Clinical trial NCT00798577: Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacterial Conjunctivitis
Keywords: Bacterial Conjunctivitis
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: Topical Solutions Ltd.
First posted: 2008-11-26
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Exploratory Outcomes From Digital Photography
timeFrame: 24 hours after administration of first dose
Secondary outcomes:
measure: Exploratory Evaluation of Changes in Ocular Signs and Symptoms
timeFrame: Baseline (Day 1) to Day 2
measure: Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans
timeFrame: 24 hours after administration of first dose
measure: Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like
timeFrame: 24 hour after administration of first dose
measure: Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae
timeFrame: 24 hours after administration of first dose
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center For Trial Locations
state: Texas
Study officials:
References: