Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin)

• Sponsor: Laboratorios Sophia S.A de C.V. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02980523
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 5
• Duration (Months): 26
• Patients Per Site Per Month: 5.8

Study Details

Study Description

Brief Summary

A randomized, double blind, phase II multicenter trial with the objective of assess the safety and efficacy of the PRO-157 ophthalmic solution in three different dosing regimens, versus Moxifloxacin, versus Gatifloxacin in patients with bacterial conjunctivitis.

Number of participants: 300 eyes, 60 per group.

Criteria for evaluation:

Measurements of effectiveness: Main efficacy criterion It will be determined as effective if there is a reduction in number or species of bacterial flora by comparing the basal culture against the final culture among the five different patient groups.

Reduction or absence of infection with the clinical evaluation through signs and symptoms.

Safety Measurements: it will be determined by visual acuity and adverse events Patients recruited will be treated for 7, for protocol purpose, the infected eye (s) will be taken into account at the time of baseline, however the study medication and procedures will be applied and performed in both eyes to protect the healthy eye.

The study is divided into the following evaluation periods:

Visit 1 baseline (day 1), visit 2 (day 3), final visit (day 8) and a telephone call (day 23) for the evaluation of adverse events.

Subjects will be allocated to any of the following regimen dosages:

• PRO-157 1 drop 2 times daily

• PRO-157 1 drop 3 times daily

• PRO-157 1 drop 4 times daily

• Moxifloxacin 1 drop 3 times daily

• Gatifloxacin 1 drop 3 times daily. All regimen dosage will have a duration of 7 days. An artificial tear preservative free (Lagricel Ofteno®) will also be applied 15 minutes before instillation of study drug, during study period.

Data Analysis: The data will be analyzed by Intention to Treat (ITT) and per Protocol (PP) in which each of the variables is described, the ITT population will be constituted by all subjects recruited who have received at least one dose of the study, the PP population will be the subset of ITT composed of all subjects without any major deviation from the protocol and the bivariate analysis will be performed in this group.

Continuous quantitative variables are expressed and presented by measures of central tendency and dispersion (mean, standard deviation and ranges). Qualitative nominal and ordinal variables are presented by means of frequencies and proportions. The level of significance was an alpha of 0.05 or less.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Conjunctivitis	Drug: PRO-157; Drug: Vigamox; Drug: Zymar®; Drug: Lagricel Ofteno®	Phase 2

Detailed Description

Lagricel Ofteno® is a registered trademark, therefore the use of the same throughout the document can not be translated into the English language.

PRO-157, the acronym is part of an internal code used to record formulations or research projects and the numbers indicate consecutive of the molecule under study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double Blind, Phase II Multicenter Trial to Evaluate the Safety and Efficacy of PRO-157 Ophthalmic Solution in Three Different Dosing Regimen Versus Moxifloxacin Versus Gatifloxacin in Patients With Bacterial Conjunctivitis.
• Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PRO-157 BID (2 times per day) 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)	Drug: PRO-157; PRO-157 (Pazufloxacin 0.06%) Laboratories Sophia S.A. de C.V., ophthalmic solution; Other Names: Pazufloxacin 0.06%, ophthalmic solution ; Drug: Lagricel Ofteno®; Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution; Other Names: Sodium hyaluronate 0.4%
Experimental: PRO-157 TID (3 times per day) 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)	Drug: PRO-157; PRO-157 (Pazufloxacin 0.06%) Laboratories Sophia S.A. de C.V., ophthalmic solution; Other Names: Pazufloxacin 0.06%, ophthalmic solution ; Drug: Lagricel Ofteno®; Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution; Other Names: Sodium hyaluronate 0.4%
Experimental: PRO-157 QID (4 times per day) 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157)	Drug: PRO-157; PRO-157 (Pazufloxacin 0.06%) Laboratories Sophia S.A. de C.V., ophthalmic solution; Other Names: Pazufloxacin 0.06%, ophthalmic solution ; Drug: Lagricel Ofteno®; Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution; Other Names: Sodium hyaluronate 0.4%
Active Comparator: Moxifloxacin (Vigamox®) 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin)	Drug: Vigamox; Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution; Other Names: Moxifloxacin ; Drug: Lagricel Ofteno®; Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution; Other Names: Sodium hyaluronate 0.4%
Active Comparator: Gatifloxacin (Zymar®) 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin)	Drug: Zymar®; Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution; Other Names: Gatifloxacin ; Drug: Lagricel Ofteno®; Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution; Other Names: Sodium hyaluronate 0.4%

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Obtained from physician office visit.

