A Phase 3 interventional study of Pazufloxacin and Zymar in Conjunctivitis, Bacterial, sponsored by Laboratorios Sophia S.A de C.V.. Terminated at 6 sites in Mexico. Open to participants aged 1 Year to 99 Years. Per ClinicalTrials.gov, last updated 2021-08-24.
Sponsored by Laboratorios Sophia S.A de C.V. · Phase 3, Interventional, and Treatment
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).
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.
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 46 is below the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.
Browse Conjunctivitis, Bacterial studies →Laboratorios Sophia S.A de C.V. is the lead sponsor of 45 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Pazufloxacin
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.
Drug: Zymar
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.
Also known as: PRO-157
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.
Also known as: gatifloxacin
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)
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)
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)
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)
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)
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)
| Milestone | PRO-157 | Zymar |
|---|---|---|
| Started | 23 | 23 |
| Completed | 22 | 23 |
| Not completed | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
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.
| Participants | PRO-157 | Zymar |
|---|---|---|
| Absent | 20 | 21 |
| Mild | 2 | 2 |
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.
| Participants | PRO-157 | Zymar |
|---|---|---|
| Normal | 17 | 20 |
| Very mild | 5 | 3 |
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.
| Participants | PRO-157 | Zymar |
|---|---|---|
| Cure | 16 | 19 |
| Improvement | 6 | 4 |
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.
| Participants | PRO-157 | Zymar |
|---|---|---|
| Presence of Bacterial Eradication Compared to Baseline Culture Results | 19 | 22 |
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
| number of adverse events | PRO-157 | Zymar |
|---|---|---|
| Mild Adverse Event | 25 | 27 |
| Moderate Adverse Event | 0 | 2 |
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".
| Participants | PRO-157 | Zymar |
|---|---|---|
| Presence of Clinical Remission Defined as Absence of Hyperemia and Secretion by the Final Visit | 15 | 19 |
Collected over From day 1 (basal visit) to the safety call on day 15 (±2 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PRO-157 | 0/23 (0%) | 0/23 (0%) | 20/23 (87%) |
| Zymar | 0/23 (0%) | 0/23 (0%) | 18/23 (78.3%) |
| Event | PRO-157 | Zymar |
|---|---|---|
| Burning sensationEye disorders | 19/23 | 15/23 |
| PruritusEye disorders | 3/23 | 3/23 |
| HeadacheNervous system disorders | 0/23 | 2/23 |
| Ocular PainEye disorders | 0/23 | 2/23 |
| BlepharoedemaEye disorders | 0/23 | 2/23 |
| SprainMusculoskeletal and connective tissue disorders | 0/23 | 1/23 |
| Palpebral hyperemiaEye disorders | 0/23 | 1/23 |
| Ocular irritationEye disorders | 0/23 | 1/23 |
| TearingEye disorders | 1/23 | 1/23 |
| Preexcitation syndromeCardiac disorders | 0/23 | 1/23 |
| Age, Continuous(years) | PRO-157 | Zymar | Total |
|---|---|---|---|
| Mean | 46.78 ± 22.8 | 49.65 ± 29.2 | 48.22 ± 25.9 |
| Sex: Female, Male(Participants) | PRO-157 | Zymar | Total |
|---|---|---|---|
| Female | 9 | 11 | 20 |
| Male | 14 | 12 | 26 |
| Race and Ethnicity Not Collected(Participants) | PRO-157 | Zymar | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | PRO-157 | Zymar | Total |
|---|---|---|---|
| Mexico | 23 | 23 | 46 |
| Concomitant medication(Participants) | PRO-157 | Zymar | Total |
|---|---|---|---|
| Count of participants | 11 | 12 | 23 |
| Positive culture(Participants) | PRO-157 | Zymar | Total |
|---|---|---|---|
| Count of participants | 8 | 16 | 24 |
| Severe conjunctival secretion(Participants) | PRO-157 | Zymar | Total |
|---|---|---|---|
| Count of participants | 4 | 5 | 9 |
| Severe bulbar conjunctival hyperemia(Participants) | PRO-157 | Zymar | Total |
|---|---|---|---|
| Count of participants | 3 | 4 | 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is terminated, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Laboratorios Sophia S.A de C.V. →