Clinical Trial Results:
Open-labeled, randomized, comparative clinical study of efficacy and safety of Levofloxan 0,5% eye drops in patients with Acute Bacterial Conjunctivitis.
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Summary
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EudraCT number |
2012-003664-41 |
Trial protocol |
BG |
Global end of trial date |
27 Jun 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
11 Feb 2020
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First version publication date |
11 Feb 2020
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
PMS/LEVO-001-06-2012
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Balkanpharma-Razgrad AD
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Sponsor organisation address |
68 “Aprilsko vastanie” Blvd. , Razgrad, Bulgaria,
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Public contact |
Research and Development, Balkanpharma-Razgrad AD, +359 84613303, office@razgrad.bg
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Scientific contact |
Research and Development, Balkanpharma-Razgrad AD, +359 84613303, office@razgrad.bg
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Jun 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Jun 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Jun 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
- Evaluation of therapeutically effect of Levofloxan 0,5% eye drops in patients with Acute Bacterial Conjunctivitis.
- Comparative evaluation of efficacy of Levofloxan 0,5% eye drops with respect to the comparator
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Protection of trial subjects |
Prior to the start of the study, the study protocol, the informed consent and assent documents, patient instruction sheets, as well as any advertising materials used to recruit patients were submitted to Bulgarian Drug Agency (BDA) and ethics committees for mulricenter trials (ECMT). The BDA/ECMTs reviewed all documents and approved required documents. Consistent with both the BDA/ECMT's requirements and all applicable regulations, the Investigators periodically provided study updates to the BDA/ECMT's . A patient provided informed consent, and children signed an approved assent form when appropriate. This study was conducted in accordance with Good Clinical Practices (GCP) and the ethical principles that have their origins in the Declaration of Helsinki.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
26 Jul 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Bulgaria: 70
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Worldwide total number of subjects |
70
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EEA total number of subjects |
70
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
61
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From 65 to 84 years |
9
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were recruited from 2 study centers located in Bulgaria. | |||||||||||||||
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Pre-assignment
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Screening details |
70 subjects with bacterial conjunctivitis were randomized and treated with Levofloxan eye drops or Oftaquix eye drops. | |||||||||||||||
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Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Blinding implementation details |
The study was conducted as open with regard to the IMPs. In the Information for the patient, detailed information was provided in accessible language on the investigational medicinal products, the usual dosage and method of administration. The manufacturer of the medicine was specified.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Levofloxan | |||||||||||||||
Arm description |
Levofloxan 0.5% eye drops, solution | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Levofloxan 0.5% eye drops
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Investigational medicinal product code |
A
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Other name |
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Pharmaceutical forms |
Eye drops, solution
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Routes of administration |
Ophthalmic use
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Dosage and administration details |
Days 1-2: 1-2 drops every 2 (two) hours in the affected eye/eyes
Days 3-7: 1-2 drops 4 times daily in the affected eye/eyes
Average duration of treatment: 5 days.
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Arm title
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Oftaquix | |||||||||||||||
Arm description |
Oftaquix 0.5% eye drops, solution | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Oftaquix 0.5% eye drops
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Investigational medicinal product code |
B
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Other name |
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Pharmaceutical forms |
Eye drops, solution
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Routes of administration |
Ophthalmic use
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Dosage and administration details |
Days 1-2: 1-2 drops every 2 (two) hours in the affected eye/eyes
Days 3-7: 1-2 drops 4 times daily in the affected eye/eyes
Average duration of treatment: 5 days.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Levofloxan
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Subject analysis set type |
Sub-group analysis | |||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Levofloxan 0.5% eye drops
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Subject analysis set title |
Oftaquix
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Subject analysis set type |
Sub-group analysis | |||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Oftaquix 0.5% eye drops
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End points reporting groups
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Reporting group title |
Levofloxan
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Reporting group description |
Levofloxan 0.5% eye drops, solution | ||
Reporting group title |
Oftaquix
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Reporting group description |
Oftaquix 0.5% eye drops, solution | ||
Subject analysis set title |
Levofloxan
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Levofloxan 0.5% eye drops
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Subject analysis set title |
Oftaquix
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Oftaquix 0.5% eye drops
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End point title |
Evaluation of therapeutical effect of Levofloxan 0,5% eye drops in patients with Acute Bacterial Conjunctivitis | |||||||||
End point description |
Evaluation of therapeutic effect of Levofloxan 0,5% eye drops in patients with Acute Bacterial Conjunctivitis.
