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Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00798577
Recruitment Status : Completed
First Posted : November 26, 2008
Results First Posted : March 31, 2010
Last Update Posted : March 31, 2010
Topical Solutions Ltd.
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Bacterial Conjunctivitis Drug: Vigamox Ophthalmic Solution Drug: BSS placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

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

Primary Outcome Measures :
  1. Exploratory Outcomes From Digital Photography [ Time Frame: 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 :
  1. Exploratory Evaluation of Changes in Ocular Signs and Symptoms [ Time Frame: 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.

  2. Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans [ Time Frame: 24 hours after administration of first dose ]
    Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1

  3. Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like [ Time Frame: 24 hour after administration of first dose ]
    Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1

  4. Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae [ Time Frame: 24 hours after administration of first dose ]
    Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00798577

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United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Topical Solutions Ltd.

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Responsible Party: Paul Cockrum, PhD, Director - Medical Affairs, Alcon Laboratories, Inc. Identifier: NCT00798577     History of Changes
Other Study ID Numbers: SMA-08-03
First Posted: November 26, 2008    Key Record Dates
Results First Posted: March 31, 2010
Last Update Posted: March 31, 2010
Last Verified: March 2010
Keywords provided by Alcon Research:
Bacterial Conjunctivitis
Additional relevant MeSH terms:
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Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Ophthalmic Solutions
Norgestimate, ethinyl estradiol drug combination
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs