Bacterial ConjunctivitisPhase 2/3NCT00565123
Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial Conjunctivitis
A Phase 2/3 study testing 0.5% levofloxacin eye drops in people with Bacterial Conjunctivitis, run by Laser Microsurgery Centre, Poland at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bacterial Conjunctivitis
- What is being tested?
- 0.5% levofloxacin eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2004to Jan 2006
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Centrum Mikrochirurgii Oka Laser
Warsaw, Masovian Voivodeship, 00-131
About this study
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
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.
- Conditions
- Bacterial Conjunctivitis
- Being tested
- 0.5% levofloxacin eye drops
- Keywords
- bacterial conjunctivitis levofloxacin fluoroquinolone
- Medical subject headings
- Conjunctivitis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% levofloxacin eye dropsDrug
0.5% levofloxacin eye drops three times daily to each eye for 5 days
0.5% levofloxacin eye dropsDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Experimental dosage Receives: Drug: 0.5% levofloxacin eye drops |
| Group B | Active comparator | Classical dosage Receives: Drug: 0.5% levofloxacin eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint was the clinical cure.
Measured: 7(+-1) days
Secondary outcomes (1)
The secondary efficacy end point was the microbiological eradication.
Measured: 7(+-1) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2007 (estimated)
- Study startSep 2004
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laser Microsurgery Centre, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Katedra I Klinika Okulistyki II Wydz. Lek. AM w Warszawie,, University Hospital No 1 Wroclaw, MedSource Polska
- Investigators
- Jerzy Szaflik, MD,Ph.D., Principal investigator, Laser Microsurgery Centre; Department of Ophthalmology, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565123
- Sponsor's protocol ID
- LF- 12/2003
- Status last verified
- Nov 2007
- First submitted
- 27 Nov 2007
- Last updated
- 29 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00565123
- Acronym / sponsor ID
- LF- 12/2003
- Conditions
- Bacterial Conjunctivitis
- Keywords
- bacterial conjunctivitis levofloxacin fluoroquinolone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Laser Microsurgery Centre, PolandUniversity, hospital or other
- Collaborators
- Katedra I Klinika Okulistyki II Wydz. Lek. AM w Warszawie,, University Hospital No 1 Wroclaw, MedSource Polska
- Study start
- Sep 2004
- Study completion
- Jan 2006 (actual)
- First posted
- 29 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: 0.5% levofloxacin eye dropsExperimental dosage |
| Group B | Active comparator | Drug: 0.5% levofloxacin eye dropsClassical dosage |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- Insulin Dependent Diabetes Mellitus (IDDM)
- Patients with keratitis or hordeolum
- Glaucoma
- Sjogren's Syndrom and "Sick Eye's Syndrom".
- Ectropion, entropion;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5% levofloxacin eye drops0.5% levofloxacin eye drops three times daily to each eye for 5 days | Drug | Group A |
| 0.5% levofloxacin eye drops0.5% 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) | Drug | Group B |
Primary outcome
The primary efficacy endpoint was the clinical cure.
Time frame: 7(+-1) days
1 secondary outcome
The secondary efficacy end point was the microbiological eradication.
Time frame: 7(+-1) days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerzy Szaflik, MD,Ph.D. principal investigator
Laser Microsurgery Centre; Department of Ophthalmology, Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 0.5% levofloxacin eye drops in people with Bacterial Conjunctivitis, run by Laser Microsurgery Centre, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy endpoint was the clinical cure. (time frame: 7(+-1) days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2007.