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A randomized, double blind, phase II multicenter trial with the objective of assess the safety and efficacy of the PRO-157 ophthalmic solution in three different dosing regimens, versus Moxifloxacin, versus Gatifloxacin in patients with bacterial conjunctivitis.
Number of participants: 300 eyes, 60 per group.
Criteria for evaluation:
Measurements of effectiveness: Main efficacy criterion It will be determined as effective if there is a reduction in number or species of bacterial flora by comparing the basal culture against the final culture among the five different patient groups.
Reduction or absence of infection with the clinical evaluation through signs and symptoms.
Safety Measurements: it will be determined by visual acuity and adverse events Patients recruited will be treated for 7, for protocol purpose, the infected eye (s) will be taken into account at the time of baseline, however the study medication and procedures will be applied and performed in both eyes to protect the healthy eye.
The study is divided into the following evaluation periods:
Visit 1 baseline (day 1), visit 2 (day 3), final visit (day 8) and a telephone call (day 23) for the evaluation of adverse events.
Subjects will be allocated to any of the following regimen dosages:
Data Analysis: The data will be analyzed by Intention to Treat (ITT) and per Protocol (PP) in which each of the variables is described, the ITT population will be constituted by all subjects recruited who have received at least one dose of the study, the PP population will be the subset of ITT composed of all subjects without any major deviation from the protocol and the bivariate analysis will be performed in this group.
Continuous quantitative variables are expressed and presented by measures of central tendency and dispersion (mean, standard deviation and ranges). Qualitative nominal and ordinal variables are presented by means of frequencies and proportions. The level of significance was an alpha of 0.05 or less.
Lagricel Ofteno® is a registered trademark, therefore the use of the same throughout the document can not be translated into the English language.
PRO-157, the acronym is part of an internal code used to record formulations or research projects and the numbers indicate consecutive of the molecule under study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO-157 BID (2 times per day) | Experimental | 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
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| PRO-157 TID (3 times per day) | Experimental | 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
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| PRO-157 QID (4 times per day) | Experimental | 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
|
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| Moxifloxacin (Vigamox®) | Active Comparator | 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO-157 | Drug | PRO-157 (Pazufloxacin 0.06%) Laboratories Sophia S.A. de C.V., ophthalmic solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Bacterial Culture | Efficacy will be determined comparing the cultures of the lower conjunctival pouch, of the baseline (day 1) against final visit (day 8), quantifying and identifying the colony forming units (CFU) by genus and species. The evaluated variable is discrete quantitative type and the scale of measurement used will be CFU x mL considering the eradication, reduction or proliferation of the bacterial agent. It will be determined as effective if there is a reduction in number of bacterial flora in at least 95% of the evaluated subjects. | up to one week |
| Adverse Events | Number of adverse events: dependent variable, discrete quantitative, the number of adverse events per group will be compared at the end of the study and it will be considered safe if there is not greater increase of 5% of serious adverse events. | during the intervention period for 7 days, and 15 days after the final visit |
| Measure | Description | Time Frame |
|---|---|---|
| Cases Frequency of Ocular Secretion | Secretion ocular: qualitative ordinal variable. The secretion was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group. | Up to one week. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leopoldo Baiza, MD | Laboratorios Sophia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidad Medica "Grupo Pediátrico" | Guadalajara | Jalisco | 44690 | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | PRO-157 BID (2 Times Per Day) | 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution |
| FG001 | PRO-157 TID (3 Times Per Day) | 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution |
| FG002 | PRO-157 QID (4 Times Per Day) | 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution |
| FG003 | Moxifloxacin (Vigamox®) | 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution |
| FG004 | Gatifloxacin (Zymar®) | 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | PRO-157 BID | One drop twice a day for 7 days (PRO-157=pazufloxacin 0.6%) |
| BG001 | PRO-157 TID | One drop three times a day for 7 days (PRO-157=pazufloxacin 0.6%) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline Bacterial Culture | Efficacy will be determined comparing the cultures of the lower conjunctival pouch, of the baseline (day 1) against final visit (day 8), quantifying and identifying the colony forming units (CFU) by genus and species. The evaluated variable is discrete quantitative type and the scale of measurement used will be CFU x mL considering the eradication, reduction or proliferation of the bacterial agent. It will be determined as effective if there is a reduction in number of bacterial flora in at least 95% of the evaluated subjects. | Treatment analysis, a culture was performed per eye | Posted | Number | cultures | up to one week | cultures | cultures |
|
Adverse events were monitored during the intervention period for 8 days, and a follow-up call was made 15 days after the final visit.
