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Efficacy of Zylet vs. Lotemax for the Treatment of Ocular Surface Inflammation/MGD/Blepharitis

NCT01456780 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-08-01

Study results available
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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.

Conditions

  • Meibomian Gland Dysfunction
  • Posterior Blepharitis

Interventions

DRUG

Loteprednol/tobramycin

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

DRUG

Loteprednol

Eye drops, 1 drop twice a day for 4 weeks

DRUG

B+L Advanced Eye Relief Lubricant Drop

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

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    collaborator INDUSTRY

  • Massachusetts Eye and Ear Infirmary

    lead OTHER

Principal Investigators

  • Reza Dana, MD, MPH, MSc · Massachusetts Eye and Ear Infirmary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-03-31
Completion
2017-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01456780 on ClinicalTrials.gov