Trial Outcomes & Findings for Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment (NCT NCT00798577)

Results Overview

Photographs were taken before and after treatment. Outcome is the number of patients whose photographs showed a subjective visual change based upon an exploratory review of patient photographs in signs of bacterial conjunctivitis before and after treatment.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

24 participants

Primary outcome timeframe

24 hours after administration of first dose

Results posted on

2010-03-31

Participant Flow

Participant milestones

Participant milestones
Measure	Vigamox Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days	Placebo Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
Overall Study STARTED	17	7
Overall Study COMPLETED	17	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vigamox n=17 Participants Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days	Placebo n=7 Participants Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	0 Participants n=7 Participants	10 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	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours after administration of first dose

Photographs were taken before and after treatment. Outcome is the number of patients whose photographs showed a subjective visual change based upon an exploratory review of patient photographs in signs of bacterial conjunctivitis before and after treatment.

Outcome measures

Outcome measures
Measure	Vigamox n=17 Participants Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days	Placebo n=7 Participants Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
Exploratory Outcomes From Digital Photography	17 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) to Day 2

Number of patients who had clinical resolution (0 on all scales below) from baseline (Day 1) to Day 2 in ocular and symptoms of bacterial conjunctivitis: Bulbar Conjunctival Injection - 0 (none) to 4 (Severe) scale. Conjunctival Discharge (Mucopurulent) - 0 (none) to 3 (Severe) scale. Lid Erythema - 0 (none) to 3 (Severe) scale. Lid Swelling - 0 (none) to 3 (Severe) scale. Palpebral Conjunctiva - 0 (none) to 3 (Severe) scale. Foreign Body Sensation - 0 (none) to 3 (Severe) scale. Tearing - 0 (none) to 3 (Severe) scale. Photophobia - 0 (none) to 3 (Severe) scale.

Outcome measures

Outcome measures
Measure	Vigamox n=17 Participants Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days	Placebo n=7 Participants Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
Exploratory Evaluation of Changes in Ocular Signs and Symptoms	17 Participants	7 Participants

SECONDARY outcome

Timeframe: 24 hours after administration of first dose

Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1

Outcome measures

Outcome measures
Measure	Vigamox n=17 Participants Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days	Placebo n=7 Participants Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans Enterobacter faecalis	17 Percent bacteria eradicated	100 Percent bacteria eradicated
Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans Candida albicans	75 Percent bacteria eradicated	0 Percent bacteria eradicated

SECONDARY outcome

Timeframe: 24 hour after administration of first dose

Population: No patients in the Placebo group had Corynform-like bacteria (or other types of bacteria) identified at Day 1

Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1

Outcome measures

Outcome measures
Measure	Vigamox n=17 Participants Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days	Placebo Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like Eradication of all other isolates	100 Percent bacteria eradicated	—
Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like Corynform-like	0 Percent bacteria eradicated	—

SECONDARY outcome

Timeframe: 24 hours after administration of first dose

Population: No patients in the Vigamox group had Staphylococcus aureus, Steptococcus pneumoniae, or Enterobacter cloacae identified at Day 1.

Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1

Outcome measures

Outcome measures
Measure	Vigamox Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days	Placebo n=7 Participants Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae Staphylococcus Aureus	—	0 Percent bacteria eradicated
Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae Steptococcus Pneumoniae	—	50 Percent bacteria eradicated
Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae Enterobacter Cloacae	—	67 Percent bacteria eradicated

Adverse Events

Vigamox

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Alcon Clinical

Alcon Labs

Phone: 1.888.451.3937; 817.568.6725

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All presentations/publications of study results are subject to Alcon approval.
Publication restrictions are in place

Restriction type: OTHER