Trial Outcomes & Findings for Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora (NCT NCT00312338)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

137 participants

Primary outcome timeframe

Day 0 and Day 42

Results posted on

2012-11-02

Participant Flow

Study recruitment started in June 2006 and ran until January 29 2008. The study sites included three sites (AZ, CA and IL)

No specific pre-assignment activities.

Participant milestones

Participant milestones
Measure	Infected Patients Infected Patients	Healthy Subjects Healthy Subjects
Overall Study STARTED	105	57
Overall Study COMPLETED	83	54
Overall Study NOT COMPLETED	22	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Infected Patients Infected Patients	Healthy Subjects Healthy Subjects
Overall Study Adverse Event	7	2
Overall Study Lost to Follow-up	9	1
Overall Study Withdrawal by Subject	4	0
Overall Study Subsequent infection	2	0

Baseline Characteristics

Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infected Patients n=105 Participants Infected Patients	Healthy Subjects n=57 Participants Healthy Subjects	Total n=162 Participants Total of all reporting groups
Age, Categorical <=18 years	105 Participants n=5 Participants	57 Participants n=7 Participants	162 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	28 Participants n=7 Participants	76 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	29 Participants n=7 Participants	86 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Infected Patients n=83 Participants Infected Patients	Healthy Subjects n=54 Participants Healthy Subjects
Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation Day 0	0 Percent of resistant isolates	0 Percent of resistant isolates
Susceptability Changes in Streptococcus Pneumoniae Distal to the Site of Instillation Day 42	0 Percent of resistant isolates	0 Percent of resistant isolates

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Infected Patients n=83 Participants Infected Patients	Healthy Subjects n=54 Participants Healthy Subjects
Susceptability Changes in Staphylococcus Aureus Distal to the Site of Instillation Day 0	8.3 Percent of resistant isolates	0 Percent of resistant isolates
Susceptability Changes in Staphylococcus Aureus Distal to the Site of Instillation Day 42	0 Percent of resistant isolates	0 Percent of resistant isolates

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Infected Patients n=83 Participants Infected Patients	Healthy Subjects n=54 Participants Healthy Subjects
Susceptability Changes in Haemophilus Influenzae Distal to the Site of Instillation Day 0	0 Percent of resistant isolates	0 Percent of resistant isolates
Susceptability Changes in Haemophilus Influenzae Distal to the Site of Instillation Day 42	0 Percent of resistant isolates	0 Percent of resistant isolates

Adverse Events

Infected Patients

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Healthy Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Infected Patients n=105 participants at risk Infected Patients	Healthy Subjects n=57 participants at risk Healthy Subjects
Infections and infestations Upper respiratory tract infection	5.7% 6/105 • Number of events 6 • Day 0 to Day 42	0.00% 0/57 • Day 0 to Day 42

Additional Information

Alcon Clinical

Alcon Research, Ltd.

Phone: 888.451.3937; 817.568.6725

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60