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

NCT ID: NCT01028027

Last Updated: 2012-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 357 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Loteprednol and tobramycin

Loteprednol etabonate and tobramycin ophthalmic suspension

Group Type: EXPERIMENTAL

Loteprednol and tobramycin

Intervention Type: DRUG

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

Tobramycin and dexamethasone

Tobramycin and dexamethasone ophthalmic suspension

Group Type: ACTIVE_COMPARATOR

Tobramycin and dexamethasone

Intervention Type: DRUG

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

Interventions

Loteprednol and tobramycin

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

Intervention Type: DRUG

Tobramycin and dexamethasone

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

Intervention Type: DRUG

Other Intervention Names

Zylet; Tobradex

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esther Chu

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Bausch & Lomb Inc

Singapore, , Singapore

Countries

Singapore

References

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.

Reference Type: DERIVED

PMID: 22256909 (View on PubMed)

Other Identifiers

617

Identifier Type: -

Identifier Source: org_study_id