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End point type |
Primary
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End point timeframe |
Visit 1, Visit 2 and Visit 3
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Statistical analysis title |
Therapeutic effect - Ocular signs and symptoms | |||||||||
Statistical analysis description |
Therapeutic results after both treatments on the Ocular signs and symptoms - Ocular signs and symptoms (anamnestic data).
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Comparison groups |
Oftaquix v Levofloxan
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Number of subjects included in analysis |
62
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Analysis specification |
Pre-specified
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Analysis type |
superiority [1] | |||||||||
P-value |
= 0.05 | |||||||||
Method |
Fisher exact | |||||||||
Parameter type |
Chi-square = 0.344; р-value =0.755 | |||||||||
Confidence interval |
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| Notes [1] - Main clinical parameters were measured, compared and assessed. Evaluation of clinical signs and symptoms, such as photosensitivity, pain, burning, itching, irritation and eyelid sticking were carried out according to a preliminary prepared scale. |
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Statistical analysis title |
Therapeutic effect - Microbiological examination | |||||||||
Statistical analysis description |
Evaluation of main clinical parameter - microbiological findings.
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Comparison groups |
Levofloxan v Oftaquix
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Number of subjects included in analysis |
62
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Analysis specification |
Pre-specified
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Analysis type |
superiority [2] | |||||||||
P-value |
= 0.05 | |||||||||
Method |
Fisher exact | |||||||||
Parameter type |
Chi-square = 2.542; p-value=0.155 | |||||||||
Confidence interval |
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| Notes [2] - Main clinical parameter microbiological findings was measured, compared and assessed. |
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Statistical analysis title |
Therapeutic effect - Clinical examination | |||||||||
Statistical analysis description |
Clinical examination.
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Comparison groups |
Levofloxan v Oftaquix
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Number of subjects included in analysis |
62
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.05 | |||||||||
Method |
Fisher exact | |||||||||
Parameter type |
Chi-square = 0.000; p-value=1.00 | |||||||||
Confidence interval |
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End point title |
Comparative evaluation of efficacy of Levofloxan 0,5% eye drops with respect to the comparator | |||||||||
End point description |
In order to assess the therapeutic equivalence, the following primary end-points were evaluated and compared:
microbiological findings, rate of eradication of the causative agent and data of biomicroscopy.
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End point type |
Primary
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End point timeframe |
Visit 1, Visit 2, Visit 3
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Statistical analysis title |
Microbiological findings and rate of eradication | |||||||||
Statistical analysis description |
A microbiological examinations were provided aimed at isolating the bacterial cause, determining its susceptibility to levofloxacin and assessing the degree of eradication.
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Comparison groups |
Levofloxan v Oftaquix
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Number of subjects included in analysis |
62
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.05 | |||||||||
Method |
Fisher exact | |||||||||
Parameter type |
Chi-square = 2.542; р-value =0.155 | |||||||||
Confidence interval |
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Statistical analysis title |
Biomicroscopical exam. - Conjunctival discharge A | |||||||||
Statistical analysis description |
Biomicroscopical examination results for Conjunctival discharge after application of Levofloxan 0.5% eye drops.
Mean and 95% confidence intervals refer to the percent of remaining without significant improvement volunteers at the last (3-rd) visit.