• Diagnosis of bacterial conjunctivitis (signs and / or symptoms and / or culture).

• Informed Consent signed and dated (consent of the parents for minor patients).

Exclusion Criteria:

• absence of written informed consent.

• Women of childbearing age, without contraceptive use (oral contraceptive pill, contraceptive intrauterine device, contraceptive implant, patch or condom).

• Pregnant or breastfeeding women.

• Subjects that could not be evaluated partially or totally according to the protocol.

• Subjects with topical, systemic or intravenous medication with any type of antibiotic on the day of the baseline visit.

• Subjects with topical, systemic or intravenous medication with any type of medication that interferes decisively with the results of the study.

• Subjects with a hypersensitivity history to any component or analogues of the formulation product.

• Positive drug addiction (smoking, alcoholism, marijuana).

• Subjects with a history of participation in any clinical study in the last 40 days prior to their evaluation.

• incapacity to give informed consent owing to mental disorder or legal condition.

• Any major anomaly detected during the clinical examination, tests that could interfere with the performance of the study or with the efficacy and safety evaluations.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unidad Medica "Grupo Pediátrico"	Guadalajara	Jalisco	Mexico	44690

Sponsors and Collaborators

• Laboratorios Sophia S.A de C.V.

Investigators

• Study Director: Leopoldo Baiza, MD, Laboratorios Sophia

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 1, 2016

More Information

Publications

None provided.

• Responsible Party: Laboratorios Sophia S.A de C.V.
• ClinicalTrials.gov Identifier: NCT02980523
• Other Study ID Numbers: SOPH157-0114/II
• First Posted: Dec 2, 2016
• Last Update Posted: May 22, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis; Moxifloxacin; Gatifloxacin; Pazufloxacin; Ophthalmic Solutions; Hyaluronic Acid

Study Results

Participant Flow

Arm/Group Title	PRO-157 BID (2 Times Per Day)	PRO-157 TID (3 Times Per Day)	PRO-157 QID (4 Times Per Day)	Moxifloxacin (Vigamox®)	Gatifloxacin (Zymar®)
Arm/Group Description	60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin) Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin) Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution
Period Title: Overall Study
STARTED	30	30	30	30	30
COMPLETED	27	19	24	21	20
NOT COMPLETED	3	11	6	9	10

Baseline Characteristics

Arm/Group Title	PRO-157 BID	PRO-157 TID	PRO-157 QID	Moxifloxacine	Gatifloxacine	Total
Arm/Group Description	One drop twice a day for 7 days (PRO-157=pazufloxacin 0.6%)	One drop three times a day for 7 days (PRO-157=pazufloxacin 0.6%)	One drop three times a day for 7 days (PRO-157=pazufloxacin 0.6%)	One drop four times a day for 7 days Moxifloxacin 0.5% (Vigamox®).	One drop four times a day for 7 days Gatifloxacin 0.3% (Zymar®).	Total of all reporting groups
Overall Participants	27	19	24	21	20	111
Overall eyes	54	38	48	42	40	222
Age (Count of Participants)
<=18 years	7 25.9%	3 15.8%	7 29.2%	5 23.8%	5 25%	27 24.3%
Between 18 and 65 years	11 40.7%	13 68.4%	10 41.7%	11 52.4%	8 40%	53 47.7%
>=65 years	9 33.3%	3 15.8%	7 29.2%	5 23.8%	7 35%	31 27.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.1 (27.9)	37.2 (21.3)	43.3 (25.7)	39.9 (26.9)	43.4 (29.5)	40.8 (26.2)
Sex: Female, Male (Count of Participants)
Female	19 70.4%	10 52.6%	16 66.7%	13 61.9%	11 55%	69 62.2%
Male	8 29.6%	9 47.4%	8 33.3%	8 38.1%	9 45%	42 37.8%
Region of Enrollment (Count of Participants)
Mexicans	27 100%	19 100%	24 100%	21 100%	20 100%	111 100%
others	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline Bacterial Culture
Description	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.
Time Frame	up to one week

