Conjunctivitis, Bacterial
Conditions
Keywords
pazufloxacin, PRO-157, Fluoroquinolones
Brief summary
Phase III clinical study of non-inferiority, multicenter, double-blind, with comparative group, of parallel groups and randomized. about a ophthalmic topical antibiotic for the treatment of bacterial conjunctivitis. Goal:To compare the efficacy of the ophthalmic solution of pazufloxacin 0.6%, against the ophthalmic solution of gatifloxacin 0.3%, in the treatment of acute bacterial conjunctivitis. Hypothesis:the ophthalmic solution PRO-157 is not inferior in the treatment of bacterial conjunctivitis, compared to the ophthalmic solution of gatifloxacin 0.3%, by means of the clinical remission of the disease. Number of patients: 160 patients, each one will provide an eye for efficacy analysis, divided into 2 groups (80 eyes per group).
Detailed description
The study subjects will be recruited from various research centers in western and central Mexico. Each research center has a monitoring plan specified according to the recruitment capabilities of the same, which must be at least once a month, where the queries of your data entered into the electronic case report report will be reported to the center. (e-CRF) for which it has as time limit the next monitoring visit to make the pertinent changes. The report of adverse events will be made according to the standard operating procedure (PNO) where it specifies, according to Official Mexican Standard 220 (NOM 220), that the signs or symptoms of adverse events will be reported based on the Medical Dictionary. for Regulatory Activities, for which the sponsor has version 20.1 in Spanish. For serious adverse events (SAEs) will be reported in accordance with the standardized operation procedure of pharmacovigilance of the sponsor, which adheres to the guidelines of NOM 220 and international regulations, these will be reported in the regulatory framework to the regulatory entity within a period of time no more than 7 days. The study is registered in the National Registry of Clinical Trials (RNEC), entity equivalent to Clinical Trials in Mexico. The quality assurance plan is carried out by the sponsor through the Quality Assurance agent in Clinical Research, whose function is to conduct inspections and audits of the research sites to document and generate reports of deviations from the protocol. In addition to the visits of the monitoring plan, the reliability of the data is guaranteed. To verify the integrity, veracity and reliability of the data entered into the e-CRF, the monitors of each center will check the information uploaded to the portal with that reported in the source document of the principal investigator (PI), such as clinical notes, clinical history and documents. and formats attached to the research protocol, physical case report format, as well as those provided by the sponsor to the PI (subject's diary and quality and satisfaction survey). The e-CRF used for this clinical study is provided by an internationally certified provider with the highest quality standards, protection of information under current regulations and confidentiality guarantee. The information that the PIs enter into the e-CRF is collated and verified by the clinical monitors and by the service provider's personnel, later reviewed and approved by the medical ophthalmologist researcher and by the Clinical Security Pharmacologist, who authorize the monitored data of clinical information and safety of the study molecule, respectively.
Interventions
DRUGPazufloxacin
Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
DRUGZymar
Gatifloxacin 0.3%. by Allergan, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Sponsors
Laboratorios Sophia S.A de C.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
In addition, the statistical analysis will be carried out in a blinded manner in the case of a partial and final analysis. The masking will be done using boxes in the primary packaging identical in the two groups and relabelling the bottles of both interventions. Blinding for the research subject and the researcher will be done by replacing the commercial labels in the case of the comparator in the bottles and the use of identical labels that contain the assignment number.
