BlepharokeratoconjunctivitisPhase 4NCT00447577

Zylet vs TobraDex in Blepharokeratoconjunctivitis

A Phase 4 study testing Loteprednol etabonate and tobramycin ophthalmic suspension and Tobramycin and dexamethasone ophthalmic suspension in people with Blepharokeratoconjunctivitis, run by Bausch & Lomb Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Blepharokeratoconjunctivitis
What is being tested?: Loteprednol etabonate and tobramycin ophthalmic suspension and Tobramycin and dexamethasone ophthalmic suspension
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 276 participants
Where: 1 siteUnited States
Study dates: Jan 2007to Jun 2007
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

Cornerstone Eye Care
High Point, North Carolina, 27262

Other trials in United States

About this study

Official title: 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

Conditions: Blepharokeratoconjunctivitis
Being tested: Loteprednol etabonate and tobramycin ophthalmic suspension, Tobramycin and dexamethasone ophthalmic suspension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Loteprednol etabonate and tobramycin ophthalmic suspensionDrug
Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.
Tobramycin and dexamethasone ophthalmic suspensionDrug
Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.

Study groups in NCT00447577
Study group	Role	What they receive
Zylet	Experimental	Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3% (Zylet) Receives: Drug: Loteprednol etabonate and tobramycin ophthalmic suspension
Tobradex	Active comparator	Tobradex (tobramycin and dexamethasone ophthalmic suspension, 0.3%/0.1%), US marketed product (Alcon) from commercial lots. Receives: Drug: Tobramycin and dexamethasone ophthalmic suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

The primary efficacy endpoint for this study is the change from baseline to Day 15 in the signs and symptoms composite score
Measured: 15 days

Secondary outcomes (8)

The distribution of Investigator global assessment at each visit.
Measured: Visit 2, 3 & 4
The percentage of eyes that were considered improved or cured at each visit based on the Investigator global assessment.
Measured: 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.
Measured: Visit 2 & 3
The change from baseline to each visit in the signs composite score and the symptoms composite score.
Measured: 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.
Measured: Visit 1, 2, 3 & 4
The change from baseline to each visit in individual signs and symptoms.
Measured: Visit 1, 2, 3 & 4
VA, Biomicroscopy, and IOP assessments at each visit
Measured: Visit 1, 2, 3 & 4
Adverse Events
Measured: Visit 1, 2, 3 & 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Jun 2007

First posted14 Mar 2007 (estimated)
Study startJan 2007
Primary completionJun 2007
Study completionJun 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for BlepharokeratoconjunctivitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 276 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00447577
Sponsor's protocol ID: 512
Status last verified: Dec 2011
First submitted: 12 Mar 2007
Last updated: 9 Dec 2011
Results posted: No
Data monitoring committee: No

Publications

White EM, Macy JI, Bateman KM, Comstock TL. Comparison of the safety and efficacy of loteprednol 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of blepharokeratoconjunctivitis. Curr Med Res Opin. 2008 Jan;24(1):287-96. doi: 10.1185/030079908x253898.
PubMed 18062846

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00447577
Acronym / sponsor ID: 512
Conditions: Blepharokeratoconjunctivitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 276 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Jun 2007 (actual)
Study completion: Jun 2007 (actual)
First posted: 14 Mar 2007 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Zylet	Experimental	Drug: Loteprednol etabonate and tobramycin ophthalmic suspensionLoteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3% (Zylet)
Tobradex	Active comparator	Drug: Tobramycin and dexamethasone ophthalmic suspensionTobradex (tobramycin and dexamethasone ophthalmic suspension, 0.3%/0.1%), US marketed product (Alcon) from commercial lots.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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)

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Loteprednol etabonate and tobramycin ophthalmic suspensionSubjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.	Drug	Zylet
Tobramycin and dexamethasone ophthalmic suspensionSubjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.	Drug	Tobradex

Primary outcome

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

8 secondary outcomes

The distribution of Investigator global assessment at each visit.
Time frame: 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
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
The change from baseline to each visit in the signs composite score and the symptoms composite score.
Time frame: 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
The change from baseline to each visit in individual signs and symptoms.
Time frame: Visit 1, 2, 3 & 4
VA, Biomicroscopy, and IOP assessments at each visit
Time frame: Visit 1, 2, 3 & 4
Adverse Events
Time frame: Visit 1, 2, 3 & 4

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2011.
Derived from this study: PubMed 18062846White EM, Macy JI, Bateman KM, Comstock TL. Comparison of the safety and efficacy of loteprednol 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of blepharokeratoconjunctivitis. Curr Med Res Opin. 2008 Jan;24(1):287-96. doi: 10.1185/030079908x253898.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Timothy Comstock, OD study director

Bausch & Lomb Incorporated

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00447577, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2011.