A Clinical Safety and Efficacy Evaluation of Zylet (Loteprednol Etabonate and Tobramycin Ophthalmic Suspension) vs. Tobradex (Tobramycin and Dexamethasone Ophthalmic Suspension) in the Treatment of Blepharokeratoconjunctivitis
Sponsor study identifier
interventional
276
1 country
1
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2007
Actual (reported)Study Completion
June 2007
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2007
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
March 12, 2007
Actual (reported)March 14, 2007
Actual (reported)June 2007
Actual (reported)June 2007
Actual (reported)The primary efficacy endpoint for this study is the change from baseline to Day 15 in the signs and symptoms composite score
15 days
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
Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3% (Zylet)
Tobradex (tobramycin and dexamethasone ophthalmic suspension, 0.3%/0.1%), US marketed product (Alcon) from commercial lots.
Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.
Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Loteprednol etabonate and tobramycin ophthalmic suspension
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Tobramycin and dexamethasone ophthalmic suspension
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordCornerstone Eye Care
High Point, North Carolina, 27262, United States
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.
Timothy Comstock, OD
Bausch & Lomb Incorporated
276 participants (actual enrollment reported by the registry).
First Submitted
March 12, 2007
First Posted
March 14, 2007
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 2007
Actual (reported)Study Completion
June 2007
Actual (reported)Last Updated
December 9, 2011
Record last verified: 2011-12
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Source: ClinicalTrials.gov.
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