Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial Conjunctivitis
Primary Purpose
Bacterial Conjunctivitis
Status
Completed
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
0.5% levofloxacin eye drops
0.5% levofloxacin eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Conjunctivitis focused on measuring bacterial conjunctivitis levofloxacin fluoroquinolone
Eligibility Criteria
Inclusion Criteria:
- Male and female patients between 18 and 70 years of age
- Patients with Conjunctivitis (defined as the presence of three cardinal signs: conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection)
- Patients who have given and signed informed consent
- The ability and willingness to comply with all study procedures
Exclusion Criteria:
- Insulin Dependent Diabetes Mellitus (IDDM)
- Patients with keratitis or hordeolum
- Glaucoma
- Sjogren's Syndrom and "Sick Eye's Syndrom".
- Ectropion, entropion;
- Using contact lenses during the study
- Poor visual acuity in the other eye
- Prior and concurrent concomitant treatment glycocorticosteroids, immunosupressive therapy, if these treatments have not stopped at least 3 months prior to the start of the study;
- Concurrent use of non- steriodal anti- inflammatory drugs (NSAIDs), with the exception of low- dose aspirin. (see par. 11.5)
- Prior and concurrent systemic antibiotic treatment during last 7 days before the beginning the study.(see par. 11.5)
- Concurrent other eye drops
- All ocular surgeries which were performed less than 6 months before the beginning of the study.
- Any clinical condition, which, in the opinion of the investigator would not allow safe completion of the protocol.
- History of any malignancy within the past 5 years prior to study entry, except basal cell or squamous cell skin carcinoma.
- Hypersensitivity to fluoroquinolons and benzalkonium chloride;
- Intended or ascertained pregnancy or lactation;
- Participation in a clinical trial within last 30 days.
Sites / Locations
- Centrum Mikrochirurgii Oka Laser
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
Experimental dosage
Classical dosage
Outcomes
Primary Outcome Measures
The primary efficacy endpoint was the clinical cure.
Secondary Outcome Measures
The secondary efficacy end point was the microbiological eradication.
Full Information
NCT ID
NCT00565123
First Posted
November 27, 2007
Last Updated
November 28, 2007
Sponsor
Laser Microsurgery Centre, Poland
Collaborators
Katedra I Klinika Okulistyki II Wydz. Lek. AM w Warszawie,, University Hospital No 1 Wroclaw, MedSource Polska
1. Study Identification
Unique Protocol Identification Number
NCT00565123
Brief Title
Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial Conjunctivitis
Official Title
A Single- Centre, Randomised Study Of The Clinical And Microbiological Efficacy Of Decreasing The Dosage Of Levofloxacin 0,5% Eye Drops As Compared To Standard Eye Drop Dosage In Patients With Bacterial Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Laser Microsurgery Centre, Poland
Collaborators
Katedra I Klinika Okulistyki II Wydz. Lek. AM w Warszawie,, University Hospital No 1 Wroclaw, MedSource Polska
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to evaluate the clinical and microbiological efficacies of three times daily administration of levofloxacin 0,5% eye drops as compared to the more frequent dosing (up to 8 times a day during the first 2 days and up to 4 times a day during the next 3 days) in patients with bacterial conjunctivitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Conjunctivitis
Keywords
bacterial conjunctivitis levofloxacin fluoroquinolone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Experimental dosage
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Classical dosage
Intervention Type
Drug
Intervention Name(s)
0.5% levofloxacin eye drops
Intervention Description
0.5% levofloxacin eye drops three times daily to each eye for 5 days
Intervention Type
Drug
Intervention Name(s)
0.5% levofloxacin eye drops
Intervention Description
0.5% levofloxacin eye drops 2 hours on days 1 and 2, and then every 4 hours on days 3-5 (up to 4 times per day)
Primary Outcome Measure Information:
Title
The primary efficacy endpoint was the clinical cure.
Time Frame
7(+-1) days
Secondary Outcome Measure Information:
Title
The secondary efficacy end point was the microbiological eradication.
Time Frame
7(+-1) days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patients between 18 and 70 years of age
Patients with Conjunctivitis (defined as the presence of three cardinal signs: conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection)
Patients who have given and signed informed consent
The ability and willingness to comply with all study procedures
Exclusion Criteria:
Insulin Dependent Diabetes Mellitus (IDDM)
Patients with keratitis or hordeolum
Glaucoma
Sjogren's Syndrom and "Sick Eye's Syndrom".
Ectropion, entropion;
Using contact lenses during the study
Poor visual acuity in the other eye
Prior and concurrent concomitant treatment glycocorticosteroids, immunosupressive therapy, if these treatments have not stopped at least 3 months prior to the start of the study;
Concurrent use of non- steriodal anti- inflammatory drugs (NSAIDs), with the exception of low- dose aspirin. (see par. 11.5)
Prior and concurrent systemic antibiotic treatment during last 7 days before the beginning the study.(see par. 11.5)
Concurrent other eye drops
All ocular surgeries which were performed less than 6 months before the beginning of the study.
Any clinical condition, which, in the opinion of the investigator would not allow safe completion of the protocol.
History of any malignancy within the past 5 years prior to study entry, except basal cell or squamous cell skin carcinoma.
Hypersensitivity to fluoroquinolons and benzalkonium chloride;
Intended or ascertained pregnancy or lactation;
Participation in a clinical trial within last 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerzy Szaflik, MD,Ph.D.
Organizational Affiliation
Laser Microsurgery Centre; Department of Ophthalmology, Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centrum Mikrochirurgii Oka Laser
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-131
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial Conjunctivitis
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