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Comparison groups |
Levofloxan v Oftaquix
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Number of subjects included in analysis |
62
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.05 | |||||||||
Method |
ANCOVA | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
0.03
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0 | |||||||||
upper limit |
0.09 | |||||||||
Statistical analysis title |
Biomicroscopical exam. - Conjunctival discharge B | |||||||||
Statistical analysis description |
Biomicroscopical examination results for Conjunctival discharge afrer application of Oftaquix 0.5% eye drops.
Mean and 95% confidence intervals refer to the percent of remaining without significant improvement volunteers at the last (3-rd) visit.
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Comparison groups |
Levofloxan v Oftaquix
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Number of subjects included in analysis |
62
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.05 | |||||||||
Method |
ANCOVA | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
0.14
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0 | |||||||||
upper limit |
0.32 | |||||||||
Statistical analysis title |
Biomicrosc exam. - Bulbar conjunctival injection A | |||||||||
Statistical analysis description |
Biomicroscopical examination results for Bulbar conjunctival injection after application of Levofloxan 0.5% eye drops.
Mean and 95% confidence intervals refer to the percent of remaining without significant improvement volunteers at the last (3-rd) visit.
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Comparison groups |
Oftaquix v Levofloxan
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Number of subjects included in analysis |
62
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.05 | |||||||||
Method |
ANCOVA | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
0.06
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0 | |||||||||
upper limit |
0.15 | |||||||||
Statistical analysis title |
Biomicrosc exam. - Bulbar conjunctival injection B | |||||||||
Statistical analysis description |
Biomicroscopical examination results for Bulbar conjunctival injection after application of Oftaquix 0.5% eye drops.
Mean and 95% confidence intervals refer to the percent of remaining without significant improvement volunteers at the last (3-rd) visit.
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Comparison groups |
Levofloxan v Oftaquix
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Number of subjects included in analysis |
62
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.05 | |||||||||
Method |
ANCOVA | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
0.18
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0 | |||||||||
upper limit |
0.39 | |||||||||
Statistical analysis title |
Biomicr. exam. Palpebral conjunctival injection A | |||||||||
Statistical analysis description |
Biomicroscopical examination results for Palpebral conjunctival injection after application of Levofloxan 0.5% eye drops.
Mean and 95% confidence intervals refer to the percent of remaining without significant improvement volunteers at the last (3-rd) visit.
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Comparison groups |
Levofloxan v Oftaquix
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Number of subjects included in analysis |
62
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.05 | |||||||||
Method |
ANCOVA | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
0.03
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0 | |||||||||
upper limit |
0.09 | |||||||||
Statistical analysis title |
Biomicr. exam. Palpebral conjunctival injection B | |||||||||
Statistical analysis description |
Biomicroscopical examination results for Palpebral conjunctival injection after application of Oftaquix 0.5% eye drops.
Mean and 95% confidence intervals refer to the percent of remaining without significant improvement volunteers at the last (3-rd) visit.
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Comparison groups |
Levofloxan v Oftaquix
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Number of subjects included in analysis |
62
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.05 | |||||||||
Method |
ANCOVA | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
0.18
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0 | |||||||||
upper limit |
0.39 | |||||||||
Statistical analysis title |
Comparative evaluation of efficacy - Clinical exam | |||||||||
Statistical analysis description |
Comparative evaluation of efficacy of Levofloxan 0.5% eye drops with respect to the comparator - clinical examination
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Comparison groups |
Levofloxan v Oftaquix
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Number of subjects included in analysis |
62
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.05 | |||||||||
Method |
Fisher exact | |||||||||
Parameter type |
Chi-square = 0.000; р-value =1.00 | |||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Adverse events are collected from First Patient First Visit until Last Patient Last Visit.
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Assessment type |
Systematic | |||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||
Dictionary version |
16.0
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Reporting groups
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Reporting group title |
Levofloxan eye drops, solution
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Reporting group description |
- | |||||||||||||||
Reporting group title |
Oftaquix eye drops, solution
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Reporting group description |
- | |||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||
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| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Throughout the study, none of the participants reported an adverse event. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
