CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Loteprednol/tobramycin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01456780
NCT01456780Phase 4Completed
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Relative Efficacy of Loteprednol (Lotemax®) vs. Loteprednol/Tobramycin (Zylet®) in Treatment of Chronic Ocular Surface Inflammation Associated With Meibomian Gland Dysfunction (MGD)/Posterior Blepharitis

Massachusetts Eye and Ear Infirmary·interventional·Posted Oct 21, 2011·Updated Aug 1, 2017

In Brief

A Phase 4 clinical trial evaluating Loteprednol/tobramycin, Loteprednol, and 1 other intervention for Meibomian Gland Dysfunction and Posterior Blepharitis. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeibomian Gland Dysfunction, Posterior Blepharitis
CountriesUnited States
CollaboratorsBausch & Lomb Incorporated

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 21, 2011
Enrollment StartAug 1, 2011
Primary CompletionMar 1, 2013
Study CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.7 years ago

Interventions

Loteprednol/tobramycindrug

Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks.

Loteprednoldrug

Eye drops, 1 drop twice a day for 4 weeks

B+L Advanced Eye Relief Lubricant Dropdrug

Bausch + Lomb (B+L) Advanced Eye Relief Lubricant Drop (Artificial Tears), 1 drop twice a day for 4 weeks.