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A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease

NCT01212471 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 840

Last updated 2020-09-04

Study results available
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Summary

A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.

Conditions

  • Dry Eye Syndrome

Interventions

DRUG

Bromfenac Ophthalmic Solution A

sterile ophthalmic solution

DRUG

Bromfenac Ophthalmic Solution B

sterile ophthalmic solution

DRUG

Placebo Comparator

sterile ophthalmic solution

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Tim McNamara, PharmD · ISTA Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-08-31
Completion
2011-12-31

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 NCT01212471 on ClinicalTrials.gov