Intervention model description
clinical study of non-inferiority, multicenter, double-blind, with comparative group randomized
Eligibility
Sex/Gender
ALL
Age
1 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed consent. * Age ≥ 1 year. * Both genders. * Clinical picture of acute bacterial conjunctivitis defined by: Conjunctival secretion and conjunctival bulbar hyperemia
Exclusion criteria
* Pregnant women, lactating or planning to become pregnant. * Women of reproductive age and who do not have a hormonal contraceptive method, intrauterine device or bilateral tubal obstruction. * Participation in another clinical research study ≤ 30 days before the baseline visit. * Previous participation in this same study. * That they can not comply with their attendance at appointments or with all the requirements of the protocol. * Single eye * Presence of corneal abrasion or corneal ulceration in the study eye. * History Users of contact lenses who are not willing to suspend their use during the study. * Users of any formulation with ophthalmic application, including lubricants, that can not, or do not want to suspend it during the study. * Antecedents of eye surgery 6 weeks prior to study entry. * Viral or allergic conjunctivitis. * Active uveitis. * Active ulcerative keratitis. * Recurrent corneal erosion syndrome * Antecedent of hypersensitivity or allergy to fluoroquinolones.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Conjunctival Secretion Present in Each Patient by the End of Treatment | will be evaluated at the end of the treatment (day 8, final visit) | The ocular secretion will be classified as 0 = absent, 1 = mild, 2 = moderate and 3 = severe. The number will be reported according to the rating granted at final visit. |
| Severeness of Conjunctival Bulbar Hyperemia in Each Patient by the End of Treatment | will be evaluated at the end of the treatment (day 8, final visit) | Conjunctival hyperemia is defined as the simplest reaction of the conjunctiva to a stimulus, a red appearance secondary to the vasodilation of the conjunctival vessels of variable intensity. Will be graduated using the Efron scale. 0 Normal , 1 Very slight, 2 Mild, 3 Moderate, 4 Severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Rating (Global Qualification) of Product's Efficacy as Classified by Main Investigator by the End of Treatment | will be evaluated at the end of the treatment (day 8, final visit) | The global qualification of the investigator constitutes the integral judgment of the clinical picture of the subject, including signs and symptoms, after a routine ophthalmological evaluation and interrogation. It will be classified 0 = cure, 1 = improvement, 2 = no changes compared to before starting treatment, 3 = worsened. It will be registered in the CRF in each of the follow-up visits. |
| Presence of Bacterial Eradication Compared to Baseline Culture Results | will be evaluated at the end of the treatment (day 8, final visit) | The conjunctival secretion sample will be taken prior to the instillation of any medication, the result of the basal crop will be compared against the results of the final crop and the absence of bacterial species that were present in the culture of the baseline visit is considered bacterial eradication. |
| Adverse Events | day 0 to day 17 (visit 0 to security call) | The evaluation of adverse events requires a questioning conducted by the principal investigator and the appropriate exploratory techniques for its detection. the number of adverse events per study group will be considered for the analysis |
| Presence of Clinical Remission Defined as Absence of Hyperemia and Secretion by the Final Visit | will be evaluated at the end of the treatment (day 8, final visit) | The clinical remission in the visits will be evaluated as Yes or No, to report Yes it must have a grade of 0 in conjunctival hyperemia and 0 in secretion; otherwise, you must report as No. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PRO-157 Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Pazufloxacin: Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days. | 23 |
| Zymar Gatifloxacin 0.3%. by Allergan, topical ophthalmic 1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days.
Zymar: Gatifloxacin 0.3%. by Allergan, topical ophthalmic
1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days. | 23 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Total | PRO-157 | Zymar |
|---|---|---|---|
| Age, Continuous | 48.22 years STANDARD_DEVIATION 25.9 | 46.78 years STANDARD_DEVIATION 22.8 | 49.65 years STANDARD_DEVIATION 29.2 |
| Concomitant medication | 23 Participants | 11 Participants | 12 Participants |
| Positive culture | 24 Participants | 8 Participants | 16 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment Mexico | 46 participants | 23 participants | 23 participants |
| Severe bulbar conjunctival hyperemia | 7 Participants | 3 Participants | 4 Participants |
| Severe conjunctival secretion | 9 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Female | 20 Participants | 9 Participants | 11 Participants |
| Sex: Female, Male Male | 26 Participants | 14 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 20 / 23 | 18 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
Primary
Amount of Conjunctival Secretion Present in Each Patient by the End of Treatment
The ocular secretion will be classified as 0 = absent, 1 = mild, 2 = moderate and 3 = severe. The number will be reported according to the rating granted at final visit.
Time frame: will be evaluated at the end of the treatment (day 8, final visit)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRO-157 | Amount of Conjunctival Secretion Present in Each Patient by the End of Treatment | Absent | 20 Participants |
| PRO-157 | Amount of Conjunctival Secretion Present in Each Patient by the End of Treatment | Mild | 2 Participants |
| Zymar | Amount of Conjunctival Secretion Present in Each Patient by the End of Treatment | Absent | 21 Participants |
| Zymar | Amount of Conjunctival Secretion Present in Each Patient by the End of Treatment | Mild | 2 Participants |
Primary
Severeness of Conjunctival Bulbar Hyperemia in Each Patient by the End of Treatment
Conjunctival hyperemia is defined as the simplest reaction of the conjunctiva to a stimulus, a red appearance secondary to the vasodilation of the conjunctival vessels of variable intensity. Will be graduated using the Efron scale. 0 Normal , 1 Very slight, 2 Mild, 3 Moderate, 4 Severe.
Time frame: will be evaluated at the end of the treatment (day 8, final visit)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRO-157 | Severeness of Conjunctival Bulbar Hyperemia in Each Patient by the End of Treatment | Normal | 17 Participants |
| PRO-157 | Severeness of Conjunctival Bulbar Hyperemia in Each Patient by the End of Treatment | Very mild | 5 Participants |
| Zymar | Severeness of Conjunctival Bulbar Hyperemia in Each Patient by the End of Treatment | Normal | 20 Participants |
| Zymar | Severeness of Conjunctival Bulbar Hyperemia in Each Patient by the End of Treatment | Very mild | 3 Participants |
Secondary
Adverse Events
The evaluation of adverse events requires a questioning conducted by the principal investigator and the appropriate exploratory techniques for its detection. the number of adverse events per study group will be considered for the analysis
Time frame: day 0 to day 17 (visit 0 to security call)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PRO-157 | Adverse Events | Mild Adverse Event | 25 number of adverse events |
| PRO-157 | Adverse Events | Moderate Adverse Event | 0 number of adverse events |
| Zymar | Adverse Events | Mild Adverse Event | 27 number of adverse events |
| Zymar | Adverse Events | Moderate Adverse Event | 2 number of adverse events |
Secondary
Overall Rating (Global Qualification) of Product's Efficacy as Classified by Main Investigator by the End of Treatment
The global qualification of the investigator constitutes the integral judgment of the clinical picture of the subject, including signs and symptoms, after a routine ophthalmological evaluation and interrogation. It will be classified 0 = cure, 1 = improvement, 2 = no changes compared to before starting treatment, 3 = worsened. It will be registered in the CRF in each of the follow-up visits.
Time frame: will be evaluated at the end of the treatment (day 8, final visit)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRO-157 | Overall Rating (Global Qualification) of Product's Efficacy as Classified by Main Investigator by the End of Treatment | Cure | 16 Participants |
| PRO-157 | Overall Rating (Global Qualification) of Product's Efficacy as Classified by Main Investigator by the End of Treatment | Improvement | 6 Participants |
| Zymar | Overall Rating (Global Qualification) of Product's Efficacy as Classified by Main Investigator by the End of Treatment | Cure | 19 Participants |
| Zymar | Overall Rating (Global Qualification) of Product's Efficacy as Classified by Main Investigator by the End of Treatment | Improvement | 4 Participants |
Secondary
Presence of Bacterial Eradication Compared to Baseline Culture Results
The conjunctival secretion sample will be taken prior to the instillation of any medication, the result of the basal crop will be compared against the results of the final crop and the absence of bacterial species that were present in the culture of the baseline visit is considered bacterial eradication.
Time frame: will be evaluated at the end of the treatment (day 8, final visit)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRO-157 | Presence of Bacterial Eradication Compared to Baseline Culture Results | 19 Participants |
| Zymar | Presence of Bacterial Eradication Compared to Baseline Culture Results | 22 Participants |
Secondary
Presence of Clinical Remission Defined as Absence of Hyperemia and Secretion by the Final Visit
The clinical remission in the visits will be evaluated as Yes or No, to report Yes it must have a grade of 0 in conjunctival hyperemia and 0 in secretion; otherwise, you must report as No.
Time frame: will be evaluated at the end of the treatment (day 8, final visit)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRO-157 | Presence of Clinical Remission Defined as Absence of Hyperemia and Secretion by the Final Visit | 15 Participants |
| Zymar | Presence of Clinical Remission Defined as Absence of Hyperemia and Secretion by the Final Visit | 19 Participants |