Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis

NCT00759148 | Completed Phase 3 Results

• 1 other identifier: C-07-40
• Study Type: interventional
• Target: 1,179
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bacterial Conjunctivitis

Keywords

pink eye; conjunctivitis; moxifloxacin; fluoroquinolone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Microbiological Success at the Day 4 (EOT)/Exit Visit

  Day 4

Study Arms (2)

Moxifloxacin AF

EXPERIMENTAL

Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days

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

Vehicle

PLACEBO COMPARATOR

Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days

Other: Moxifloxacin AF Vehicle

Interventions

Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5% DRUG

Eye drops

Moxifloxacin AF

Moxifloxacin AF Vehicle OTHER

Inactive ingredients used as a placebo for masking purposes

Vehicle

Eligibility Criteria

• Age: 1 Month+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Related Publications (1)

• 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.

  PMID: 21681652 DERIVED

MeSH Terms

Conditions

Conjunctivitis, Bacterial; Conjunctivitis

Condition Hierarchy (Ancestors)

Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections; Conjunctival Diseases; Eye Diseases

Results Point of Contact

• Title: Clinical Lead
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Alcon Research, Ltd.

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: September 25, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: January 2, 2018
• Results First Posted: March 22, 2011

Record last verified: 2017-12