Outcome Measure Data

Analysis Population Description

Treatment analysis, a culture was performed per eye

Arm/Group Title	PRO-157 BID (2 Times Per Day)	PRO-157 TID (3 Times Per Day)	PRO-157 QID (4 Times Per Day)	Moxifloxacin (Vigamox®)	Gatifloxacin (Zymar®)
Arm/Group Description	60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin) Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin) Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution
Measure Participants	15	8	13	15	9
Measure cultures	30	16	26	29	17
basal cultures positives	30	16	26	29	17
final cultures negatives	17	14	16	28	15

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PRO-157 BID (2 Times Per Day), PRO-157 TID (3 Times Per Day), PRO-157 QID (4 Times Per Day), Moxifloxacin (Vigamox®), Gatifloxacin (Zymar®)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Chi-squared
	Comments

2. Primary Outcome

Title	Adverse Events
Description	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.
Time Frame	during the intervention period for 7 days, and 15 days after the final visit

Outcome Measure Data

Analysis Population Description

Treatment analysis

Arm/Group Title	PRO-157 BID (2 Times Per Day)	PRO-157 TID (3 Times Per Day)	PRO-157 QID (4 Times Per Day)	Moxifloxacin (Vigamox®)	Gatifloxacin (Zymar®)
Arm/Group Description	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin) Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin) Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution
Measure Participants	27	19	24	21	20
Measure eyes	54	38	48	42	40
Number [events]	7	5	7	4	7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PRO-157 BID (2 Times Per Day), PRO-157 TID (3 Times Per Day), PRO-157 QID (4 Times Per Day), Moxifloxacin (Vigamox®), Gatifloxacin (Zymar®)
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.
Statistical Test of Hypothesis	p-Value	0.372
	Comments
	Method	Chi-squared, Corrected
	Comments

3. Secondary Outcome

Title	Cases Frequency of Ocular Secretion
Description	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.
Time Frame	Up to one week.

Outcome Measure Data

Analysis Population Description

treatment analysis.

Arm/Group Title	PRO-157 BID (2 Times Per Day)	PRO-157 TID (3 Times Per Day)	PRO-157 QID (4 Times Per Day)	Moxifloxacin (Vigamox®)	Gatifloxacin (Zymar®)
Arm/Group Description	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin) Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin) Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution
Measure Participants	27	19	24	21	20
Measure eyes	54	38	48	42	40
Number [secretion cases reported]	0	3	0	7	2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PRO-157 BID (2 Times Per Day), PRO-157 TID (3 Times Per Day), PRO-157 QID (4 Times Per Day), Moxifloxacin (Vigamox®), Gatifloxacin (Zymar®)
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.
Statistical Test of Hypothesis	p-Value	0.341
	Comments
	Method	Chi-squared, Corrected
	Comments

4. Secondary Outcome

Title	Number of Cases of Conjunctival Hyperemia
Description	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.
Time Frame	up to one week

Outcome Measure Data

Analysis Population Description

Treatment analysis

Arm/Group Title	PRO-157 BID (2 Times Per Day)	PRO-157 TID (3 Times Per Day)	PRO-157 QID (4 Times Per Day)	Moxifloxacin (Vigamox®)	Gatifloxacin (Zymar®)
Arm/Group Description	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin) Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin) Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution
Measure Participants	27	19	24	21	20
Measure eyes	54	38	48	42	40
Number [hyperemia cases reported]	17	1	5	7	8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PRO-157 BID (2 Times Per Day), PRO-157 TID (3 Times Per Day), PRO-157 QID (4 Times Per Day), Moxifloxacin (Vigamox®), Gatifloxacin (Zymar®)
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Chi-squared, Corrected
	Comments

5. Secondary Outcome

Title	Chemosis Frequency
Description	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.
Time Frame	up to one week