Adverse events were recorded according to the patient's scheduled or unscheduled visits, and were given a diary in which they could make annotations of their symptoms, the investigator reviewed these symptoms and reported on them The format of adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PRO-157 BID (2 Times Per Day) | 60 eyes will be evaluated with the following therapeutic regimen:
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| urinary tract infection (ITU) | Renal and urinary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eyelid ecchymosis | Eye disorders | Non-systematic Assessment |
In the present study the efficacy of pazufloxacin at different doses has not been demonstrated. In addition, the minimum inhibitory dose for ophthalmic administration is not established. Cultures could also not be determined in all study subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical pharmacologist | Laboratorios Sophia | +52 (33) 3001 4200 | 1259 | ricardo.llamas@sophia.com.mx |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2016 | Apr 2, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003234 | Conjunctivitis, Bacterial |
| ID | Term |
|---|---|
| D015818 | Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C078052 | pazufloxacin |
| D009883 | Ophthalmic Solutions |
| D000077266 | Moxifloxacin |
| D000077734 | Gatifloxacin |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
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|
| Gatifloxacin (Zymar®) | Active Comparator | 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
|
|
|
| Vigamox | Drug | Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution |
|
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| Zymar® | Drug | Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution |
|
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| Lagricel Ofteno® | Drug | Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution |
|
|
| Number of Cases of Conjunctival Hyperemia | Conjunctival hyperemia: qualitative ordinal variable. The conjunctival hyperemia was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group. | up to one week |
| Chemosis Frequency | Chemosis: qualitative ordinal variable, measurement scale absent or present. The chemosis was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group. | up to one week |
| Eyelid Edema Frequency | Eyelid edema: qualitative ordinal variable, measurement scale absent or present.Between baseline (day 0) versus final visit (day 7). The eyelid edema was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group. | Up to one week |
| Frequency of Corneal Epithelial Defects | Corneal epithelial defects: qualitative ordinal variable, measurement scale present or absent. The corneal epithelial defects was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group. | Up to one week |
| Excluded from analysis |
|
| Lack of Efficacy |
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| Did not receive intervention |
|
| BG002 | PRO-157 QID | One drop three times a day for 7 days (PRO-157=pazufloxacin 0.6%) |
| BG003 | Moxifloxacine | One drop four times a day for 7 days Moxifloxacin 0.5% (Vigamox®). |
| BG004 | Gatifloxacine | One drop four times a day for 7 days Gatifloxacin 0.3% (Zymar®). |
| BG005 | Total | Total of all reporting groups |
| eyes |
|
| Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
| OG001 | PRO-157 TID (3 Times Per Day) | 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution |
| OG002 | PRO-157 QID (4 Times Per Day) | 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen:
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution |
| OG003 | Moxifloxacin (Vigamox®) | 60 eyes will be evaluated with the following therapeutic regimen:
Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution |
| OG004 | Gatifloxacin (Zymar®) | 60 eyes will be evaluated with the following therapeutic regimen:
Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution |
|
|
|
| Primary | Adverse Events | Number of adverse events: dependent variable, discrete quantitative, the number of adverse events per group will be compared at the end of the study and it will be considered safe if there is not greater increase of 5% of serious adverse events. | Treatment analysis | Posted | Number | events | during the intervention period for 7 days, and 15 days after the final visit | eyes | eyes |
|
|
|
|
| Secondary | Cases Frequency of Ocular Secretion | Secretion ocular: qualitative ordinal variable. The secretion was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group. | treatment analysis. | Posted | Number | secretion cases reported | Up to one week. | eyes | eyes |
|
|
|
|
| Secondary | Number of Cases of Conjunctival Hyperemia | Conjunctival hyperemia: qualitative ordinal variable. The conjunctival hyperemia was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group. | Treatment analysis | Posted | Number | hyperemia cases reported | up to one week | eyes | eyes |
|
|
|
|
| Secondary | Chemosis Frequency | Chemosis: qualitative ordinal variable, measurement scale absent or present. The chemosis was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group. | Treatment analysis | Posted | Number | chemosis cases reported | up to one week | eyes | eyes |
|
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|
| Secondary | Eyelid Edema Frequency | Eyelid edema: qualitative ordinal variable, measurement scale absent or present.Between baseline (day 0) versus final visit (day 7). The eyelid edema was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group. | Treatment analysis | Posted | Number | eyelid edema cases reported | Up to one week | eyes | eyes |
|
|
|
|
| Secondary | Frequency of Corneal Epithelial Defects | Corneal epithelial defects: qualitative ordinal variable, measurement scale present or absent. The corneal epithelial defects was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group. | Treatment analysis | Posted | Number | Corneal defects cases reported | Up to one week | eyes | eyes |
|
|
|
|
| 0 |
| 30 |
| 7 |
| 30 |
| EG001 | PRO-157 TID (3 Times Per Day) | 60 eyes will be evaluated with the following therapeutic regimen:
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution | 0 | 30 | 5 | 30 |
| EG002 | PRO-157 QID (4 Times Per Day) | 60 eyes will be evaluated with the following therapeutic regimen:
PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution | 0 | 30 | 7 | 30 |
| EG003 | Moxifloxacin (Vigamox®) | 60 eyes will be evaluated with the following therapeutic regimen:
Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution | 1 | 30 | 3 | 30 |
| EG004 | Gatifloxacin (Zymar®) | 60 eyes will be evaluated with the following therapeutic regimen:
Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution | 1 | 30 | 6 | 30 |
| ischemic optic neuropathy | Eye disorders | Non-systematic Assessment |
|
| stomach flu | Gastrointestinal disorders | Non-systematic Assessment |
|
| hordeolum | Eye disorders | Non-systematic Assessment |
|
| Dysgeusia | Gastrointestinal disorders | Non-systematic Assessment |
|
| eye pain | Eye disorders | Systematic Assessment |
|
| dizziness | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Numular keratitis | Eye disorders | Non-systematic Assessment |
|
| gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Lack of effectiveness | General disorders | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Irritant conjunctivitis | Eye disorders | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Systemic hypertension | Vascular disorders | Systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | Non-systematic Assessment |
|
| Preseptal cellulitis | Eye disorders | Non-systematic Assessment |
|
| stomachache | Gastrointestinal disorders | Non-systematic Assessment |
|
PI (s) can not make use of the partial or total information of this investigation, due to the clauses contained in the agreement of confidentiality of the study.
| D015817 | Eye Infections |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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