An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients
This study is currently recruiting participants.
Verified April 2013 by Alcon Research
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01573910
First received: April 6, 2012
Last updated: April 25, 2013
Last verified: April 2013
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Purpose
The purpose of this study is to demonstrate non-inferiority of Moxifloxacin 0.5% relative to Ofloxacin 0.3% in the treatment of bacterial conjunctivitis in Chinese patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Bacterial Conjunctivitis |
Drug: Moxifloxacin Ophthalmic Solution, 0.5% Drug: Ofloxacin Ophthalmic Solution, 0.3% |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
Resource links provided by NLM:
MedlinePlus related topics:
Pinkeye
Drug Information available for:
Ofloxacin
Levofloxacin
Ofloxacin hydrochloride
Moxifloxacin
Moxifloxacin hydrochloride
U.S. FDA Resources
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Clinical Cure Rate [ Time Frame: Day 9 ] [ Designated as safety issue: No ]The investigator will rate the ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) in each eye of the patient. Bulbar conjunctival injection and conjunctival discharge/exudates will be rated on a 4-point scale ranging from 0 to 3, with 0 = normal/absent; 1 = mild; 2 = moderate, and 3 = severe. Clinical cure will be considered attained if the sum of the ocular signs of bacterial conjunctivitis is 0.
- Microbiological Success Rate [ Time Frame: Day 9 ] [ Designated as safety issue: No ]Microbiological specimen(s) from the patient's affected eye(s) will be collected according to a protocol-defined process. Microbiological success will be considered attained if the pre-therapy pathogens are eradicated.
| Estimated Enrollment: | 434 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Moxifloxacin
One drop three times per day (TID) in both eyes for seven days, with a test-of-cure (TOC) at Day 9.
|
Drug: Moxifloxacin Ophthalmic Solution, 0.5%
Topical ocular solution. One drop instilled into the conjunctival sac of both eyes three times daily for seven days.
|
|
Active Comparator: Ofloxacin
One drop three times per day (TID) in both eyes for seven days, with a test-of-cure (TOC) at Day 9.
|
Drug: Ofloxacin Ophthalmic Solution, 0.3%
Topical ocular solution. One drop instilled into the conjunctival sac of both eyes three times daily for seven days.
|
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Be at least one year of age (of either sex and of Chinese race).
Diagnosis of bacterial conjunctivitis based on clinical observation.
- Rating ≥1 for bulbar conjunctival injection and ≥1 for conjunctival discharge/exudate in at least one eye (the same eye) and;
- Matting in the affected eye(s).
- Understand and sign the approved Informed Consent. Legally authorized representative can provide informed consent for patients under 18 years old and/or patients incapable of understanding the Informed Consent.
- Willing to complete all required study procedures and visits.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Pregnant or lactating women, women who have a positive urine pregnancy test, or women who are planning a pregnancy.
- Only one sighted eye or vision not correctable to 0.6 logMAR or better in either eye. Visual acuity measurement for children less than 5 years of age is to be conducted at the discretion of the investigator. If visual acuity is not measured, the child must be able to fix and follow.
- Participation in any other investigational clinical study within the previous 30 days.
- Planned contact lens wear during the course of the study.
- Presence of signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Screening (Day 1).
- Suspected fungal, viral, or Acanthamoeba infection based on clinical observation.
- Presence of active inflammation and/or active structural change in the cornea, iris, or anterior chamber at Screening.
- Known or suspected allergy or hypersensitivity to any component of the study medications.
- Use of any topical ocular medications at time of entry into the study or during study participation.
- Other protocol-defined exclusion criteria may apply.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01573910 History of Changes |
| Other Study ID Numbers: | C-10-051 |
| Study First Received: | April 6, 2012 |
| Last Updated: | April 25, 2013 |
| Health Authority: | China: Food and Drug Administration China: Ethics Committee |
Keywords provided by Alcon Research:
|
Bacterial conjunctivitis Anti-infective Antibiotics |
Additional relevant MeSH terms:
|
Eye Infections, Bacterial Eye Infections Conjunctivitis Conjunctivitis, Bacterial Conjunctival Diseases Eye Diseases Bacterial Infections Infection Ofloxacin Moxifloxacin Norgestimate, ethinyl estradiol drug combination Anti-Bacterial Agents Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013