Outcome Measure Data

Analysis Population Description

Treatment analysis

Arm/Group Title	PRO-157 BID (2 Times Per Day)	PRO-157 TID (3 Times Per Day)	PRO-157 QID (4 Times Per Day)	Moxifloxacin (Vigamox®)	Gatifloxacin (Zymar®)
Arm/Group Description	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin) Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin) Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution
Measure Participants	27	19	24	21	20
Measure eyes	54	38	48	42	40
Number [chemosis cases reported]	0	0	0	6	2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PRO-157 BID (2 Times Per Day), PRO-157 TID (3 Times Per Day), PRO-157 QID (4 Times Per Day), Moxifloxacin (Vigamox®), Gatifloxacin (Zymar®)
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Chi-squared, Corrected
	Comments

6. Secondary Outcome

Title	Eyelid Edema Frequency
Description	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.
Time Frame	Up to one week

Outcome Measure Data

Analysis Population Description

Treatment analysis

Arm/Group Title	PRO-157 BID (2 Times Per Day)	PRO-157 TID (3 Times Per Day)	PRO-157 QID (4 Times Per Day)	Moxifloxacin (Vigamox®)	Gatifloxacin (Zymar®)
Arm/Group Description	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin) Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin) Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution
Measure Participants	27	19	24	21	20
Measure eyes	54	38	48	42	40
Number [eyelid edema cases reported]	6	0	4	4	6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PRO-157 BID (2 Times Per Day), PRO-157 TID (3 Times Per Day), PRO-157 QID (4 Times Per Day), Moxifloxacin (Vigamox®), Gatifloxacin (Zymar®)
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.
Statistical Test of Hypothesis	p-Value	0.216
	Comments
	Method	Chi-squared, Corrected
	Comments

7. Secondary Outcome

Title	Frequency of Corneal Epithelial Defects
Description	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.
Time Frame	Up to one week

Outcome Measure Data

Analysis Population Description

Treatment analysis

Arm/Group Title	PRO-157 BID (2 Times Per Day)	PRO-157 TID (3 Times Per Day)	PRO-157 QID (4 Times Per Day)	Moxifloxacin (Vigamox®)	Gatifloxacin (Zymar®)
Arm/Group Description	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin) Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin) Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution
Measure Participants	27	19	24	21	20
Measure eyes	54	38	48	42	40
Number [Corneal defects cases reported]	9	4	6	5	5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PRO-157 BID (2 Times Per Day), PRO-157 TID (3 Times Per Day), PRO-157 QID (4 Times Per Day), Moxifloxacin (Vigamox®), Gatifloxacin (Zymar®)
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	The aim of this study was to find the ideal dose of treatment for bacterial eradication and non-inferiority with the comparative groups.
Statistical Test of Hypothesis	p-Value	0.829
	Comments
	Method	Chi-squared, Corrected
	Comments

