo Confocal Microscopy (IVCM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2014-02 |
| Est. Completion | 2018-01-28 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02120079
The ClinicalTrials.gov registry entry for NCT02120079 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tufts Medical Center, which has 169 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Lotemax is the first listed.
NCT02120079 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02120079 about?
NCT02120079 is a clinical study titled "The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED". This research study is looking to see if in vivo confocal microscopy (IVCM) imaging can be used to confirm clinical findings (which are noted by the doctor during an eye exam) and measure the immune response to the inflammation in the subject's cornea (the front part of the eyeball). Additionally, ...
What is the current status of trial NCT02120079?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 37 participants. The study started on 2014-02. Estimated completion is 2018-01-28.
What interventions are being tested in trial NCT02120079?
The interventions under investigation include: Lotemax (DRUG), Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) (DRUG), In Vivo Confocal Microscopy (IVCM) (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT02120079?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
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