Trial Outcomes & Findings for Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin) (NCT NCT02980523)

NCT ID: NCT02980523

Last Updated: 2019-05-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 150 participants
• Primary outcome timeframe: up to one week
• Results posted on: 2019-05-22

Participant Flow

Unit of analysis: eyes

Participant milestones

Measure	PRO-157 BID (2 Times Per Day) 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days 2. 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	PRO-157 TID (3 Times Per Day) 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 2. 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	PRO-157 QID (4 Times Per Day) 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 2. 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	Moxifloxacin (Vigamox®) 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 2. 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	Gatifloxacin (Zymar®) 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 2. 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
Overall Study STARTED	30 60	30 60	30 60	30 60	30 60
Overall Study COMPLETED	27 54	19 38	24 48	21 42	20 40
Overall Study NOT COMPLETED	3 6	11 22	6 12	9 18	10 20

Reasons for withdrawal

Measure	PRO-157 BID (2 Times Per Day) 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days 2. 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	PRO-157 TID (3 Times Per Day) 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 2. 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	PRO-157 QID (4 Times Per Day) 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 2. 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	Moxifloxacin (Vigamox®) 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 2. 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	Gatifloxacin (Zymar®) 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 2. 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
Overall Study Lost to Follow-up	1	4	1	2	1
Overall Study Excluded from analysis	1	3	1	1	1
Overall Study Lack of Efficacy	1	4	4	5	8
Overall Study Did not receive intervention	0	0	0	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	PRO-157 BID n=54 eyes One drop twice a day for 7 days (PRO-157=pazufloxacin 0.6%)	PRO-157 TID n=38 eyes One drop three times a day for 7 days (PRO-157=pazufloxacin 0.6%)	PRO-157 QID n=48 eyes One drop three times a day for 7 days (PRO-157=pazufloxacin 0.6%)	Moxifloxacine n=42 eyes One drop four times a day for 7 days Moxifloxacin 0.5% (Vigamox®).	Gatifloxacine n=40 eyes One drop four times a day for 7 days Gatifloxacin 0.3% (Zymar®).	Total n=222 eyes Total of all reporting groups
Age, Categorical <=18 years	7 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	27 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	11 Participants n=4 Participants	8 Participants n=21 Participants	53 Participants n=8 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	5 Participants n=4 Participants	7 Participants n=21 Participants	31 Participants n=8 Participants
Age, Continuous	41.1 years STANDARD_DEVIATION 27.9 • n=5 Participants	37.2 years STANDARD_DEVIATION 21.3 • n=7 Participants	43.3 years STANDARD_DEVIATION 25.7 • n=5 Participants	39.9 years STANDARD_DEVIATION 26.9 • n=4 Participants	43.4 years STANDARD_DEVIATION 29.5 • n=21 Participants	40.8 years STANDARD_DEVIATION 26.2 • n=8 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants	13 Participants n=4 Participants	11 Participants n=21 Participants	69 Participants n=8 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	9 Participants n=21 Participants	42 Participants n=8 Participants
Region of Enrollment Mexico · Mexicans	27 Participants n=5 Participants	19 Participants n=7 Participants	24 Participants n=5 Participants	21 Participants n=4 Participants	20 Participants n=21 Participants	111 Participants n=8 Participants
Region of Enrollment Mexico · others	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants

PRIMARY outcome

Timeframe: up to one week

Population: Treatment analysis, a culture was performed per eye

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.

Outcome measures

Measure	PRO-157 BID (2 Times Per Day) n=30 cultures 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days 2. 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	PRO-157 TID (3 Times Per Day) n=16 cultures 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 2. 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	PRO-157 QID (4 Times Per Day) n=26 cultures 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 2. 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	Moxifloxacin (Vigamox®) n=29 cultures 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 2. 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	Gatifloxacin (Zymar®) n=17 cultures 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 2. 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
Change From Baseline Bacterial Culture basal cultures positives	30 cultures	16 cultures	26 cultures	29 cultures	17 cultures
Change From Baseline Bacterial Culture final cultures negatives	17 cultures	14 cultures	16 cultures	28 cultures	15 cultures

PRIMARY outcome

Timeframe: during the intervention period for 7 days, and 15 days after the final visit

Population: Treatment analysis

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.

Outcome measures

Measure	PRO-157 BID (2 Times Per Day) n=54 eyes 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days 2. 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	PRO-157 TID (3 Times Per Day) n=38 eyes 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 2. 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	PRO-157 QID (4 Times Per Day) n=48 eyes 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 2. 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	Moxifloxacin (Vigamox®) n=42 eyes 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 2. 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	Gatifloxacin (Zymar®) n=40 eyes 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 2. 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
Adverse Events	7 events	5 events	7 events	4 events	7 events

SECONDARY outcome

Timeframe: Up to one week.

Population: treatment analysis.

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.

Outcome measures

Measure	PRO-157 BID (2 Times Per Day) n=54 eyes 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days 2. 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	PRO-157 TID (3 Times Per Day) n=38 eyes 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 2. 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	PRO-157 QID (4 Times Per Day) n=48 eyes 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 2. 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	Moxifloxacin (Vigamox®) n=42 eyes 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 2. 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	Gatifloxacin (Zymar®) n=40 eyes 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 2. 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
Cases Frequency of Ocular Secretion	0 secretion cases reported	3 secretion cases reported	0 secretion cases reported	7 secretion cases reported	2 secretion cases reported

SECONDARY outcome

Timeframe: up to one week

Population: Treatment analysis

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.