Adverse Events

Time Frame	Adverse events were monitored during the intervention period for 8 days, and a follow-up call was made 15 days after the final visit.
Adverse Event Reporting Description	Adverse events were recorded according to the patient's scheduled or unscheduled visits, and were given a diary in which they could make annotations of their symptoms, the investigator reviewed these symptoms and reported on them The format of adverse events.
Arm/Group Title	PRO-157 BID (2 Times Per Day)		PRO-157 TID (3 Times Per Day)		PRO-157 QID (4 Times Per Day)		Moxifloxacin (Vigamox®)		Gatifloxacin (Zymar®)
Arm/Group Description	60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%)every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution		60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution		60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day, for 7 days. (Can be applied 15 minutes after PRO 157) PRO-157: PRO-157 (Pazufloxacin 0.09%) Laboratories Sophia S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution		60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days. (Can be applied 15 minutes after moxifloxacin) Vigamox: Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution		60 eyes will be evaluated with the following therapeutic regimen: instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 15 minutes after, instill one drop in each eye of Lagricel Ofteno® (Sodium hyaluronate 0.4%) every 6 hours per day for 7 days.one drop 4 times a day for 7 days in each eye.(Can be applied 15 minutes after gatifloxacin) Zymar®: Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution Lagricel Ofteno®: Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution
All Cause Mortality
	PRO-157 BID (2 Times Per Day)		PRO-157 TID (3 Times Per Day)		PRO-157 QID (4 Times Per Day)		Moxifloxacin (Vigamox®)		Gatifloxacin (Zymar®)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	PRO-157 BID (2 Times Per Day)		PRO-157 TID (3 Times Per Day)		PRO-157 QID (4 Times Per Day)		Moxifloxacin (Vigamox®)		Gatifloxacin (Zymar®)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)		0/30 (0%)		1/30 (3.3%)		1/30 (3.3%)
Eye disorders
ischemic optic neuropathy	0/30 (0%)	0	0/30 (0%)	0	0/30 (0%)	0	0/30 (0%)	0	1/30 (3.3%)	1
Renal and urinary disorders
urinary tract infection (ITU)	0/30 (0%)	0	0/30 (0%)	0	0/30 (0%)	0	1/30 (3.3%)	1	0/30 (0%)	0
Other (Not Including Serious) Adverse Events
	PRO-157 BID (2 Times Per Day)		PRO-157 TID (3 Times Per Day)		PRO-157 QID (4 Times Per Day)		Moxifloxacin (Vigamox®)		Gatifloxacin (Zymar®)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/30 (23.3%)		5/30 (16.7%)		7/30 (23.3%)		3/30 (10%)		6/30 (20%)
Ear and labyrinth disorders
Tinnitus	0/30 (0%)	0	1/30 (3.3%)	1	0/30 (0%)	0	0/30 (0%)	0	1/30 (3.3%)	1
Eye disorders
Eyelid ecchymosis	0/30 (0%)	0	1/30 (3.3%)	1	0/30 (0%)	0	0/30 (0%)	0	0/30 (0%)	0
hordeolum	0/30 (0%)	0	0/30 (0%)	0	1/30 (3.3%)	1	0/30 (0%)	0	0/30 (0%)	0
eye pain	1/30 (3.3%)	1	0/30 (0%)	0	0/30 (0%)	0	0/30 (0%)	0	0/30 (0%)	0
Numular keratitis	2/30 (6.7%)	2	0/30 (0%)	0	0/30 (0%)	0	0/30 (0%)	0	2/30 (6.7%)	2
Irritant conjunctivitis	0/30 (0%)	0	0/30 (0%)	0	0/30 (0%)	0	1/30 (3.3%)	1	0/30 (0%)	0
Preseptal cellulitis	0/30 (0%)	0	0/30 (0%)	0	0/30 (0%)	0	0/30 (0%)	0	1/30 (3.3%)	1
Gastrointestinal disorders
stomach flu	0/30 (0%)	0	1/30 (3.3%)	1	0/30 (0%)	0	0/30 (0%)	0	0/30 (0%)	0
Dysgeusia	1/30 (3.3%)	1	0/30 (0%)	0	1/30 (3.3%)	1	1/30 (3.3%)	1	0/30 (0%)	0
gastritis	1/30 (3.3%)	1	0/30 (0%)	0	0/30 (0%)	0	0/30 (0%)	0	0/30 (0%)	0
constipation	0/30 (0%)	0	0/30 (0%)	0	1/30 (3.3%)	1	0/30 (0%)	0	0/30 (0%)	0
stomachache	0/30 (0%)	0	0/30 (0%)	0	0/30 (0%)	0	1/30 (3.3%)	1	0/30 (0%)	0
General disorders
Lack of effectiveness	0/30 (0%)	0	0/30 (0%)	0	3/30 (10%)	3	0/30 (0%)	0	1/30 (3.3%)	1
Infections and infestations
Pharyngotonsillitis	0/30 (0%)	0	1/30 (3.3%)	1	0/30 (0%)	0	0/30 (0%)	0	0/30 (0%)	0
Nervous system disorders
dizziness	1/30 (3.3%)	1	0/30 (0%)	0	0/30 (0%)	0	0/30 (0%)	0	0/30 (0%)	0
Headache	1/30 (3.3%)	1	1/30 (3.3%)	1	1/30 (3.3%)	1	0/30 (0%)	0	0/30 (0%)	0
Vascular disorders
Systemic hypertension	0/30 (0%)	0	0/30 (0%)	0	0/30 (0%)	0	0/30 (0%)	0	1/30 (3.3%)	1

Limitations/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.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

PI (s) can not make use of the partial or total information of this investigation, due to the clauses contained in the agreement of confidentiality of the study.