Back to resultsMoxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis
Primary Purpose
Bacterial Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%
Moxifloxacin AF Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Conjunctivitis focused on measuring pink eye, conjunctivitis, moxifloxacin, fluoroquinolone
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with bacterial conjunctivitis in 1 or both eyes;
- Able to understand and sign an informed consent form. If subject is <18 years of age, the informed consent must be understood and signed by the subject's legally authorized representative;
- Agrees to comply with the visit schedule and other requirements of the study;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Day 1;
- Presence of concomitant viral infection;
- Infants with ophthalmia neonatorum of gonococcal, Chlamydia, herpetic or chemical origin;
- Infants whose birth mothers had any sexually transmitted disease within 1 month prior to delivery;
- Infants undergoing treatment for retinopathy of prematurity;
- Contact lens wear during the course of the study;
- Only 1 sighted eye or vision in either eye not correctable to 0.6 logMAR units (20/80) or better;
- Use of medications, as specified in the protocol;
- Any systemic or ocular disease or disorder, complicating factors or structural abnormality that could negatively affect the conduct or outcome of the study;
- Known or suspected allergy or hypersensitivity to fluoroquinolones;
- Pregnant, lactating, or of childbearing potential and not using adequate birth control to prevent pregnancy;
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Moxifloxacin AF
Vehicle
Arm Description
Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
Outcomes
Primary Outcome Measures
Clinical Cure at the Day 4 (EOT)/Exit Visit
Clinical cure was attained if the sum of the 2 cardinal ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudate) was zero (ie, normal or absent) 12-48 hours after the last dose. Clinical cure was reported as a percentage. Only one eye (study eye) contributed to the analysis.
Secondary Outcome Measures
Microbiological Success at the Day 4 (EOT)/Exit Visit
Microbiological success was attained if the pre-therapy bacterial pathogens were eradicated 12-48 hours after the last dose. Microbiological success is reported as a percentage. Only one eye (study eye) contributed to the analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00759148
Brief Title
Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (Actual)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of Moxifloxacin AF Ophthalmic Solution compared to Moxifloxacin AF Vehicle in the treatment of bacterial conjunctivitis in patients one month of age or older.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Conjunctivitis
Keywords
pink eye, conjunctivitis, moxifloxacin, fluoroquinolone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1179 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moxifloxacin AF
Arm Type
Experimental
Arm Description
Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%
Intervention Description
Eye drops
Intervention Type
Other
Intervention Name(s)
Moxifloxacin AF Vehicle
Intervention Description
Inactive ingredients used as a placebo for masking purposes
Primary Outcome Measure Information:
Title
Clinical Cure at the Day 4 (EOT)/Exit Visit
Description
Clinical cure was attained if the sum of the 2 cardinal ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudate) was zero (ie, normal or absent) 12-48 hours after the last dose. Clinical cure was reported as a percentage. Only one eye (study eye) contributed to the analysis.
Time Frame
Day 4
Secondary Outcome Measure Information:
Title
Microbiological Success at the Day 4 (EOT)/Exit Visit
Description
Microbiological success was attained if the pre-therapy bacterial pathogens were eradicated 12-48 hours after the last dose. Microbiological success is reported as a percentage. Only one eye (study eye) contributed to the analysis.
Time Frame
Day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with bacterial conjunctivitis in 1 or both eyes;
Able to understand and sign an informed consent form. If subject is <18 years of age, the informed consent must be understood and signed by the subject's legally authorized representative;
Agrees to comply with the visit schedule and other requirements of the study;
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Day 1;
Presence of concomitant viral infection;
Infants with ophthalmia neonatorum of gonococcal, Chlamydia, herpetic or chemical origin;
Infants whose birth mothers had any sexually transmitted disease within 1 month prior to delivery;
Infants undergoing treatment for retinopathy of prematurity;
Contact lens wear during the course of the study;
Only 1 sighted eye or vision in either eye not correctable to 0.6 logMAR units (20/80) or better;
Use of medications, as specified in the protocol;
Any systemic or ocular disease or disorder, complicating factors or structural abnormality that could negatively affect the conduct or outcome of the study;
Known or suspected allergy or hypersensitivity to fluoroquinolones;
Pregnant, lactating, or of childbearing potential and not using adequate birth control to prevent pregnancy;
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alcon Research, Ltd.
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21681652
Citation
Tauber S, Cupp G, Garber R, Bartell J, Vohra F, Stroman D. Microbiological efficacy of a new ophthalmic formulation of moxifloxacin dosed twice-daily for bacterial conjunctivitis. Adv Ther. 2011 Jul;28(7):566-74. doi: 10.1007/s12325-011-0037-x. Epub 2011 Jun 14.
Results Reference
derived
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Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis
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