Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)

• ClinicalTrials.gov Identifier: NCT00105469
• Recruitment Status: Completed
• First Posted: March 15, 2005
• Results First Posted: October 27, 2011
• Last Update Posted: December 16, 2013
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by: Merck Sharp & Dohme LLC

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Bacterial Conjunctivitis
• Interventions: Drug: AzaSite; Drug: Tobramycin
• Enrollment: 743

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	AzaSite	Tobramycin
Arm/Group Description	[Not Specified]	[Not Specified]
Period Title: Overall Study
Started	365	378
Completed	343	367
Not Completed	22	11
Reason Not Completed
Adverse Event	9	8
Protocol Violation	4	0
Withdrawal by Subject	2	3
Lost to Follow-up	1	0
Lack of Efficacy	2	0
Other Reason	4	0

Baseline Characteristics

Arm/Group Title		AzaSite	Tobramycin	Total
Arm/Group Description		Per protocol population (defined as all randomized subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward.	Per protocol population (defined as all randomized subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward.	Total of all reporting groups
Overall Number of Baseline Participants		159	157	316
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	159 participants	157 participants	316 participants
		17.9 (20.23)	22.8 (22.61)	20.4 (21.55)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	159 participants	157 participants	316 participants
	Female	81 50.9%	90 57.3%	171 54.1%
	Male	78 49.1%	67 42.7%	145 45.9%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Achieved Clinical Resolution at Visit 3
Description	Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).
Time Frame	Visit 3 (Day 6)

Outcome Measure Data

Analysis Population Description

Per protocol population (defined as all randomized

subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of

pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward.

Arm/Group Title	AzaSite	Tobramycin
Arm/Group Description:	[Not Specified]	[Not Specified]
Overall Number of Participants Analyzed	159	157
Measure Type: Number; Unit of Measure: Participants
	127	123

2. Secondary Outcome

Title	Number of Participants Who Achieved Bacterial Eradication at Visit 3
Description	Bacterial eradication is defined as eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).
Time Frame	Visit 3 (Day 6)

Outcome Measure Data

Analysis Population Description

Per protocol population (defined as all randomized

subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of

pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward.

Arm/Group Title	AzaSite	Tobramycin
Arm/Group Description:	[Not Specified]	[Not Specified]
Overall Number of Participants Analyzed	159	157
Measure Type: Number; Unit of Measure: Participants
	140	148

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	AzaSite	Tobramycin
Arm/Group Description	[Not Specified]	[Not Specified]
All-Cause Mortality
	AzaSite	Tobramycin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	AzaSite	Tobramycin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/365 (0.00%)	0/378 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	AzaSite	Tobramycin
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/365 (0.00%)	0/378 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Institution and Principal Investigator shall not publish, present or use any data or results arising out of the performance of this study for their own instruction, research or publication without the prior express written consent of Sponsor.

Results Point of Contact

• Name/Title: Vice President, Late Stage Development Group Leader
• Organization: Merck Sharp & Dohme Corp
• Phone: 1-800-672-6372
• EMail: ClinicalTrialsDisclosure@merck.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9. doi: 10.1167/iovs.06-1413.

• Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
• ClinicalTrials.gov Identifier: NCT00105469
• Other Study ID Numbers: P08633; C-01-401-004
• First Submitted: March 14, 2005
• First Posted: March 15, 2005
• Results First Submitted: August 1, 2011
• Results First Posted: October 27, 2011
• Last Update Posted: December 16, 2013