Trial Outcomes & Findings for Comparison of Tetracaine 0.5% and Lidocaine 2% Jelly for Topical Phacoemulsification Cataract Surgery (NCT NCT00827073)

Results Overview

Within 3 hours from time of culture acquisition, the samples will be vortexed for 30 seconds and 100µl aliquots will be plated onto 5% sheep blood and chocolate agar plates. These plates will be incubated with 5% carbon dioxide at 35˚ C for 72 hours. After 72 hours all plates will be read for colony count and identification of all isolates will be performed using routine microbiological methods. The natural log of bacterial bacterial colony count will be used for the outcome measure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

(1) Pre-antibiotics swab, and (2) Post-study medication (pre surgery)

Results posted on

2014-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	Tetracaine 5% Drop betadine: betadine 5%, topical anesthetic drop	Lidocaine 2% Jelly betadine: betadine 5% Anesthetic: lidocaine 2% jelly
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Tetracaine 0.5% and Lidocaine 2% Jelly for Topical Phacoemulsification Cataract Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tetracaine 5% Drop n=20 Participants betadine: betadine 5% topical anesthetic	Lidocaine 2% Jelly n=20 Participants betadine: betadine 5% anesthetic	Total n=40 Participants Total of all reporting groups
Age, Continuous	70.0 year STANDARD_DEVIATION 7.4 • n=5 Participants	68.4 year STANDARD_DEVIATION 11.8 • n=7 Participants	69.2 year STANDARD_DEVIATION 9.8 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: (1) Pre-antibiotics swab, and (2) Post-study medication (pre surgery)

Within 3 hours from time of culture acquisition, the samples will be vortexed for 30 seconds and 100µl aliquots will be plated onto 5% sheep blood and chocolate agar plates. These plates will be incubated with 5% carbon dioxide at 35˚ C for 72 hours. After 72 hours all plates will be read for colony count and identification of all isolates will be performed using routine microbiological methods. The natural log of bacterial bacterial colony count will be used for the outcome measure.

Outcome measures

Outcome measures
Measure	Tetracaine 0.5% Drop n=20 Participants betadine: betadine 5% topical anesthetic	Lidocaine 2% Jelly n=20 Participants betadine: betadine 5% Anesthetic
Change in Ln(Bacterial Colony Count) From Pre-antibiotic Administration to Post Study Medication Swabs	-0.14 Ln(bacterial colony count) Standard Deviation 0.67	-0.52 Ln(bacterial colony count) Standard Deviation 1.85

PRIMARY outcome

Timeframe: (1) Pre-antibiotics swab and (2) Post-study medication (pre surgery)

Outcome measures

Outcome measures
Measure	Tetracaine 0.5% Drop n=20 Participants betadine: betadine 5% topical anesthetic	Lidocaine 2% Jelly n=20 Participants betadine: betadine 5% Anesthetic
Number of Bacterial Species in Pre-antibiotic Administration and in Post Study Medication Swabs pre number of bacterial spices	1 bacterial spceies Standard Deviation 0	1 bacterial spceies Standard Deviation 0
Number of Bacterial Species in Pre-antibiotic Administration and in Post Study Medication Swabs post surgery number of bacterial speices	1 bacterial spceies Standard Deviation 0	1 bacterial spceies Standard Deviation 0

Adverse Events

Tetracaine 0.5% Drop

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lidocaine 2% Jelly

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joseph Selem, MD

Robert Cizik Eye Clinic

Phone: 713-559-5263

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place