Trial · NCT03696342
Efficacy of the Ophthalmic Pazufloxacin 0.6% for Bacterial Conjunctivitis, Compared to Gatifloxacin 0.3%.
NCT03696342, Phase 3, Terminated, Laboratorios Sophia S.A de C.V.; results first posted 2021-08-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of the Ophthalmic Pazufloxacin 0.6% for Bacterial Conjunctivitis, Compared to Gatifloxacin 0.3%. Trials, record NCT03696342. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03696342
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of the Ophthalmic Pazufloxacin 0.6% for Bacterial Conjunctivitis, Compared to Gatifloxacin 0.3%.
- NCT number
- NCT03696342
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 46 participants, actual
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Conditions
- Conjunctivitis, Bacterial
- Interventions
- Pazufloxacin, Zymar
- First posted
- 2018-10-04
- Last updated
- 2021-08-24
- Results first posted
- 2021-08-24
- Limitations and caveats
- This trial was terminated early due to the sponsor's convenience in the pipeline followed by the studied product. A small sample renders this results as merely descriptive.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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 |
| Secondary | 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". |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | 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) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Presence of Bacterial Eradication Compared to Baseline Culture Results | will be evaluated at the end of the treatment (day 8, final visit) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Adverse Events | day 0 to day 17 (visit 0 to security call) | number of adverse events | NUMBER | |
| SECONDARY | 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) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Amount of Conjunctival Secretion Present in Each Patient by the End of Treatment | PRO-157 | Absent | 20 | Participants | |
| Amount of Conjunctival Secretion Present in Each Patient by the End of Treatment | Zymar | Absent | 21 | Participants | |
| Amount of Conjunctival Secretion Present in Each Patient by the End of Treatment | PRO-157 | Mild | 2 | Participants | |
| Amount of Conjunctival Secretion Present in Each Patient by the End of Treatment | Zymar | Mild | 2 | Participants | |
| Severeness of Conjunctival Bulbar Hyperemia in Each Patient by the End of Treatment | PRO-157 | Normal | 17 | Participants | |
| Severeness of Conjunctival Bulbar Hyperemia in Each Patient by the End of Treatment | Zymar | Normal | 20 | Participants | |
| Severeness of Conjunctival Bulbar Hyperemia in Each Patient by the End of Treatment | PRO-157 | Very mild | 5 | Participants | |
| Severeness of Conjunctival Bulbar Hyperemia in Each Patient by the End of Treatment | Zymar | Very mild | 3 | Participants | |
| Overall Rating (Global Qualification) of Product's Efficacy as Classified by Main Investigator by the End of Treatment | PRO-157 | Cure | 16 | Participants | |
| Overall Rating (Global Qualification) of Product's Efficacy as Classified by Main Investigator by the End of Treatment | Zymar | Cure | 19 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PRO-157 | 23 | 23 |
| Overall Study | STARTED | Zymar | 23 | 23 |
| Overall Study | COMPLETED | PRO-157 | 22 | 22 |
| Overall Study | COMPLETED | Zymar | 23 | 23 |
| Overall Study | NOT COMPLETED | PRO-157 | 1 | 1 |
| Overall Study | NOT COMPLETED | Zymar | 0 | 0 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Burning sensation | Eye disorders | PRO-157 | 19 | 23 | 19 |
| other | Burning sensation | Eye disorders | Zymar | 15 | 23 | 15 |
| other | Headache | Nervous system disorders | PRO-157 | 0 | 23 | 0 |
| other | Headache | Nervous system disorders | Zymar | 2 | 23 | 2 |
| other | Ocular Pain | Eye disorders | PRO-157 | 0 | 23 | 0 |
| other | Ocular Pain | Eye disorders | Zymar | 2 | 23 | 2 |
| other | Blepharoedema | Eye disorders | PRO-157 | 0 | 23 | 0 |
| other | Blepharoedema | Eye disorders | Zymar | 2 | 23 | 2 |
| other | Sprain | Musculoskeletal and connective tissue disorders | PRO-157 | 0 | 23 | 0 |
| other | Sprain | Musculoskeletal and connective tissue disorders | Zymar | 1 | 23 | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PRO-157 | 0 | 23 |
| Total, all-cause mortality | Zymar | 0 | 23 |
| Total, other adverse events | PRO-157 | 20 | 23 |
| Total, other adverse events | Zymar | 18 | 23 |
| Total, serious adverse events | PRO-157 | 0 | 23 |
| Total, serious adverse events | Zymar | 0 | 23 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PRO-157 vs Zymar: Presence of Clinical Remission Defined as Absence of Hyperemia and Secretion by the Final Visit | Trial comparisons |
| PRO-157 vs Zymar: deaths from any cause | Trial comparisons |
| PRO-157 vs Zymar: Presence of Bacterial Eradication Compared to Baseline Culture Results | Trial comparisons |
| PRO-157 vs Zymar: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03696342
GET https://conductscience.org/api/trials/v1/NCT03696342/events?page=2