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NCT01456780 · ClinicalTrials.gov registry record · Phase 4
Efficacy of Zylet vs. Lotemax for the Treatment of Ocular Surface Inflammation/MGD/Blepharitis
A Phase 4 study, sponsored by Massachusetts Eye and Ear Infirmary.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT01456780: Completed Phase 4 study, sponsored by Massachusetts Eye and Ear Infirmary.
NCT01456780 is a Phase 4 study that has completed, run by Massachusetts Eye and Ear Infirmary. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01456780, a Phase 4 study, has completed, sponsored by Massachusetts Eye and Ear Infirmary.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
This is a Phase IV, single site, randomized, double masked, parallel control clinical trial of 60 subjects to investigate the variance of efficacy between Lotemax® and Zylet® for treatment of ocular surface inflammation due to meibomian gland dysfunction (MGD). Efficacy will be measured by in-vivo confocal microscopy, corneal fluorescein staining, grading of meibomian gland dysfunction and validated ocular symptom assessment questionnaire.
Primary Outcome
OSDI is a 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0
Interventions
- DRUG Loteprednol/tobramycin
- DRUG Loteprednol
- DRUG B+L Advanced Eye Relief Lubricant Drop
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-08 |
| Est. Completion | 2017-06 |
| Phase | Phase 4 |
What the finished NCT01456780 record still lists
NCT01456780 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Loteprednol/tobramycin is the first listed.
NCT01456780 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01456780 about?
NCT01456780 is a clinical study titled "Efficacy of Zylet vs. Lotemax for the Treatment of Ocular Surface Inflammation/MGD/Blepharitis". This is a Phase IV, single site, randomized, double masked, parallel control clinical trial of 60 subjects to investigate the variance of efficacy between Lotemax® and Zylet® for treatment of ocular surface inflammation due to meibomian gland dysfunction (MGD). Efficacy will be measured by in-vivo c...
What is the current status of trial NCT01456780?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2011-08. Estimated completion is 2017-06.
What interventions are being tested in trial NCT01456780?
The interventions under investigation include: Loteprednol/tobramycin (DRUG), Loteprednol (DRUG), B+L Advanced Eye Relief Lubricant Drop (DRUG).
Who is sponsoring clinical trial NCT01456780?
This trial is sponsored by Massachusetts Eye and Ear Infirmary, which has 73 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01456780's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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