Zylet vs TobraDex in Blepharokeratoconjunctivitis

NCT00447577 | Completed Phase 4

• 1 other identifier: 512
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the safety and efficacy of Zylet vs. Tobradex in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis

Conditions

Blepharokeratoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint for this study is the change from baseline to Day 15 in the signs and symptoms composite score

  15 days

Secondary Outcomes (8)

• The distribution of Investigator global assessment at each visit.

  Visit 2, 3 & 4

• The percentage of eyes that were considered improved or cured at each visit based on the Investigator global assessment.

  Visit 2, 3 & 4

• The change from baseline to Day 7 (Visit 3) and to Day 3 (Visit 2) in the signs and symptoms composite score.

  Visit 2 & 3

• The change from baseline to each visit in the signs composite score and the symptoms composite score.

  Visit 1, 2, 3 & 4

• The change from baseline to each visit in the Blepharitis signs composite score, the conjunctivitis signs composite score, and the Keratitis signs composite score.

  Visit 1, 2, 3 & 4

Study Arms (2)

Zylet

EXPERIMENTAL

Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3% (Zylet)

Drug: Loteprednol etabonate and tobramycin ophthalmic suspension

Tobradex

ACTIVE COMPARATOR

Tobradex (tobramycin and dexamethasone ophthalmic suspension, 0.3%/0.1%), US marketed product (Alcon) from commercial lots.

Drug: Tobramycin and dexamethasone ophthalmic suspension

Interventions

Loteprednol etabonate and tobramycin ophthalmic suspension DRUG

Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.

Zylet

Tobramycin and dexamethasone ophthalmic suspension DRUG

Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.

Tobradex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be at least 18 years of age
• Must be able and willing to comply with all treatment and follow up procedures
• Must have the ability to understand and sign an Informed Consent Form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization
• Must be able to self-administer drugs
• Must have a clinical diagnosis of blepharokeratoconjunctivitis in at least one eye (total Ocular Signs and Symptoms score of at least 10, with at least one ocular sign and one ocular symptom each having a score of Grade 2 level or higher)
• Women of childbearing potential must be sexually inactive or using an approved birth control methods and must have a negative urine pregnancy test
• Must be willing to discontinue contact lens use for the duration of the study
• Must have pin-holed Snellen visual acuity equal to or better than 20/40 in both eyes

You may not qualify if:

• Any uncontrolled systemic disease or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis)
• Known hypersensitivity to the study drugs or their components (including benzalkonium chloride) or contraindications to tobramycin or ocular corticosteroids
• Use of any systemic or topical ophthalmic non-steroidal anti-inflammatory agents, analgesics, and antihistamines that cannot be discontinued during the study
• Use of any topical ophthalmic medications, including tear substitutes, within 2 hours before and that cannot be discontinued during the study
• Use of any systemic or topical ophthalmic antibiotic agents within 72 hours before and that cannot be discontinued during the study
• Use of any systemic or topical ophthalmic corticosteroid agents within 7 days before and that cannot be discontinued during the study
• Use of any systemic or topical ophthalmic mast cell stabilizers within 14 days before and that cannot be discontinued during the study
• Use of any topical ophthalmic immunosuppressant (e.g. Restasis) agents within 30 days before and that cannot be discontinued during the study
• Suspected preseptal cellulites, or any other disease conditions which the Investigator determines could interfere with the safety and efficacy evaluations of the study drug
• Suspected dacrocystitis
• Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this study
• Ocular surgery (including laser surgery) in either eye within the past 3 months

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Cornerstone Eye Care

High Point, North Carolina, 27262, United States

Location

Related Publications (1)

• White EM, Macy JI, Bateman KM, Comstock TL. Comparison of the safety and efficacy of loteprednol 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of blepharokeratoconjunctivitis. Curr Med Res Opin. 2008 Jan;24(1):287-96. doi: 10.1185/030079908x253898.

  PMID: 18062846 DERIVED

MeSH Terms

Interventions

Loteprednol Etabonate; Tobramycin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Timothy Comstock, OD

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2007
• First Posted: March 14, 2007
• Study Start: January 1, 2007
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: December 9, 2011

Record last verified: 2011-12

Locations

US (1)