Overview

Pediatric Zylet Safety and Efficacy Study

Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
0
Participant gender:
All
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)
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bausch & Lomb Incorporated
Treatments:
Loteprednol Etabonate
Tobramycin
Criteria
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:

- 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