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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


Phase 4
N/A
6 Years
Not Enrolling
Both
Chalazion, Hordeolum

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Treatment Emergent Adverse Events

Outcome Description:

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

Outcome Time Frame:

day 1, day 8, day 15

Safety Issue:

No

Principal Investigator

Timothy L Comstock, OD

Investigator Role:

Study Director

Investigator Affiliation:

Bausch & Lomb Incorporated

Authority:

United States: Food and Drug Administration

Study ID:

459

NCT ID:

NCT00420628

Start Date:

November 2006

Completion Date:

June 2009

Related Keywords:

  • Chalazion
  • Hordeolum
  • Chalazion
  • Hordeolum

Name

Location

Pediatric Ophthalmology of ErieErie, Pennsylvania  16501