Pediatric Zylet Safety and Efficacy Study

Chalazion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420628
• Other study ID #: 459
• Status: Completed
• Phase: Phase 4
• First received: January 8, 2007
• Last updated: September 30, 2011
• Start date: November 2006
• Est. completion date: June 2009

Study information

• Verified date: September 2011
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chalazion
• Hordeolum

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Pediatric Ophthalmology of Erie	Erie	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Emergent Adverse Events	Study eye - Safety Population, At all visits 1,2,3	day 1, day 8, day 15	No
Secondary	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.	Visit 3, day 8	No
Secondary	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.	Visit 1 (day 1)	No
Secondary	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.	Visit 2 (day 8)	No
Secondary	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.	Visit 3 (day 15)	No