Trial · NCT02980523
Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin)
NCT02980523, Phase 2, Completed, Laboratorios Sophia S.A de C.V.; results first posted 2019-02-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin). Trials, record NCT02980523. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02980523
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin)
- NCT number
- NCT02980523
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 150 participants, actual
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Conditions
- Bacterial Conjunctivitis
- Interventions
- PRO-157, Vigamox, Zymar®, Lagricel Ofteno®
- First posted
- 2016-12-02
- Last updated
- 2019-05-22
- Results first posted
- 2019-02-15
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline Bacterial Culture | up to one week | 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. |
| Primary | Adverse Events | during the intervention period for 7 days, and 15 days after the final visit | 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. |
| Secondary | Cases Frequency of Ocular Secretion | Up to one week. | 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. |
| Secondary | Number of Cases of Conjunctival Hyperemia | up to one week | 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. |
| Secondary | Chemosis Frequency | up to one week | 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. |
| Secondary | Eyelid Edema Frequency | Up to one week | 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. |
| Secondary | Frequency of Corneal Epithelial Defects | Up to one week | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline Bacterial Culture | up to one week | Treatment analysis, a culture was performed per eye | cultures | NUMBER |
| PRIMARY | Adverse Events | during the intervention period for 7 days, and 15 days after the final visit | Treatment analysis | events | NUMBER |
| SECONDARY | Cases Frequency of Ocular Secretion | Up to one week. | treatment analysis. | secretion cases reported | NUMBER |
| SECONDARY | Number of Cases of Conjunctival Hyperemia | up to one week | Treatment analysis | hyperemia cases reported | NUMBER |
| SECONDARY | Chemosis Frequency | up to one week | Treatment analysis | chemosis cases reported | NUMBER |
| SECONDARY | Eyelid Edema Frequency | Up to one week | Treatment analysis | eyelid edema cases reported | NUMBER |
| SECONDARY | Frequency of Corneal Epithelial Defects | Up to one week | Treatment analysis | Corneal defects cases reported | NUMBER |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline Bacterial Culture | PRO-157 BID (2 Times Per Day) | basal cultures positives | 30 | cultures | |
| Change From Baseline Bacterial Culture | PRO-157 TID (3 Times Per Day) | basal cultures positives | 16 | cultures | |
| Change From Baseline Bacterial Culture | PRO-157 QID (4 Times Per Day) | basal cultures positives | 26 | cultures | |
| Change From Baseline Bacterial Culture | Moxifloxacin (Vigamox®) | basal cultures positives | 29 | cultures | |
| Change From Baseline Bacterial Culture | Gatifloxacin (Zymar®) | basal cultures positives | 17 | cultures | |
| Change From Baseline Bacterial Culture | PRO-157 BID (2 Times Per Day) | final cultures negatives | 17 | cultures | |
| Change From Baseline Bacterial Culture | PRO-157 TID (3 Times Per Day) | final cultures negatives | 14 | cultures | |
| Change From Baseline Bacterial Culture | PRO-157 QID (4 Times Per Day) | final cultures negatives | 16 | cultures | |
| Change From Baseline Bacterial Culture | Moxifloxacin (Vigamox®) | final cultures negatives | 28 | cultures | |
| Change From Baseline Bacterial Culture | Gatifloxacin (Zymar®) | final cultures negatives | 15 | cultures |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PRO-157 BID (2 Times Per Day) | 30 | 60 |
| Overall Study | STARTED | PRO-157 TID (3 Times Per Day) | 30 | 60 |
| Overall Study | STARTED | PRO-157 QID (4 Times Per Day) | 30 | 60 |
| Overall Study | STARTED | Moxifloxacin (Vigamox®) | 30 | 60 |
| Overall Study | STARTED | Gatifloxacin (Zymar®) | 30 | 60 |
| Overall Study | COMPLETED | PRO-157 BID (2 Times Per Day) | 27 | 54 |
| Overall Study | COMPLETED | PRO-157 TID (3 Times Per Day) | 19 | 38 |
| Overall Study | COMPLETED | PRO-157 QID (4 Times Per Day) | 24 | 48 |
| Overall Study | COMPLETED | Moxifloxacin (Vigamox®) | 21 | 42 |
| Overall Study | COMPLETED | Gatifloxacin (Zymar®) | 20 | 40 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events95
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 | Eyelid ecchymosis | Eye disorders | PRO-157 BID (2 Times Per Day) | 0 | 30 | 0 |
| other | Eyelid ecchymosis | Eye disorders | PRO-157 TID (3 Times Per Day) | 1 | 30 | 1 |
| other | Eyelid ecchymosis | Eye disorders | PRO-157 QID (4 Times Per Day) | 0 | 30 | 0 |
| other | Eyelid ecchymosis | Eye disorders | Moxifloxacin (Vigamox®) | 0 | 30 | 0 |
| other | Eyelid ecchymosis | Eye disorders | Gatifloxacin (Zymar®) | 0 | 30 | 0 |
| other | stomach flu | Gastrointestinal disorders | PRO-157 BID (2 Times Per Day) | 0 | 30 | 0 |
| other | stomach flu | Gastrointestinal disorders | PRO-157 TID (3 Times Per Day) | 1 | 30 | 1 |
| other | stomach flu | Gastrointestinal disorders | PRO-157 QID (4 Times Per Day) | 0 | 30 | 0 |
| other | stomach flu | Gastrointestinal disorders | Moxifloxacin (Vigamox®) | 0 | 30 | 0 |
| other | stomach flu | Gastrointestinal disorders | Gatifloxacin (Zymar®) | 0 | 30 | 0 |
1 to 10 of 95Source ClinicalTrials.gov
See all 95 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PRO-157 BID (2 Times Per Day) | ||
| Total, all-cause mortality | PRO-157 TID (3 Times Per Day) | ||
| Total, all-cause mortality | PRO-157 QID (4 Times Per Day) | ||
| Total, all-cause mortality | Moxifloxacin (Vigamox®) | ||
| Total, all-cause mortality | Gatifloxacin (Zymar®) | ||
| Total, other adverse events | PRO-157 BID (2 Times Per Day) | 7 | 30 |
| Total, other adverse events | PRO-157 TID (3 Times Per Day) | 5 | 30 |
| Total, other adverse events | PRO-157 QID (4 Times Per Day) | 7 | 30 |
| Total, other adverse events | Moxifloxacin (Vigamox®) | 3 | 30 |
| Total, other adverse events | Gatifloxacin (Zymar®) | 6 | 30 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02980523
GET https://conductscience.org/api/trials/v1/NCT02980523/results?page=2