An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% ((VIGAMOX®) Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients

NCT01573910 | Completed Phase 3 Results DMC

• 1 other identifier: C-10-051
• Study Type: interventional
• Target: 985
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate Moxifloxacin 0.5% relative to Ofloxacin 0.3% in the treatment of bacterial conjunctivitis in Chinese patients.

Conditions

Bacterial Conjunctivitis

Keywords

Bacterial conjunctivitis; Anti-infective; Antibiotics

Outcome Measures

Primary Outcomes (2)

• Clinical Cure Rate

  Ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) were rated by the investigator on a 4-point scale, with 0=normal/absent; 1=mild; 2=moderate, and 3=severe. Clinical cure rate is presented as the percentage of participants for which the sum of the numerical scores for the 2 cardinal ocular signs of bacterial conjunctivitis was 0 at Day 9 TOC/Exit Visit.

  Day 9

• Microbiological Success Rate

  Microbiological specimen(s) from the affected eye(s) were collected according to a protocol-defined process. Microbiological success rate is presented as the percentage of participants for which the pre-therapy pathogens at Visit 1 (Day 1) were eradicated at Day 9 TOC/Exit Visit.

  Day 9

Study Arms (2)

Moxifloxacin

EXPERIMENTAL

Moxifloxacin ophthalmic solution, 0.5%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9

Drug: Moxifloxacin ophthalmic solution, 0.5%

Ofloxacin

ACTIVE COMPARATOR

Ofloxacin ophthalmic solution, 0.3%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9

Drug: Ofloxacin ophthalmic solution, 0.3%

Interventions

Moxifloxacin ophthalmic solution, 0.5% DRUG

Also known as: VIGAMOX®

Moxifloxacin

Ofloxacin ophthalmic solution, 0.3% DRUG

Also known as: Tarivid® Eye Drops

Ofloxacin

Eligibility Criteria

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

You may qualify if:

• Chinese.
• Diagnosis of bacterial conjunctivitis based on clinical observation.
• Understand and sign the approved informed consent. Legally authorized representative can provide informed consent for patients less than 18 years old and/or incapable of understanding the informed consent.
• Willing to complete all required study procedures and visits.

You may not qualify if:

• Women who are pregnant, lactating, or planning a pregnancy.
• Only 1 sighted eye or vision not correctable to 0.6 logMAR or better in either eye.
• Planned contact lens wear during the course of the study.
• Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Screening (Day 1).
• Suspected fungal, viral, or Acanthamoeba infection.
• Any systemic or ocular disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study.
• History of recent surgery.
• Presence of concomitant systemic viral infection.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Alcon (China) Ophthalmic Product Co., Ltd.

Beijing, China

Location

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Firoz Vohra, Project Head, Pharma
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Helen Yu, Lead CSM

  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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2012
• First Posted: April 10, 2012
• Study Start: May 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 12, 2015
• Results First Posted: May 12, 2015

Record last verified: 2015-04

Locations

CN (1)