Pediatric Zylet Safety and Efficacy Study

NCT00420628 | Completed Phase 4 Results

• 1 other identifier: 459
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Chalazion; Hordeolum

Outcome Measures

Primary Outcomes (1)

• Treatment Emergent Adverse Events

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

  day 1, day 8, day 15

Secondary Outcomes (4)

• Investigators Global Assessment of the Clinical Condition

  Visit 3, day 8

• Assessment of Ocular Signs in the Study Eye - Visit 1

  Visit 1 (day 1)

• Assessment of Ocular Signs in the Study Eye - Visit 2

  Visit 2 (day 8)

• Assessment of Ocular Signs in the Study Eye - Visit 3

  Visit 3 (day 15)

Study Arms (2)

Loteprednol/Tobramycin

EXPERIMENTAL

0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension

Drug: loteprednol etabonate/tobramycin opthalmic suspension

Vehicle

PLACEBO COMPARATOR

Vehicle

Drug: vehicle

Interventions

loteprednol etabonate/tobramycin opthalmic suspension DRUG

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

Loteprednol/Tobramycin

vehicle DRUG

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.

Vehicle

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Pediatric Ophthalmology of Erie

Erie, Pennsylvania, 16501, United States

Location

MeSH Terms

Conditions

Chalazion; Hordeolum

Interventions

Loteprednol Etabonate

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Eyelid Diseases; Eye Diseases; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Timothy Comstock OD
• Organization: Bausch & Lomb

tcomstock@bausch.com

(585) 338-6631

Study Officials

• Timothy L Comstock, OD

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2007
• First Posted: January 11, 2007
• Study Start: November 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 7, 2011
• Results First Posted: September 22, 2010

Record last verified: 2011-09

Locations

US (1)