Zylet vs TobraDex in Blepharokeratoconjunctivitis

December 7, 2011 updated by: Bausch & Lomb Incorporated

A Clinical Safety and Efficacy Evaluation of Zylet (Loteprednol Etabonate and Tobramycin Ophthalmic Suspension) vs. Tobradex (Tobramycin and Dexamethasone Ophthalmic Suspension) in the Treatment of Blepharokeratoconjunctivitis

The objective of this study is to evaluate the safety and efficacy of Zylet vs. Tobradex in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
276

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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

  • United States
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Cornerstone Eye Care

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be at least 18 years of age
  • Must be able and willing to comply with all treatment and follow up procedures
  • Must have the ability to understand and sign an Informed Consent Form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization
  • Must be able to self-administer drugs
  • Must have a clinical diagnosis of blepharokeratoconjunctivitis in at least one eye (total Ocular Signs and Symptoms score of at least 10, with at least one ocular sign and one ocular symptom each having a score of Grade 2 level or higher)
  • Women of childbearing potential must be sexually inactive or using an approved birth control methods and must have a negative urine pregnancy test
  • Must be willing to discontinue contact lens use for the duration of the study
  • Must have pin-holed Snellen visual acuity equal to or better than 20/40 in both eyes

Exclusion Criteria:

  • Any uncontrolled systemic disease or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis)
  • Known hypersensitivity to the study drugs or their components (including benzalkonium chloride) or contraindications to tobramycin or ocular corticosteroids
  • Use of any systemic or topical ophthalmic non-steroidal anti-inflammatory agents, analgesics, and antihistamines that cannot be discontinued during the study
  • Use of any topical ophthalmic medications, including tear substitutes, within 2 hours before and that cannot be discontinued during the study
  • Use of any systemic or topical ophthalmic antibiotic agents within 72 hours before and that cannot be discontinued during the study
  • Use of any systemic or topical ophthalmic corticosteroid agents within 7 days before and that cannot be discontinued during the study
  • Use of any systemic or topical ophthalmic mast cell stabilizers within 14 days before and that cannot be discontinued during the study
  • Use of any topical ophthalmic immunosuppressant (e.g. Restasis) agents within 30 days before and that cannot be discontinued during the study
  • Suspected preseptal cellulites, or any other disease conditions which the Investigator determines could interfere with the safety and efficacy evaluations of the study drug
  • Suspected dacrocystitis
  • Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this study
  • Ocular surgery (including laser surgery) in either eye within the past 3 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Zylet
Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3% (Zylet)
Drug: Loteprednol etabonate and tobramycin ophthalmic suspension
Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.
Active Comparator: Tobradex
Tobradex (tobramycin and dexamethasone ophthalmic suspension, 0.3%/0.1%), US marketed product (Alcon) from commercial lots.
Drug: Tobramycin and dexamethasone ophthalmic suspension
Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The primary efficacy endpoint for this study is the change from baseline to Day 15 in the signs and symptoms composite score
Time Frame: 15 days
15 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The distribution of Investigator global assessment at each visit.
Time Frame: Visit 2, 3 & 4
Visit 2, 3 & 4
The percentage of eyes that were considered improved or cured at each visit based on the Investigator global assessment.
Time Frame: Visit 2, 3 & 4
Visit 2, 3 & 4
The change from baseline to Day 7 (Visit 3) and to Day 3 (Visit 2) in the signs and symptoms composite score.
Time Frame: Visit 2 & 3
Visit 2 & 3
The change from baseline to each visit in the signs composite score and the symptoms composite score.
Time Frame: Visit 1, 2, 3 & 4
Visit 1, 2, 3 & 4
The change from baseline to each visit in the Blepharitis signs composite score, the conjunctivitis signs composite score, and the Keratitis signs composite score.
Time Frame: Visit 1, 2, 3 & 4
Visit 1, 2, 3 & 4
The change from baseline to each visit in individual signs and symptoms.
Time Frame: Visit 1, 2, 3 & 4
Visit 1, 2, 3 & 4
VA, Biomicroscopy, and IOP assessments at each visit
Time Frame: Visit 1, 2, 3 & 4
Visit 1, 2, 3 & 4
Adverse Events
Time Frame: Visit 1, 2, 3 & 4
Visit 1, 2, 3 & 4

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 512

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings