Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis

NCT00705159 | Completed Phase 4 Results

• 1 other identifier: 550
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of Zylet in comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of blepharoconjunctivitis in pediatric subjects.

Conditions

Conjunctivitis

Keywords

Blepharokeratoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Total Blepharoconjunctivitis Grade.

  Change from baseline to visit 4 in the total blepharoconjunctivitis grade. Graded on a scale of 0-4, 0 (none), 1 (minimal/trace), 2 (mild), 3 (moderate), and 4 (severe). Grade range from 0-32.

  Baseline to 15 days

Secondary Outcomes (2)

• Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 2

  Baseline to Day 3

• Change From Baseline in Total Blepharoconjunctivitis Graded at Visit 3

  Baseline to Day 7

Study Arms (4)

Loteprednol etabonate and tobramycin

EXPERIMENTAL

Drug: Zylet (loteprednol etabonate and tobramycin)

Drug: loteprednol etabonate and tobramycin

Loteprednol etabonate

ACTIVE COMPARATOR

Drug: Lotemax (loteprednol etabonate)

Drug: loteprednol etabonate

Tobramycin

ACTIVE COMPARATOR

Drug: Tobramycin

Drug: Tobramycin

Vehicle

PLACEBO COMPARATOR

Vehicle of Zylet

Drug: Vehicle of Zylet

Interventions

loteprednol etabonate and tobramycin DRUG

Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.

Also known as: Zylet

Loteprednol etabonate and tobramycin

loteprednol etabonate DRUG

Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.

Also known as: Lotemax

Loteprednol etabonate

Tobramycin DRUG

Topical ocular administration of Tobramycin QID for 14 days.

Tobramycin

Vehicle of Zylet DRUG

Topical ocular administration of the vehicle of Zylet QID for 14 days.

Vehicle

Eligibility Criteria

• Age: 1 Week - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children 0-6 years of age.
• clinical diagnosis of blepharoconjunctivitis
• Parent/guardian must understand, be willing and able to comply with all treatment and follow-up procedures.
• Parent/guardian must understand, be willing and able to provide informed consent and Health Insurance Portability Accountability Act (HIPAA) authorization.

You may not qualify if:

• Known hypersensitivity to corticosteroids, aminoglycosides, or any component of the study medication.
• Subjects who have a history of ocular surgery, including laser procedures, within the past 6 months.
• Subjects who are monocular.
• Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study.
• Subjects who have participated in an ophthalmic drug or device research study within 30 days prior to entry in this study.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Pediatric Ophthalmology of Erie

Erie, Pennsylvania, 16501, United States

Location

MeSH Terms

Conditions

Conjunctivitis

Interventions

Loteprednol Etabonate; Tobramycin

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Tuyen Ong, MD, MRCOphth
• Organization: Bausch & Lomb Incorporated

tuyen.ong@bausch.com

(973) 360-6389

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: June 20, 2008
• First Posted: June 25, 2008
• Study Start: June 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: March 24, 2015
• Results First Posted: August 11, 2011

Record last verified: 2015-03

Locations

US (1)