Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis

NCT01028027 | Completed Phase 3 Results

• 1 other identifier: 617
• Study Type: interventional
• Target: 357
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the safety and efficacy of loteprednol etabonate \[LE\] and tobramycin ophthalmic suspension versus tobramycin and dexamethasone ophthalmic suspension in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis (BKC).

Conditions

Conjunctivitis; Keratitis; Blepharitis

Keywords

Blepharokeratoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population

  The change from baseline (CFB) to Day 15 (Visit 4) in the ocular signs and symptoms composite score. Ocular signs and symptoms were collected for study eyes at each study visit using a 0-4 grading scale, assessed as 0 = none, 1 = minimal/trace, 2 = mild, 3 = moderate, and 4 = severe. The signs and symptoms composite score was the sum of each individual sign or symptom score. Per protocol population (PP).

  Baseline, Day 15

Secondary Outcomes (5)

• Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population

  Baseline, Day 15

• Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population

  Baseline, Day 8

• Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population

  Baseline, Day 8

• Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population

  Baseline, Day 3

• Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population

  Baseline, Day 3

Study Arms (2)

Loteprednol and tobramycin

EXPERIMENTAL

Loteprednol etabonate and tobramycin ophthalmic suspension

Drug: Loteprednol and tobramycin

Tobramycin and dexamethasone

ACTIVE COMPARATOR

Tobramycin and dexamethasone ophthalmic suspension

Drug: Tobramycin and dexamethasone

Interventions

Loteprednol and tobramycin DRUG

Loteprednol etabonate and tobramycin ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.

Also known as: Zylet

Loteprednol and tobramycin

Tobramycin and dexamethasone DRUG

Tobramycin and dexamethasone ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.

Also known as: Tobradex

Tobramycin and dexamethasone

Eligibility Criteria

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

You may qualify if:

• Subjects must have a clinical diagnosis of BKC in at least one eye
• Subjects must be willing to discontinue contact lens use for the duration of the study
• Subjects who are able and willing to comply with all treatment and follow- up/study procedures.

You may not qualify if:

• Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
• Subjects who have any uncontrolled systemic disease or debilitating disease.
• Subjects who have a known hypersensitivity to the study drugs or their components (including benzalkonium chloride) or contraindications to tobramycin or ocular corticosteroids.
• Subjects who use any topical or systemic ophthalmic medications listed as disallowed in the study protocol, within the specified time frame prior to Visit 1.
• Subjects who have a disease or conditions which the Investigator determines could interfere with the safety and efficacy evaluations of the study drug.
• Subjects having ocular surgery (including laser surgery) in either eye within the past three months.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb Inc

Singapore, 556741, Singapore

Location

Related Publications (1)

• Chen M, Gong L, Sun X, Gu Y, He X, Qu J, Wang L, Zhang M, Zhong X. A multicenter, randomized, parallel-group, clinical trial comparing the safety and efficacy of loteprednol etabonate 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of Chinese patients with blepharokeratoconjunctivitis. Curr Med Res Opin. 2012 Mar;28(3):385-94. doi: 10.1185/03007995.2012.659723. Epub 2012 Feb 7.

  PMID: 22256909 DERIVED

MeSH Terms

Conditions

Conjunctivitis; Keratitis; Blepharitis

Interventions

Loteprednol Etabonate; Tobramycin; Dexamethasone; Tobramycin, Dexamethasone Drug Combination

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Corneal Diseases; Eyelid Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids, Fluorinated; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

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

tuyen.ong@bausch.com

(973) 360-6389

Study Officials

• Esther Chu

  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 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2009
• First Posted: December 9, 2009
• Study Start: October 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: February 28, 2012
• Results First Posted: September 15, 2011

Record last verified: 2012-02

Locations

SG (1)