Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment

NCT00798577 | Completed Phase 4 Results

• 1 other identifier: SMA-08-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Conjunctivitis

Keywords

Bacterial Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Exploratory Evaluation of Changes in Ocular Signs and Symptoms

  Baseline (Day 1) to Day 2

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

  24 hours after administration of first dose

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

  24 hour after administration of first dose

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

  24 hours after administration of first dose

Study Arms (2)

Vigamox

EXPERIMENTAL

Vigamox Ophthalmic Solution (Moxifloxacin 5mg/mL)

Drug: Vigamox Ophthalmic Solution

BSS Placebo

PLACEBO COMPARATOR

Balanced Salt Solution

Drug: BSS placebo

Interventions

Vigamox Ophthalmic Solution DRUG

Moxifloxacin 5mg/mL 3 times daily for 7 days

Vigamox

BSS placebo DRUG

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

BSS Placebo

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead
• Topical Solutions Ltd.: collaborator

Study Sites (1)

Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Condition Hierarchy (Ancestors)

Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Results Point of Contact

• Title: Alcon Clinical
• Organization: Alcon Labs

medinfo@alconlabs.com

1.888.451.3937; 817.568.6725

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: November 26, 2008
• Study Start: October 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: March 31, 2010
• Results First Posted: March 31, 2010

Record last verified: 2010-03

Locations

US (1)