CompletedNCT00420628Updated Oct 7, 2011Results posted

Pediatric Zylet Safety and Efficacy Study

A Phase 4 interventional study of loteprednol etabonate/tobramycin opthalmic suspension and vehicle in Chalazion and Hordeolum, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged Up to 6 Years. Per ClinicalTrials.gov, last updated 2011-10-07.

Sponsored by Bausch & Lomb Incorporated · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 108
Allocation: Randomized
Ages: Up to 6 Years
Sex: All

Study 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)

Conditions studied

Chalazion
Hordeolum

In context

Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 219 studies on the registry; 7 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 41 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Up to 6 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 108 participants (actual)

Study arms

Experimental
Loteprednol/Tobramycin
0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension
Drug: loteprednol etabonate/tobramycin opthalmic suspension
Placebo comparator
Vehicle
Vehicle
Drug: vehicle

Interventions

Drugloteprednol etabonate/tobramycin opthalmic suspension
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.
Also known as: Zylet
Drugvehicle
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.

What researchers measure

Primary outcomes

Treatment Emergent Adverse Events
Study eye - Safety Population, At all visits 1,2,3
Time frame: day 1, day 8, day 15

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Visit 3 (day 15)

Results

Posted Sep 22, 2010

Participant flow

108 subjects aged 0-6 years with lid inflammation were recruited from 15 clinic locations in the US. First subject was enrolled on 11/07/2006, last subject visit was 1/5/2009.

Participant flow — Overall Study
Milestone	Loteprednol/Tobramycin	Vehicle
Started	72	36
Completed	63	32
Not completed	9	4
Withdrew: Withdrawn by parent or gaurdian	5	2
Withdrew: Lost to follow-up	3	2
Withdrew: Adverse event	1	0

Outcome measures

SecondaryInvestigators 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.

Time frame:: Visit 3, day 8
Reported as:: Number · Participants

Investigators Global Assessment of the Clinical Condition
Participants	Loteprednol/Tobramycin	Vehicle
Improved	36 (44.0 to 69.5)	17 (34.7 to 70.9)
Unchanged	25	13
Worse	2	2

PrimaryTreatment Emergent Adverse Events

Study eye - Safety Population, At all visits 1,2,3

Time frame:: day 1, day 8, day 15
Reported as:: Number · participants

Treatment Emergent Adverse Events
participants	Loteprednol/Tobramycin	Vehicle
Conjunctivitis	2	0
Meibomianitis	1	1
Eyelid edema	0	1

SecondaryAssessment 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.

Time frame:: Visit 1 (day 1)
Reported as:: Mean · Units on a scale 0-4

Assessment of Ocular Signs in the Study Eye - Visit 1
Units on a scale 0-4	Loteprednol/Tobramycin	Vehicle
Lid Edema	1.97 ± 0.84	2.06 ± 0.95
Lid Erythema	1.98 ± 1.10	1.82 ± 1.22
Palpebral Conjunctival Injection	1.85 ± 1.13	1.79 ± 0.98
Meibomian Plugging	1.44 ± 1.04	1.59 ± 1.26

SecondaryAssessment 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.

Time frame:: Visit 2 (day 8)
Reported as:: Mean · Units on a scale 0-4

Assessment of Ocular Signs in the Study Eye - Visit 2
Units on a scale 0-4	Loteprednol/Tobramycin	Vehicle
Lid Edema	1.47 ± 0.92	1.38 ± 0.94
Lid Erythema	1.41 ± 1.01	1.47 ± 1.08
Palpebral Conjunctival Injection	1.41 ± 1.01	1.16 ± 0.92
Meibomian Plugging	1.06 ± 1.02	1.00 ± 1.11

SecondaryAssessment 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.

Time frame:: Visit 3 (day 15)
Reported as:: Mean · Units on a scale 0-4

Assessment of Ocular Signs in the Study Eye - Visit 3
Units on a scale 0-4	Loteprednol/Tobramycin	Vehicle
Lid Edema	1.03 ± 0.90	1.41 ± 1.10
Lid Erythema	1.00 ± 0.88	1.50 ± 1.14
Palpebral Conjunctival Injection	1.11 ± 0.95	1.09 ± 1.09
Meibomian Plugging	0.86 ± 1.12	1.16 ± 1.22

Adverse events

Collected over 14 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Loteprednol/Tobramycin	—	1/72 (1.4%)	0/72 (0%)
Vehicle	—	0/36 (0%)	0/36 (0%)

Most frequent serious events

Most frequent serious events
Event	Loteprednol/Tobramycin	Vehicle
bilateral subdural hematomaVascular disorders	1/72	0/36

Baseline characteristics

Age, Customized
Age, Customized(participants)	Loteprednol/Tobramycin	Vehicle	Total
Age 0-6 years	72	36	108

Sex: Female, Male
Sex: Female, Male(Participants)	Loteprednol/Tobramycin	Vehicle	Total
Female	37	23	60
Male	35	13	48

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Loteprednol/Tobramycin	Vehicle	Total
Asian	3	1	4
Black or African American	10	7	17
White	52	25	77
Other	7	3	10

Study locations

1 site

Pediatric Ophthalmology of Erie
Erie, Pennsylvania 16501, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 7, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00420628
Lead sponsor: Bausch & Lomb Incorporated
Responsible party: Sponsor
First posted: Jan 11, 2007
Start date: Nov 2006
Primary completion: Jan 2009
Completion: Jun 2009
Results posted: Sep 22, 2010
Last update: Oct 7, 2011

Study contacts

Timothy L Comstock, OD

study director · Bausch & Lomb Incorporated

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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Other studies in this condition

Hordeolum

Other studies from this sponsor

Bausch & Lomb Incorporated

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Pediatric Zylet Safety and Efficacy Study

Study summary

Conditions studied

In context

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria