Status:
COMPLETED
Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis
Lead Sponsor:
Alcon Research
Conditions:
Bacterial Conjunctivitis
Eligibility:
All Genders
1+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
1179 Patients enrolled
Trial Details
Trial ID
NCT00759148
Start Date
October 1 2008
End Date
March 1 2010
Last Update
January 2 2018
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