Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis

Bacterial Conjunctivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759148
• Other study ID #: C-07-40
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2008
• Last updated: December 5, 2017
• Start date: October 2008
• Est. completion date: March 2010

Study information

• Verified date: December 2017
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1179
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Bacterial

Intervention

Drug:
• Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%
Eye drops

Other:
• Moxifloxacin AF Vehicle
Inactive ingredients used as a placebo for masking purposes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 4
Secondary	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.	Day 4