Trial Outcomes & Findings for Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery (NCT NCT00575380)

NCT ID: NCT00575380

Last Updated: 2011-09-22

Results Overview

Nominal time is scheduled time relative to administration of the first eye drop

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 116 participants
• Primary outcome timeframe: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312
• Results posted on: 2011-09-22

Participant Flow

Participant milestones

Measure	Azasite	Vigamox
Overall Study STARTED	58	58
Overall Study COMPLETED	57	55
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Azasite	Vigamox
Overall Study Withdrawal by Subject	1	0
Overall Study Adverse Event	0	1
Overall Study Various	0	2

Baseline Characteristics

Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery

Baseline characteristics by cohort

Measure	Azasite n=58 Participants	Vigamox n=58 Participants	Total n=116 Participants Total of all reporting groups
Age Continuous	71.0 years STANDARD_DEVIATION 7.57 • n=5 Participants	66.3 years STANDARD_DEVIATION 10.02 • n=7 Participants	68.6 years STANDARD_DEVIATION 9.15 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	28 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	30 Participants n=7 Participants	54 Participants n=5 Participants

PRIMARY outcome

Timeframe: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312

Nominal time is scheduled time relative to administration of the first eye drop

Outcome measures

Measure	Azasite n=57 Participants	Vigamox n=55 Participants
Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) Timepoint 1 - 1 hr (AzaSite and Vigamox)	40.4 ug/g Standard Deviation 19.7752	5.747 ug/g Standard Deviation 3.4775
Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) Timepoint 2 - 12 hrs (AzaSite)/8 hrs (Vigamox)	33.55 ug/g Standard Deviation 11.81	1.051 ug/g Standard Deviation .8099
Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) Timepoint 3 - 48 hrs (AzaSite and Vigamox)	559.733 ug/g Standard Deviation 1011.658	1.129 ug/g Standard Deviation 1.1673
Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) Timepoint 4 - 49 hrs (AzaSite and Vigamox)	98.6 ug/g Standard Deviation 4.535	15.754 ug/g Standard Deviation 15.4107
Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) Timepoint 5 -72 hrs (AzaSite)/56 hrs (Vigamox)	287.75 ug/g Standard Deviation 433.4355	.862 ug/g Standard Deviation .6801
Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) Timepoint 6 - 144 hrs (AzaSite and Vigamox)	175.017 ug/g Standard Deviation 88.9250	.305 ug/g Standard Deviation .0917
Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) Timepoint 7 - 145 hrs (AzaSite and Vigamox)	269.46 ug/g Standard Deviation 316.2821	5.432 ug/g Standard Deviation 4.0756
Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) Timepoint 8 - 168 hrs (AzaSite and Vigamox)	261.125 ug/g Standard Deviation 169.1224	.322 ug/g Standard Deviation .1792
Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) Timepoint 9 - 216 hrs (AzaSite and Vigamox)	273.9 ug/g Standard Deviation 160.4984	.165 ug/g Standard Deviation .1974
Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) Timepoint 10 - 312 (AzaSite and Vigamox)	63.867 ug/g Standard Deviation 51.1578	.011 ug/g Standard Deviation .0098

SECONDARY outcome

Timeframe: Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312

Outcome measures

Measure	Azasite n=57 Participants	Vigamox n=55 Participants
Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) Timepoint 8 - 168 hrs (AzaSite and Vigamox)	.035 ug/mL Standard Deviation .0276	.059 ug/mL Standard Deviation .0265
Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) Timepoint 1- 1 hr (AzaSite and Vigamox)	.022 ug/mL Standard Deviation .0297	.582 ug/mL Standard Deviation .506
Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) Timepoint 2- 12 hrs (AzaSite)/ 8 hrs (Vigamox)	.088 ug/mL Standard Deviation .0084	.113 ug/mL Standard Deviation .0729
Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) Timepoint 3 - 48 hrs (AzaSite and Vigamox)	.047 ug/mL Standard Deviation .0515	.079 ug/mL Standard Deviation .0543
Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) Timepoint 4 - 49 hrs (AzaSite and Vigamox)	.023 ug/mL Standard Deviation .0183	.765 ug/mL Standard Deviation .5657
Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) Timepoint 5 - 72 hrs (AzaSite)/ 56 hr (Vigamox)	.02 ug/mL Standard Deviation .0099	.084 ug/mL Standard Deviation .0261
Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) Timepoint 6 - 144 hrs (AzaSite and Vigamox)	.026 ug/mL Standard Deviation .0175	.225 ug/mL Standard Deviation .1456
Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) Timepoint 7 - 145 hrs (AzaSite and Vigamox)	.052 ug/mL Standard Deviation .0694	.669 ug/mL Standard Deviation .402
Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) Timepoint 9 - 216 hrs (AzaSite and Vigamox)	.028 ug/mL Standard Deviation .0353	.071 ug/mL Standard Deviation .0845
Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) Timepoint 10 - 312 hrs (AzaSite and Vigamox)	.011 ug/mL Standard Deviation .0102	.017 ug/mL Standard Deviation .0189

Adverse Events

Azasite

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Vigamox

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Azasite n=58 participants at risk	Vigamox n=58 participants at risk
Investigations Intraocular pressure increased	5.2% 3/58 • Number of events 3	3.4% 2/58 • Number of events 2

Additional Information

Mike Schiewe

Inspire

Phone: 919-941-9777

Email: mschiewe@inspirepharm.com

Results disclosure agreements

• Principal investigator is a sponsor employee PI cannot publish or discuss trial results until written communication is received from Inspire
• Publication restrictions are in place

Restriction type: OTHER