Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment

Phase 4

Completed

• Conditions: Bacterial Conjunctivitis
• Interventions: Drug: BSS placebo; Drug: Vigamox Ophthalmic Solution

• Registration Number: NCT00798577
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-11-25
• Study First Posted: 2008-11-26
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2010-03
• Results First Submitted: 2010-03-02
• Results First Submitted QC: 2010-03-30
• Last Update Submitted: 2010-03-30
• Results First Posted: 2010-03-31
• Last Update Posted: 2010-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BSS Placebo	BSS placebo	Balanced Salt Solution
Vigamox	Vigamox Ophthalmic Solution	Vigamox Ophthalmic Solution (Moxifloxacin 5mg/mL)

Primary Outcome Measures

Name	Time	Method
Exploratory Outcomes From Digital Photography	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.

Secondary Outcome Measures

Name	Time	Method
Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like	24 hour after administration of first dose	Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
Exploratory Evaluation of Changes in Ocular Signs and Symptoms	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.
Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans	24 hours after administration of first dose	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	24 hours after administration of first dose	Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1

Trial Locations

Locations (1)

Contact Alcon Call Center For Trial Locations; 🇺🇸 Fort Worth, Texas, United States