Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00312338
• Collaborator: Tufts University (Other)
• Enrollment: 137
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 11.4

Study Details

Study Description

Brief Summary

Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora

Condition or Disease	Intervention/Treatment	Phase
Bacterial Conjunctivitis	Drug: VIGAMOX	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 137 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Official Title: Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Jun 1, 2007
• Actual Study Completion Date: Jun 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Infected Patient treated with Vigamox Conjunctivitis-Infected Patient receiving Vigamox 0.5% in both eyes three times daily for 7 days.	Drug: VIGAMOX; 1 drop of VIGAMOX® ophthalmic solution 0.5% in both eyes TID for 7 days
No Intervention: Healthy Subjects Healthy Subjects receiving no treatment

Outcome Measures

Primary Outcome Measures

1. Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation [Day 0 and Day 42]

   Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI). 0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic

2. Susceptability Changes in Staphylococcus Aureus Distal to the Site of Instillation [Day 0, Day 42]

   Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI). 0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic

3. Susceptability Changes in Haemophilus Influenzae Distal to the Site of Instillation [Day 0, Day 42]

   Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI). 0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 13 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients from 1 to 13 years of age that have diagnosis of bacterial conjunctivitis in either or both eyes (for < 3 days duration) based on clinical observation; matched healthy controls

Exclusion Criteria:

• Cannot have had bacterial conjunctivitis symptoms as reported by parent for > 2 days

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Multiple Locations	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research
• Tufts University

Investigators

• Principal Investigator: Steven J. Lichtenstein, M.D., Investigator / Contact

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00312338
• Other Study ID Numbers: CMS-05-11
• First Posted: Apr 10, 2006
• Last Update Posted: Nov 2, 2012
• Last Verified: Feb 1, 2010

• Additional relevant MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Study Results

Participant Flow

Recruitment Details	Study recruitment started in June 2006 and ran until January 29 2008. The study sites included three sites (AZ, CA and IL)
Pre-assignment Detail	No specific pre-assignment activities.

Arm/Group Title	Infected Patients	Healthy Subjects
Arm/Group Description	Infected Patients	Healthy Subjects
Period Title: Overall Study
STARTED	105	57
COMPLETED	83	54
NOT COMPLETED	22	3

Baseline Characteristics

Arm/Group Title	Infected Patients	Healthy Subjects	Total
Arm/Group Description	Infected Patients	Healthy Subjects	Total of all reporting groups
Overall Participants	105	57	162
Age (Count of Participants)
<=18 years	105 100%	57 100%	162 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	48 45.7%	28 49.1%	76 46.9%
Male	57 54.3%	29 50.9%	86 53.1%

Outcome Measures

1. Primary Outcome

Title	Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation
Description	Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI). 0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic
Time Frame	Day 0 and Day 42

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Infected Patients	Healthy Subjects
Arm/Group Description	Infected Patients	Healthy Subjects
Measure Participants	83	54
Day 0	0	0
Day 42	0	0

2. Primary Outcome

Title	Susceptability Changes in Staphylococcus Aureus Distal to the Site of Instillation
Description	Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI). 0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic
Time Frame	Day 0, Day 42

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Infected Patients	Healthy Subjects
Arm/Group Description	Infected Patients	Healthy Subjects
Measure Participants	83	54
Day 0	8.3	0
Day 42	0	0

3. Primary Outcome

Title	Susceptability Changes in Haemophilus Influenzae Distal to the Site of Instillation
Description	Susceptibility change refers to a change in vulnerability of a specified bacterial strain to antibiotic treatment. Susceptibility was assessed by broth microdilution methods recommended by the Clinical and Laboratory Standards Institute (CLSI). 0% = zero isolates were resistant to antibiotic 100% = all isolates were resistant to antibiotic
Time Frame	Day 0, Day 42

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Infected Patients	Healthy Subjects
Arm/Group Description	Infected Patients	Healthy Subjects
Measure Participants	83	54
Day 0	0	0
Day 42	0	0

Adverse Events

Time Frame	Day 0 to Day 42
Arm/Group Title	Infected Patients		Healthy Subjects
Arm/Group Description	Infected Patients		Healthy Subjects
All Cause Mortality
	Infected Patients		Healthy Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Infected Patients		Healthy Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/105 (0%)		0/57 (0%)
Other (Not Including Serious) Adverse Events
	Infected Patients		Healthy Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/105 (5.7%)		0/57 (0%)
Infections and infestations
Upper respiratory tract infection	6/105 (5.7%)	6	0/57 (0%)	0

Limitations/Caveats

Limited source documents.

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.