Phase 3
N=1,179
Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis
Bacterial Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT00759148 ↗Enrolled (actual)
1,179
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Clinical Cure at the Day 4 (EOT)/Exit Visit — 62.5; 50.6 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5% (Drug); Moxifloxacin AF Vehicle (Other)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Cure at the Day 4 (EOT)/Exit Visit |
62.5; 50.6 | — |
| SECONDARY Microbiological Success at the Day 4 (EOT)/Exit Visit |
74.5; 56 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00759148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.