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

Primary Purpose

Conjunctivitis, Keratitis, Blepharitis

Status
Completed
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
Loteprednol and tobramycin
Tobramycin and dexamethasone
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Conjunctivitis focused on measuring Blepharokeratoconjunctivitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bausch & Lomb Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Loteprednol and tobramycin

Tobramycin and dexamethasone

Arm Description

Loteprednol etabonate and tobramycin ophthalmic suspension

Tobramycin and dexamethasone ophthalmic suspension

Outcomes

Primary Outcome Measures

Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population
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).

Secondary Outcome Measures

Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population
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
Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population
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.
Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population
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
Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population
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.
Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population
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.

Full Information

First Posted
December 8, 2009
Last Updated
February 27, 2012
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01028027
Brief Title
Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis
Official Title
A Clinical Safety and Efficacy Evaluation of Zylet® Versus Tobradex in the Treatment of Blepharokeratoconjunctivitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conjunctivitis, Keratitis, Blepharitis
Keywords
Blepharokeratoconjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
357 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Loteprednol and tobramycin
Arm Type
Experimental
Arm Description
Loteprednol etabonate and tobramycin ophthalmic suspension
Arm Title
Tobramycin and dexamethasone
Arm Type
Active Comparator
Arm Description
Tobramycin and dexamethasone ophthalmic suspension
Intervention Type
Drug
Intervention Name(s)
Loteprednol and tobramycin
Other Intervention Name(s)
Zylet
Intervention Description
Loteprednol etabonate and tobramycin ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.
Intervention Type
Drug
Intervention Name(s)
Tobramycin and dexamethasone
Other Intervention Name(s)
Tobradex
Intervention Description
Tobramycin and dexamethasone ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.
Primary Outcome Measure Information:
Title
Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population
Description
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).
Time Frame
Baseline, Day 15
Secondary Outcome Measure Information:
Title
Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population
Description
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
Time Frame
Baseline, Day 15
Title
Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population
Description
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.
Time Frame
Baseline, Day 8
Title
Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population
Description
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
Time Frame
Baseline, Day 8
Title
Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population
Description
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.
Time Frame
Baseline, Day 3
Title
Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population
Description
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.
Time Frame
Baseline, Day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Chu
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb Inc
City
Singapore
ZIP/Postal Code
556741
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
22256909
Citation
Chen M, Gong L, Sun X, Gu Y, He X, Qu J, Wang L, Zhang M, Zhong X. A multicenter, randomized, parallel-group, clinical trial comparing the safety and efficacy of loteprednol etabonate 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of Chinese patients with blepharokeratoconjunctivitis. Curr Med Res Opin. 2012 Mar;28(3):385-94. doi: 10.1185/03007995.2012.659723. Epub 2012 Feb 7.
Results Reference
derived

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

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