ConjunctivitisPhase 4NCT00705159

Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis

A Phase 4 study testing loteprednol etabonate and tobramycin, loteprednol etabonate and Tobramycin in people with Conjunctivitis, 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 effectiveness of Zylet in comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of blepharoconjunctivitis in pediatric subjects. Read more about this study

Who is it for?: Ages 1 week to 6 years
Conditions the study is for: Conjunctivitis
What is being tested?: loteprednol etabonate and tobramycin, loteprednol etabonate and Tobramycin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 137 participants
Where: 1 siteUnited States
Study dates: Jun 2008to May 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 1 week to 6 years
All sexes
No healthy volunteers
Child

Who may be able to join

children 0-6 years of age.
clinical diagnosis of blepharoconjunctivitis
Parent/guardian must understand, be willing and able to comply with all treatment and follow-up procedures.
Parent/guardian must understand, be willing and able to provide informed consent and Health Insurance Portability Accountability Act (HIPAA) authorization.

Who cannot join

Known hypersensitivity to corticosteroids, aminoglycosides, or any component of the study medication.
Subjects who have a history of ocular surgery, including laser procedures, within the past 6 months.
Subjects who are monocular.
Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study.
Subjects who have participated in an ophthalmic drug or device research study within 30 days prior to entry in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pediatric Ophthalmology of Erie
Erie, Pennsylvania, 16501

Other trials in United States

About this study

Conditions: Conjunctivitis
Being tested: loteprednol etabonate and tobramycin, loteprednol etabonate, Tobramycin, Vehicle of Zylet
Keywords: Blepharokeratoconjunctivitis
Medical subject headings: Conjunctivitis

What participants receive

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

loteprednol etabonate and tobramycinDrug
Also called Zylet
Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.
loteprednol etabonateDrug
Also called Lotemax
Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.
TobramycinDrug
Topical ocular administration of Tobramycin QID for 14 days.
Vehicle of ZyletDrug
Topical ocular administration of the vehicle of Zylet QID for 14 days.

Study groups in NCT00705159
Study group	Role	What they receive
Loteprednol etabonate and tobramycin	Experimental	Drug: Zylet (loteprednol etabonate and tobramycin) Receives: Drug: loteprednol etabonate and tobramycin
Loteprednol etabonate	Active comparator	Drug: Lotemax (loteprednol etabonate) Receives: Drug: loteprednol etabonate
Tobramycin	Active comparator	Drug: Tobramycin Receives: Drug: Tobramycin
Vehicle	Placebo comparator	Vehicle of Zylet Receives: Drug: Vehicle of Zylet

What is being measured

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

Change From Baseline in the Total Blepharoconjunctivitis Grade.
Change from baseline to visit 4 in the total blepharoconjunctivitis grade. Graded on a scale of 0-4, 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.
Measured: Baseline to 15 days

Secondary outcomes (2)

Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2
Change from baseline in total blepharoconjunctivitis grade to visit 2(day 3) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.
Measured: Baseline to Day 3
Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3
Change from baseline in total blepharoconjunctivitis grade to visit 3(day 7) measured on a scale of 0-4. 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.
Measured: Baseline to Day 7

Timeline

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

Jun 2008May 2010

First posted25 Jun 2008 (estimated)
Study startJun 2008
Primary completionMar 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ConjunctivitisStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 137 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00705159
Sponsor's protocol ID: 550
Status last verified: Mar 2015
First submitted: 20 Jun 2008
Last updated: 24 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
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All Conjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis
ClinicalTrials.gov ID: NCT00705159
Acronym / sponsor ID: 550
Conditions: Conjunctivitis
Keywords: Blepharokeratoconjunctivitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 137 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Jun 2008
Primary completion: Mar 2010 (actual)
Study completion: May 2010 (actual)
First posted: 25 Jun 2008 (estimated)
Results: Posted 11 Aug 2011

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Loteprednol etabonate and tobramycin	Experimental	Drug: loteprednol etabonate and tobramycinDrug: Zylet (loteprednol etabonate and tobramycin)
Loteprednol etabonate	Active comparator	Drug: loteprednol etabonateDrug: Lotemax (loteprednol etabonate)
Tobramycin	Active comparator	Drug: TobramycinDrug: Tobramycin
Vehicle	Placebo comparator	Drug: Vehicle of ZyletVehicle of Zylet

Who may qualify

Ages: 1 week to 6 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

children 0-6 years of age.
clinical diagnosis of blepharoconjunctivitis
Parent/guardian must understand, be willing and able to comply with all treatment and follow-up procedures.
Parent/guardian must understand, be willing and able to provide informed consent and Health Insurance Portability Accountability Act (HIPAA) authorization.

Key exclusion criteria (5 listed)

Known hypersensitivity to corticosteroids, aminoglycosides, or any component of the study medication.
Subjects who have a history of ocular surgery, including laser procedures, within the past 6 months.
Subjects who are monocular.
Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study.
Subjects who have participated in an ophthalmic drug or device research study within 30 days prior to entry in this 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 tobramycinAlso: ZyletTopical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.	Drug	Loteprednol etabonate and tobramycin
loteprednol etabonateAlso: LotemaxTopical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.	Drug	Loteprednol etabonate
TobramycinTopical ocular administration of Tobramycin QID for 14 days.	Drug	Tobramycin
Vehicle of ZyletTopical ocular administration of the vehicle of Zylet QID for 14 days.	Drug	Vehicle

Primary outcome

Change From Baseline in the Total Blepharoconjunctivitis Grade.
Time frame: Baseline to 15 days
Change from baseline to visit 4 in the total blepharoconjunctivitis grade. Graded on a scale of 0-4, 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.

2 secondary outcomes

Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2
Time frame: Baseline to Day 3
Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3
Time frame: Baseline to Day 7

Results and safety

Results posted to the registry on 11 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Loteprednol Etabonate and Tobramycin	34	34
Loteprednol Etabonate	35	33
Tobramycin	34	29
Vehicle	34	30

Primary outcome: Change From Baseline in the Total Blepharoconjunctivitis Grade.

Time frame: Baseline to 15 days. Mean (Standard Deviation). Unit: Score on a scale

Measure	Loteprednol Etabonate and Tobramycin n = 34	Loteprednol Etabonate n = 35	Tobramycin n = 34	Vehicle n = 33
Value	-11.41 (3.29)	-11.23 (3.98)	-10.68 (4.71)	-10.30 (5.19)

Population analysed: Study eye, ITT Population, Non-missing data

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 15 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Loteprednol Etabonate and Tobramycin	2 of 34 (5.9%)	2 of 34 (5.9%)	Not reported
Loteprednol Etabonate	2 of 35 (5.7%)	2 of 35 (5.7%)	Not reported
Tobramycin	2 of 34 (5.9%)	2 of 34 (5.9%)	Not reported
Vehicle	1 of 33 (3%)	2 of 33 (6.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Conjunctivitis

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy
Allergic Conjunctivitis
Recruiting
Daydrop® Triple Action for Allergic Eye Symptoms
Allergic Conjunctivitis of Both Eyes
Not yet recruitingPhase 4
Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing loteprednol etabonate and tobramycin, loteprednol etabonate and Tobramycin in people with Conjunctivitis, run by Bausch & Lomb Incorporated at 1 site in United States.

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 4 inclusion and 5 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 24 Mar 2015. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 11 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in the Total Blepharoconjunctivitis Grade. (time frame: Baseline to 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 NCT00705159.

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 24 Mar 2015.