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A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease

NCT01014078 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2011-09-26

No results posted yet for this study

Summary

The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% in dry eye subjects over a four week treatment period, using placebo as a comparison.

Conditions

Interventions

DRUG

Azithromycin Ophthalmic Solution, 1%

1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)

DRUG

Placebo

1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)

Sponsors & Collaborators

Principal Investigators

  • Reza Haque, MD, PhD · Medical Monitor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01014078 on ClinicalTrials.gov