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Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment

NCT ID: NCT00798577

Last Updated: 2010-03-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Bacterial Conjunctivitis

Keywords

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Bacterial Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vigamox

Vigamox Ophthalmic Solution (Moxifloxacin 5mg/mL)

Group Type EXPERIMENTAL

Vigamox Ophthalmic Solution

Intervention Type DRUG

Moxifloxacin 5mg/mL 3 times daily for 7 days

BSS Placebo

Balanced Salt Solution

Group Type PLACEBO_COMPARATOR

BSS placebo

Intervention Type DRUG

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

Interventions

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Vigamox Ophthalmic Solution

Moxifloxacin 5mg/mL 3 times daily for 7 days

Intervention Type DRUG

BSS placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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
2. Must experience some matting in the affected eye(s).
3. 1 year of age or older, of any race and either sex
4. 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.
5. 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

1. Cannot have had bacterial conjunctivitis as reported by subject (or parent if subject is a minor) for \> 24 hours.
2. Any current lid disease on clinical examination.
3. Known or suspected allergy or hypersensitivity to fluoroquinolones.
4. Suspected fungal, viral (e.g. Herpes simplex) or Acanthamoeba infection, based on clinical observation.
5. 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).
6. Use of topical ocular medications during the study period.
7. 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.
8. Women of childbearing potential not using reliable means of birth control.
9. Women who are pregnant or lactating.
10. Enrollment of more than one person per household at the same time.
11. 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.
12. Participation in any investigational drug or device study within 30 days of entering this study.
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Topical Solutions Ltd.

INDUSTRY

Sponsor Role collaborator

Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Alcon Laboratories, Inc.

Locations

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Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SMA-08-03

Identifier Type: -

Identifier Source: org_study_id