Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis

February 27, 2012 updated by: Bausch & Lomb Incorporated

A Clinical Safety and Efficacy Evaluation of Zylet® Versus Tobradex in the Treatment of Blepharokeratoconjunctivitis

This study is to evaluate the safety and efficacy of loteprednol etabonate [LE] and tobramycin ophthalmic suspension versus tobramycin and dexamethasone ophthalmic suspension in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis (BKC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

357

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 556741
        • Bausch & Lomb Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must have a clinical diagnosis of BKC in at least one eye
  • Subjects must be willing to discontinue contact lens use for the duration of the study
  • Subjects who are able and willing to comply with all treatment and follow- up/study procedures.

Exclusion Criteria:

  • Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
  • Subjects who have any uncontrolled systemic disease or debilitating disease.
  • Subjects who have a known hypersensitivity to the study drugs or their components (including benzalkonium chloride) or contraindications to tobramycin or ocular corticosteroids.
  • Subjects who use any topical or systemic ophthalmic medications listed as disallowed in the study protocol, within the specified time frame prior to Visit 1.
  • Subjects who have a disease or conditions which the Investigator determines could interfere with the safety and efficacy evaluations of the study drug.
  • Subjects having ocular surgery (including laser surgery) in either eye within the past three months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Loteprednol and tobramycin
Loteprednol etabonate and tobramycin ophthalmic suspension
Drug: Loteprednol and tobramycin
Loteprednol etabonate and tobramycin ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.
Other Names:
  • Zylet
Active Comparator: Tobramycin and dexamethasone
Tobramycin and dexamethasone ophthalmic suspension
Drug: Tobramycin and dexamethasone
Tobramycin and dexamethasone ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.
Other Names:
  • Tobradex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population
Time Frame: Baseline, Day 15
The change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP).
Baseline, Day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population
Time Frame: Baseline, Day 15
The CFB to Day 15 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population
Baseline, Day 15
Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population
Time Frame: Baseline, Day 8
The CFB to Day 8 (Visit 3) in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score.
Baseline, Day 8
Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population
Time Frame: Baseline, Day 8
The CFB to Day 8 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population
Baseline, Day 8
Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population
Time Frame: Baseline, Day 3
The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. PP population.
Baseline, Day 3
Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population
Time Frame: Baseline, Day 3
The CFB to Day 3 in the signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. ITT population.
Baseline, Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Study Director: Esther Chu, Bausch & Lomb Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

December 8, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Estimate)

February 28, 2012

Last Update Submitted That Met QC Criteria

February 27, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 617

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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