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Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment

Primary Purpose

Bacterial Conjunctivitis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Vigamox Ophthalmic Solution

BSS placebo

About this trial

This is an interventional treatment trial for Bacterial Conjunctivitis focused on measuring Bacterial Conjunctivitis

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis in one or both eyes of bacterial conjunctivitis based on:
- symptoms less than or equal to 24 hours prior to first visit
- rating > or equal to 1 for bulbar conjunctival injection
- must have a rating > 1 for conjunctival discharge / exudate in at least one eye (the same eye as bulbar conjunctival injection ) at Visit 1, and
Must experience some matting in the affected eye(s).
1 year of age or older, of any race and either sex
Able to understand and sign an informed consent that has been approved by an Institutional Review Board; or if the subject is a minor, the informed consent must be signed and understood by the subjects legally authorized representative (parent or guardian). Assent to participate should be obtained from subjects 6 years of age or older unless not allowed by local regulation.
Must agree to comply with study visit schedule, photographs and other study requirements. If subject is a minor, the parent or guardian must agree to ensure compliance.

Exclusion Criteria:

Cannot have had bacterial conjunctivitis as reported by subject (or parent if subject is a minor) for > 24 hours.
Any current lid disease on clinical examination.
Known or suspected allergy or hypersensitivity to fluoroquinolones.
Suspected fungal, viral (e.g. Herpes simplex) or Acanthamoeba infection, based on clinical observation.
Any systemic or ocular disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study (e.g., hepatitis, acute or chronic renal insufficiency).
Use of topical ocular medications during the study period.
Antibiotics (systemic or topical) may not be used within 7 day of visit 1 or anytime after this visit for the duration of the study.
Women of childbearing potential not using reliable means of birth control.
Women who are pregnant or lactating.
Enrollment of more than one person per household at the same time.
Enrollment of the investigator or his or her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
Participation in any investigational drug or device study within 30 days of entering this study.

Sites / Locations

Contact Alcon Call Center For Trial Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vigamox

BSS Placebo

Arm Description

Vigamox Ophthalmic Solution (Moxifloxacin 5mg/mL)

Balanced Salt Solution

Outcomes

Primary Outcome Measures

Exploratory Outcomes From Digital Photography

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.

Secondary Outcome Measures

Exploratory Evaluation of Changes in Ocular Signs and Symptoms

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.

Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans

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

Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like

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

Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae

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

Full Information

NCT ID

NCT00798577

First Posted

November 25, 2008

Last Updated

March 30, 2010

Sponsor

Alcon Research

Collaborators

Topical Solutions Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00798577

Brief Title

Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Alcon Research

Collaborators

Topical Solutions Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this study is to investigate the initial antibiotic effects in the treatment of bacterial conjunctivitis symptoms in subjects one year of age and older.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacterial Conjunctivitis

Keywords

Bacterial Conjunctivitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vigamox

Arm Type

Experimental

Arm Description

Vigamox Ophthalmic Solution (Moxifloxacin 5mg/mL)

Arm Title

BSS Placebo

Arm Type

Placebo Comparator

Arm Description

Balanced Salt Solution

Intervention Type

Drug

Intervention Name(s)

Vigamox Ophthalmic Solution

Intervention Description

Moxifloxacin 5mg/mL 3 times daily for 7 days

Intervention Type

Drug

Intervention Name(s)

BSS placebo

Intervention Description

Balanced Saline Solution for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days

Primary Outcome Measure Information:

Title

Exploratory Outcomes From Digital Photography

Description

Time Frame

24 hours after administration of first dose

Secondary Outcome Measure Information:

Title

Exploratory Evaluation of Changes in Ocular Signs and Symptoms

Description

Time Frame

Baseline (Day 1) to Day 2

Title

Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans

Description

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

Time Frame

24 hours after administration of first dose

Title

Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like

Description

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

Time Frame

24 hour after administration of first dose

Title

Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae

Description

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

Time Frame

24 hours after administration of first dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis in one or both eyes of bacterial conjunctivitis based on: symptoms less than or equal to 24 hours prior to first visit rating > or equal to 1 for bulbar conjunctival injection must have a rating > 1 for conjunctival discharge / exudate in at least one eye (the same eye as bulbar conjunctival injection ) at Visit 1, and Must experience some matting in the affected eye(s). 1 year of age or older, of any race and either sex Able to understand and sign an informed consent that has been approved by an Institutional Review Board; or if the subject is a minor, the informed consent must be signed and understood by the subjects legally authorized representative (parent or guardian). Assent to participate should be obtained from subjects 6 years of age or older unless not allowed by local regulation. Must agree to comply with study visit schedule, photographs and other study requirements. If subject is a minor, the parent or guardian must agree to ensure compliance. Exclusion Criteria: Cannot have had bacterial conjunctivitis as reported by subject (or parent if subject is a minor) for > 24 hours. Any current lid disease on clinical examination. Known or suspected allergy or hypersensitivity to fluoroquinolones. Suspected fungal, viral (e.g. Herpes simplex) or Acanthamoeba infection, based on clinical observation. Any systemic or ocular disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study (e.g., hepatitis, acute or chronic renal insufficiency). Use of topical ocular medications during the study period. Antibiotics (systemic or topical) may not be used within 7 day of visit 1 or anytime after this visit for the duration of the study. Women of childbearing potential not using reliable means of birth control. Women who are pregnant or lactating. Enrollment of more than one person per household at the same time. Enrollment of the investigator or his or her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals. Participation in any investigational drug or device study within 30 days of entering this study.

Facility Information:

Facility Name

Contact Alcon Call Center For Trial Locations

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76134

Country

United States

12. IPD Sharing Statement

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Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment

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