Conjunctivitis, BacterialPhase 3PRO-157NCT03696342
Efficacy of the Ophthalmic Pazufloxacin 0.6% for Bacterial Conjunctivitis, Compared to Gatifloxacin 0.3%.
A Phase 3 study testing Pazufloxacin and Zymar in people with Conjunctivitis, Bacterial, run by Laboratorios Sophia S.A de C.V. at 6 sites in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 99 years
- Conditions the study is for
- Conjunctivitis, Bacterial
- What is being tested?
- Pazufloxacin and Zymar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 6 sitesMexico
- Study dates
- 1 Oct 2018to 24 Mar 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent.
- Age ≥ 1 year.
- Both genders.
- Clinical picture of acute bacterial conjunctivitis defined by: Conjunctival secretion and conjunctival bulbar hyperemia
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Mexico6 sites
Centro de investigación Medica Aguascalientes
Aguascalientes, 20116
Juan Carlos Serna Ojeda (INBIOMEDyC)
Aguascalientes, 20190
Consultorio Dra. Patricia Culebro Solano
Guadalajara, Jalisco, 44100
Juan Carlos Ochoa Tavares
Guadalajara, Jalisco, 44600
Samuel altamirano Vallejo
Guadalajara, Jalisco, 44670
Instituto Nacional de Pediatria
Mexico City, 04530
About this study
Official title: Clinical Study of the Efficacy of the Ophthalmic Solution of Pazufloxacin 0.6% (PRO-157) for the Treatment of Acute Bacterial Conjunctivitis, Compared to the Ophthalmic Solution of Gatifloxacin 0.3%.
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.
Read more
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).
Read the 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.
- Conditions
- Conjunctivitis, Bacterial
- Being tested
- Pazufloxacin, Zymar
- Keywords
- pazufloxacin, PRO-157, Fluoroquinolones
- Medical subject headings
- Conjunctivitis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazufloxacinDrug
Also called 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.
ZymarDrug
Also called gatifloxacin
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.
| Study group | Role | What they receive |
|---|---|---|
| PRO-157 | Experimental | 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. Receives: Drug: Pazufloxacin |
| Zymar | Active comparator | 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. Receives: Drug: Zymar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: will be evaluated at the end of the treatment (day 8, final visit)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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".
Measured: will be evaluated at the end of the treatment (day 8, final visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start1 Oct 2018
- Primary completion24 Mar 2020
- Study completion24 Mar 2020
Why it stopped: Sponsor's convenience
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Conjunctivitis, BacterialStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- clinical study of non-inferiority, multicenter, double-blind, with comparative group randomized
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leopoldo Baiza Durán, MD, Study director, Laboratorios Sophia S.A de C.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696342
- Sponsor's protocol ID
- SOPH157-0217/III
- Acronym
- PRO-157
- Status last verified
- Mar 2021
- First submitted
- 3 Oct 2018
- Last updated
- 24 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Efficacy of the Ophthalmic Solution of Pazufloxacin 0.6% (PRO-157) for the Treatment of Acute Bacterial Conjunctivitis, Compared to the Ophthalmic Solution of Gatifloxacin 0.3%.
- ClinicalTrials.gov ID
- NCT03696342
- Acronym / sponsor ID
- PRO-157 / SOPH157-0217/III
- Conditions
- Conjunctivitis, Bacterial
- Keywords
- pazufloxacin, PRO-157, Fluoroquinolones
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's convenience
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Posted 24 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- clinical study of non-inferiority, multicenter, double-blind, with comparative group randomized
| Arm | Type | Receives |
|---|---|---|
| PRO-157 | Experimental | Drug: PazufloxacinPazufloxacin 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. |
| Zymar | Active comparator | Drug: ZymarGatifloxacin 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. |
Who may qualify
- Ages
- 1 year to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent.
- Age ≥ 1 year.
- Both genders.
- Clinical picture of acute bacterial conjunctivitis defined by: Conjunctival secretion and conjunctival bulbar hyperemia
Key exclusion criteria (15 listed)
- 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.
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 |
|---|---|---|
| PazufloxacinAlso: PRO-157Pazufloxacin 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 | PRO-157 |
| ZymarAlso: gatifloxacinGatifloxacin 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 |
Primary outcome
Amount of Conjunctival Secretion Present in Each Patient by the End of Treatment
Time frame: 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
Time frame: 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.
4 secondary outcomes
Overall Rating (Global Qualification) of Product's Efficacy as Classified by Main Investigator by the End of Treatment
Time frame: will be evaluated at the end of the treatment (day 8, final visit)
Presence of Bacterial Eradication Compared to Baseline Culture Results
Time frame: will be evaluated at the end of the treatment (day 8, final visit)
Adverse Events
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
Time frame: will be evaluated at the end of the treatment (day 8, final visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Leopoldo Baiza Durán, MD study director
Laboratorios Sophia S.A de C.V.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pazufloxacin and Zymar in people with Conjunctivitis, Bacterial, run by Laboratorios Sophia S.A de C.V. at 6 sites in Mexico.
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 15 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: stopped early, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Mexico. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 24 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Amount of Conjunctival Secretion Present in Each Patient by the End of Treatment (time frame: will be evaluated at the end of the treatment (day 8, final visit)). The study lists 2 primary outcomes in all. 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 24 Aug 2021.