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

• ClinicalTrials.gov Identifier: NCT01028027
• Recruitment Status: Completed
• First Posted: December 9, 2009
• Results First Posted: September 15, 2011
• Last Update Posted: February 28, 2012
• Sponsor: Bausch & Lomb Incorporated
• Information provided by (Responsible Party): Bausch & Lomb Incorporated

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Conjunctivitis; Keratitis; Blepharitis	Drug: Loteprednol and tobramycin; Drug: Tobramycin and dexamethasone	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 357 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: A Clinical Safety and Efficacy Evaluation of Zylet® Versus Tobradex in the Treatment of Blepharokeratoconjunctivitis
• Study Start Date: October 2009
• Actual Primary Completion Date: February 2010
• Actual Study Completion Date: March 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Loteprednol and tobramycin; Loteprednol etabonate and tobramycin ophthalmic suspension	Drug: Loteprednol and tobramycin; Loteprednol etabonate and tobramycin ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.; Other Name: Zylet
Active Comparator: Tobramycin and dexamethasone; Tobramycin and dexamethasone ophthalmic suspension	Drug: Tobramycin and dexamethasone; Tobramycin and dexamethasone ophthalmic suspension administered to study eye 4 times a day (QID) for 14 days.; Other Name: Tobradex

Outcome Measures

Primary Outcome Measures :

1. Signs and Symptoms Composite Score - Change From Baseline to Day 15 - PP Population [ Time Frame: Baseline, Day 15 ]
   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).

Secondary Outcome Measures :

1. Signs and Symptoms Composite Score - Change From Baseline to Day 15 - ITT Population [ Time Frame: Baseline, Day 15 ]
   The CFB to Day 15 in the 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. ITT population
2. Signs and Symptoms Composite Score - Change From Baseline to Day 8 - PP Population [ Time Frame: Baseline, Day 8 ]
   The CFB to Day 8 (Visit 3) in the 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.
3. Signs and Symptoms Composite Score - Change From Baseline to Day 8 - ITT Population [ Time Frame: Baseline, Day 8 ]
   The CFB to Day 8 in the 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. ITT population
4. Signs and Symptoms Composite Score Change From Baseline to Day 3 - PP Population [ Time Frame: Baseline, Day 3 ]
   The CFB to Day 3 in the 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. PP population.
5. Signs and Symptoms Composite Score Change From Baseline to Day 3 - ITT Population [ Time Frame: Baseline, Day 3 ]
   The CFB to Day 3 in the 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. ITT population.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

Singapore

Bausch & Lomb Inc

Singapore, Singapore, 556741

Sponsors and Collaborators

Bausch & Lomb Incorporated

Investigators

• Study Director: Esther Chu; Bausch & Lomb Incorporated

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01028027
• Other Study ID Numbers: 617
• First Posted: December 9, 2009
• Results First Posted: September 15, 2011
• Last Update Posted: February 28, 2012
• Last Verified: February 2012

Keywords provided by Bausch & Lomb Incorporated:

Blepharokeratoconjunctivitis

Additional relevant MeSH terms:

Conjunctivitis; Keratitis; Blepharitis; Conjunctival Diseases; Eye Diseases; Corneal Diseases; Eyelid Diseases; Loteprednol Etabonate; Tobramycin; Dexamethasone; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Anti-Bacterial Agents; Anti-Infective Agents; Anti-Allergic Agents