Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Conjunctivitis
• Intervention / Treatment: Drug: Vigamox Ophthalmic Solution; Drug: BSS placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vigamox; Vigamox Ophthalmic Solution (Moxifloxacin 5mg/mL)	Drug: Vigamox Ophthalmic Solution; Moxifloxacin 5mg/mL 3 times daily for 7 days
Placebo Comparator: BSS Placebo; Balanced Salt Solution	Drug: BSS placebo; Balanced Saline Solution for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours after administration of first dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day 1) to Day 2
Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans	Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1	24 hours after administration of first dose
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	24 hour after administration of first dose
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	24 hours after administration of first dose

Collaborators and Investigators

• Sponsor: Alcon Research
• Collaborators: Topical Solutions Ltd.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: November 25, 2008
• First Submitted That Met QC Criteria: November 25, 2008
• First Posted (Estimate): November 26, 2008

Study Record Updates

• Last Update Posted (Estimate): March 31, 2010
• Last Update Submitted That Met QC Criteria: March 30, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Bacterial Conjunctivitis
• Additional Relevant MeSH Terms: Infections; Eye Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Conjunctival Diseases; Eye Infections, Bacterial; Eye Infections; Conjunctivitis; Conjunctivitis, Bacterial; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: SMA-08-03