Management decision
Evaluation of the Safety and Efficacy of VIGADEXA Ophthalmic Gel Compared to VIGADEXA Ophthalmic Solution in Preventing Inflammation and Infection Following Cataract Surgery
Sponsor study identifier
interventional
0
0 countries
N/A
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to compare VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.075%) ophthalmic gel to VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.1%) ophthalmic solution in the prevention of postoperative inflammation and infection.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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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 19, 2012
Actual (reported)January 24, 2012
Actual (reported)March 2014
Date type not reportedThis date has not been verified as actual or estimated.
October 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Percentage of patients with a score of 0 (<5 cells) for cells in the anterior chamber
As assessed by the investigator during slit-lamp examination.
Day 15 post-operative
Percentage of patients with no clinically evidenced bacterial infection
As assessed by the investigator during slit-lamp examination.
Day 15 post-operative
Cells in the anterior chamber (study eye)
Day 15 post-operative
Ocular pain (study eye)
Day 15 post-operative
Inflammatory reaction (study eye)
Day 15 post-operative
VIGADEXA ophthalmic gel topically administered TID to the operative eye starting the day before surgery, continuing on the day of surgery, and for 15 days following surgery.
VIGADEXA ophthalmic solution topically administered QID to the operative eye starting the day before surgery, continuing on the day of surgery, and for 15 days following surgery.
One ribbon (approximately 1-1.5 cm) administered topically in the conjunctival sac of the study eye three times daily (TID), starting the day before surgery (Day -1) and continuing on the day of surgery and for 15 days following surgery.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel)
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
Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record0 participants (actual enrollment reported by the registry).
First Submitted
January 19, 2012
First Posted
January 24, 2012
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Safety and Efficacy of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus
One drop administered topically in the conjunctival sac of the study eye four times daily (QID), starting the day before surgery (Day -1) and continuing on the day of surgery and for 15 days following surgery.
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Primary Completion
October 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 26, 2014
Record last verified: 2014-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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