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Trial record 57 of 76 for:    "Bacterial Infectious Disease" | "Polyestradiol phosphate"

Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment

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ClinicalTrials.gov Identifier: NCT00798577
Recruitment Status : Completed
First Posted : November 26, 2008
Results First Posted : March 31, 2010
Last Update Posted : March 31, 2010
Sponsor:
Collaborator:
Topical Solutions Ltd.
Information provided by:
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Bacterial Conjunctivitis
Interventions Drug: Vigamox Ophthalmic Solution
Drug: BSS placebo
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vigamox Placebo
Hide Arm/Group Description Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
Period Title: Overall Study
Started 17 7
Completed 17 7
Not Completed 0 0
Arm/Group Title Vigamox Placebo Total
Hide Arm/Group Description Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days Total of all reporting groups
Overall Number of Baseline Participants 17 7 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 7 participants 24 participants
<=18 years
7
  41.2%
7
 100.0%
14
  58.3%
Between 18 and 65 years
10
  58.8%
0
   0.0%
10
  41.7%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 7 participants 24 participants
Female
11
  64.7%
5
  71.4%
16
  66.7%
Male
6
  35.3%
2
  28.6%
8
  33.3%
1.Primary Outcome
Title Exploratory Outcomes From Digital Photography
Hide Description 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.
Time Frame 24 hours after administration of first dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vigamox Placebo
Hide Arm/Group Description:
Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
Overall Number of Participants Analyzed 17 7
Measure Type: Number
Unit of Measure: Participants
17 7
2.Secondary Outcome
Title Exploratory Evaluation of Changes in Ocular Signs and Symptoms
Hide Description

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.

Time Frame Baseline (Day 1) to Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vigamox Placebo
Hide Arm/Group Description:
Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
Overall Number of Participants Analyzed 17 7
Measure Type: Number
Unit of Measure: Participants
17 7
3.Secondary Outcome
Title Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans
Hide Description Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
Time Frame 24 hours after administration of first dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vigamox Placebo
Hide Arm/Group Description:
Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
Overall Number of Participants Analyzed 17 7
Measure Type: Number
Unit of Measure: Percent bacteria eradicated
Enterobacter faecalis 17 100
Candida albicans 75 0
4.Secondary Outcome
Title Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like
Hide Description Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
Time Frame 24 hour after administration of first dose
Hide Outcome Measure Data
Hide Analysis Population Description
No patients in the Placebo group had Corynform-like bacteria (or other types of bacteria) identified at Day 1
Arm/Group Title Vigamox Placebo
Hide Arm/Group Description:
Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
Overall Number of Participants Analyzed 17 0
Measure Type: Number
Unit of Measure: Percent bacteria eradicated
Eradication of all other isolates 100
Corynform-like 0
5.Secondary Outcome
Title Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae
Hide Description Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
Time Frame 24 hours after administration of first dose
Hide Outcome Measure Data
Hide Analysis Population Description
No patients in the Vigamox group had Staphylococcus aureus, Steptococcus pneumoniae, or Enterobacter cloacae identified at Day 1.
Arm/Group Title Vigamox Placebo
Hide Arm/Group Description:
Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
Overall Number of Participants Analyzed 0 7
Measure Type: Number
Unit of Measure: Percent bacteria eradicated
Staphylococcus Aureus 0
Steptococcus Pneumoniae 50
Enterobacter Cloacae 67
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vigamox Placebo
Hide Arm/Group Description Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
All-Cause Mortality
Vigamox Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vigamox Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vigamox Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/7 (0.00%) 
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.
All presentations/publications of study results are subject to Alcon approval.
Results Point of Contact
Name/Title: Alcon Clinical
Organization: Alcon Labs
Phone: 1.888.451.3937; 817.568.6725
Responsible Party: Paul Cockrum, PhD, Director - Medical Affairs, Alcon Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00798577     History of Changes
Other Study ID Numbers: SMA-08-03
First Submitted: November 25, 2008
First Posted: November 26, 2008
Results First Submitted: March 2, 2010
Results First Posted: March 31, 2010
Last Update Posted: March 31, 2010