Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
108 participants
INTERVENTIONAL
2006-11-30
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Loteprednol/Tobramycin
0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension
loteprednol 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.
Vehicle
Vehicle
vehicle
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.
Interventions
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loteprednol 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.
vehicle
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
ALL
No
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Timothy L Comstock, OD
Role: STUDY_DIRECTOR
Bausch & Lomb Incorporated
Locations
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Pediatric Ophthalmology of Erie
Erie, Pennsylvania, United States
Countries
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Other Identifiers
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459
Identifier Type: -
Identifier Source: org_study_id