ChalazionPhase 4NCT00420628
Pediatric Zylet Safety and Efficacy Study
A Phase 4 study testing loteprednol etabonate/tobramycin opthalmic suspension in people with Chalazion and Hordeolum, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum) Read more about this study
- Who is it for?
- Ages Up to 6 years
- What is being tested?
- loteprednol etabonate/tobramycin opthalmic suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Jun 2009
- 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 Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child, 0 to 6 years of age, any sex and race
- Subject must have a clinical diagnosis of lid inflammation (e.g. Chalazion/Hordeolum) in at least one eye. If both eyes are diagnosed with lid inflammation, both eyes will be treated
- In good health (no current or past relevant medical history), based on the judgment of the investigator
- Parent/guardian is able and willing to follow instructions and provide informed consent
Who cannot join
- Known hypersensitivity to corticosteroids, loteprednol etabonate, or any component of the study medication
- Known hypersensitivity to aminoglycosides, tobramycin, or any component of the study medication
- Use of concurrent ocular therapy with non-steroidal anti-inflammatory agent (NSAID), mast cell stabilizer, antihistamine, or decongestant within 48 hours before and during the study
- Use of oral or topical ophthalmic corticosteroids (other than study medication) within 48 hours before and during the study
- Use of systemic antibiotics within 72 hours before and during the 14 day study medication treatment duration
- Use of topical ophthalmic antibiotics (other than the study medication) within 72 hours before and during the study
Show all 12Show fewer
- History of ocular surgery, including laser procedures, within the past six months
- Anticipation that surgical intervention for lid inflammation will be required prior to completion of the study
- Subjects with suspected vernal conjunctivitis, glaucoma of any kind, viral or bacterial conjunctivitis, preseptal cellulitis requiring systemic antibiotics, dacryocystitis, uveitis, or any other disease conditions that could interfere with the safety and efficacy evaluations of the study medication
- History of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study
- Participation in an ophthalmic drug or device research study within 30 days prior to entry in this study
- Unlikely to comply with the protocol instructions for any reason
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Ophthalmology of Erie
Erie, Pennsylvania, 16501
About this study
Official title: A Safety and Efficacy Study of Zylet® (Loteprednol Etabonate 0.5% and Tobramycin 0.3% Ophthalmic Suspension) Compared to Vehicle in the Management of Lid Inflammation (Chalazion/Hordeolum) in Pediatric Subjects
A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum)
- Being tested
- loteprednol etabonate/tobramycin opthalmic suspension, vehicle
- Medical subject headings
- Chalazion, Hordeolum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loteprednol etabonate/tobramycin opthalmic suspensionDrug
Also called Zylet
Topical ophthalmic drug: 0.5% loteprednol etabonate with 0.3% tobramycin 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication.
vehicleDrug
topical ophthalmic vehicle was applied 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication.
| Study group | Role | What they receive |
|---|---|---|
| Loteprednol/Tobramycin | Experimental | 0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension Receives: Drug: loteprednol etabonate/tobramycin opthalmic suspension |
| Vehicle | Placebo comparator | Vehicle Receives: Drug: vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events
Study eye - Safety Population, At all visits 1,2,3
Measured: day 1, day 8, day 15
Secondary outcomes (4)
Investigators Global Assessment of the Clinical Condition
The efficacy endpoints for this study consisted of reduction of inflammation as measured by the IGA of the clinical condition. Changes in clinical condition measured as improved, unchanged or worsened.
Measured: Visit 3, day 8
Assessment of Ocular Signs in the Study Eye - Visit 1
Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Measured: Visit 1 (day 1)
Assessment of Ocular Signs in the Study Eye - Visit 2
Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Measured: Visit 2 (day 8)
Assessment of Ocular Signs in the Study Eye - Visit 3
Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Measured: Visit 3 (day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startNov 2006
- Primary completionJan 2009
- Study completionJun 2009
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 ChalazionStudies 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy L Comstock, OD, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420628
- Sponsor's protocol ID
- 459
- Status last verified
- Sep 2011
- First submitted
- 8 Jan 2007
- Last updated
- 7 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of Zylet® (Loteprednol Etabonate 0.5% and Tobramycin 0.3% Ophthalmic Suspension) Compared to Vehicle in the Management of Lid Inflammation (Chalazion/Hordeolum) in Pediatric Subjects
- ClinicalTrials.gov ID
- NCT00420628
- Acronym / sponsor ID
- 459
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 11 Jan 2007 (estimated)
- Results
- Posted 22 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loteprednol/Tobramycin | Experimental | Drug: loteprednol etabonate/tobramycin opthalmic suspension0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension |
| Vehicle | Placebo comparator | Drug: vehicleVehicle |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child, 0 to 6 years of age, any sex and race
- Subject must have a clinical diagnosis of lid inflammation (e.g. Chalazion/Hordeolum) in at least one eye. If both eyes are diagnosed with lid inflammation, both eyes will be treated
- In good health (no current or past relevant medical history), based on the judgment of the investigator
- Parent/guardian is able and willing to follow instructions and provide informed consent
Key exclusion criteria (12 listed)
- Known hypersensitivity to corticosteroids, loteprednol etabonate, or any component of the study medication
- Known hypersensitivity to aminoglycosides, tobramycin, or any component of the study medication
- Use of concurrent ocular therapy with non-steroidal anti-inflammatory agent (NSAID), mast cell stabilizer, antihistamine, or decongestant within 48 hours before and during the study
- Use of oral or topical ophthalmic corticosteroids (other than study medication) within 48 hours before and during the study
- Use of systemic antibiotics within 72 hours before and during the 14 day study medication treatment duration
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/tobramycin opthalmic suspensionAlso: ZyletTopical ophthalmic drug: 0.5% loteprednol etabonate with 0.3% tobramycin 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication. | Drug | Loteprednol/Tobramycin |
| vehicletopical ophthalmic vehicle was applied 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication. | Drug | Vehicle |
Primary outcome
Treatment Emergent Adverse Events
Time frame: day 1, day 8, day 15
Study eye - Safety Population, At all visits 1,2,3
4 secondary outcomes
Investigators Global Assessment of the Clinical Condition
Time frame: Visit 3, day 8
Assessment of Ocular Signs in the Study Eye - Visit 1
Time frame: Visit 1 (day 1)
Assessment of Ocular Signs in the Study Eye - Visit 2
Time frame: Visit 2 (day 8)
Assessment of Ocular Signs in the Study Eye - Visit 3
Time frame: Visit 3 (day 15)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Timothy L 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?
A Phase 4 study testing loteprednol etabonate/tobramycin opthalmic suspension in people with Chalazion and Hordeolum, 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 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 7 Oct 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. 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 22 Sep 2010). 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?
Treatment Emergent Adverse Events (time frame: day 1, day 8, day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2011.