Outcome measures

Measure	PRO-157 BID (2 Times Per Day) n=54 eyes 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days 2. 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	PRO-157 TID (3 Times Per Day) n=38 eyes 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 2. 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	PRO-157 QID (4 Times Per Day) n=48 eyes 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 2. 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	Moxifloxacin (Vigamox®) n=42 eyes 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 2. 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	Gatifloxacin (Zymar®) n=40 eyes 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 2. 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
Number of Cases of Conjunctival Hyperemia	17 hyperemia cases reported	1 hyperemia cases reported	5 hyperemia cases reported	7 hyperemia cases reported	8 hyperemia cases reported

SECONDARY outcome

Timeframe: up to one week

Population: Treatment analysis

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.

Outcome measures

Measure	PRO-157 BID (2 Times Per Day) n=54 eyes 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days 2. 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	PRO-157 TID (3 Times Per Day) n=38 eyes 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 2. 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	PRO-157 QID (4 Times Per Day) n=48 eyes 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 2. 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	Moxifloxacin (Vigamox®) n=42 eyes 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 2. 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	Gatifloxacin (Zymar®) n=40 eyes 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 2. 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
Chemosis Frequency	0 chemosis cases reported	0 chemosis cases reported	0 chemosis cases reported	6 chemosis cases reported	2 chemosis cases reported

SECONDARY outcome

Timeframe: Up to one week

Population: Treatment analysis

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.

Outcome measures

Measure	PRO-157 BID (2 Times Per Day) n=54 eyes 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days 2. 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	PRO-157 TID (3 Times Per Day) n=38 eyes 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 2. 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	PRO-157 QID (4 Times Per Day) n=48 eyes 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 2. 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	Moxifloxacin (Vigamox®) n=42 eyes 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 2. 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	Gatifloxacin (Zymar®) n=40 eyes 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 2. 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
Eyelid Edema Frequency	6 eyelid edema cases reported	0 eyelid edema cases reported	4 eyelid edema cases reported	4 eyelid edema cases reported	6 eyelid edema cases reported

SECONDARY outcome

Timeframe: Up to one week

Population: Treatment analysis

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.

Outcome measures

Measure	PRO-157 BID (2 Times Per Day) n=54 eyes 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days 2. 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	PRO-157 TID (3 Times Per Day) n=38 eyes 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 2. 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	PRO-157 QID (4 Times Per Day) n=48 eyes 60 eyes of 30 research subjects will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 2. 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	Moxifloxacin (Vigamox®) n=42 eyes 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 2. 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	Gatifloxacin (Zymar®) n=40 eyes 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 2. 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
Frequency of Corneal Epithelial Defects	9 Corneal defects cases reported	4 Corneal defects cases reported	6 Corneal defects cases reported	5 Corneal defects cases reported	5 Corneal defects cases reported

Adverse Events

PRO-157 BID (2 Times Per Day)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

PRO-157 TID (3 Times Per Day)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

PRO-157 QID (4 Times Per Day)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Moxifloxacin (Vigamox®)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Gatifloxacin (Zymar®)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	PRO-157 BID (2 Times Per Day) n=30 participants at risk 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days 2. 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	PRO-157 TID (3 Times Per Day) n=30 participants at risk 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 2. 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	PRO-157 QID (4 Times Per Day) n=30 participants at risk 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 2. 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	Moxifloxacin (Vigamox®) n=30 participants at risk 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 2. 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	Gatifloxacin (Zymar®) n=30 participants at risk 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 2. 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
Renal and urinary disorders urinary tract infection (ITU)	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	3.3% 1/30 • Number of events 1 • 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 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.	0.00% 0/30 • 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 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.
Eye disorders ischemic optic neuropathy	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	3.3% 1/30 • Number of events 1 • 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 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.

Other adverse events

Measure	PRO-157 BID (2 Times Per Day) n=30 participants at risk 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 12 hours per day (BID), for 7 days 2. 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	PRO-157 TID (3 Times Per Day) n=30 participants at risk 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 8 hours per day (TID), for 7 days 2. 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	PRO-157 QID (4 Times Per Day) n=30 participants at risk 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of PRO-157 (pazufloxacin), every 6 hours per day (QID), for 7 days 2. 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	Moxifloxacin (Vigamox®) n=30 participants at risk 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Moxifloxacin, every 8 hours per day, for 7 days. 2. 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	Gatifloxacin (Zymar®) n=30 participants at risk 60 eyes will be evaluated with the following therapeutic regimen: 1. instill one drop in each eye of Gatifloxacin, every 8 hours per day, for 7 days. 2. 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
Eye disorders Eyelid ecchymosis	0.00% 0/30 • 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 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.	3.3% 1/30 • Number of events 1 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.
Gastrointestinal disorders stomach flu	0.00% 0/30 • 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 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.	3.3% 1/30 • Number of events 1 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.
Eye disorders hordeolum	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	3.3% 1/30 • Number of events 1 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.
Gastrointestinal disorders Dysgeusia	3.3% 1/30 • Number of events 1 • 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 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.	0.00% 0/30 • 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 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.	3.3% 1/30 • Number of events 1 • 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 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.	3.3% 1/30 • Number of events 1 • 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 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.	0.00% 0/30 • 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 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.
Eye disorders eye pain	3.3% 1/30 • Number of events 1 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.
Nervous system disorders dizziness	3.3% 1/30 • Number of events 1 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.
Nervous system disorders Headache	3.3% 1/30 • Number of events 1 • 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 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.	3.3% 1/30 • Number of events 1 • 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 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.	3.3% 1/30 • Number of events 1 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.
Eye disorders Numular keratitis	6.7% 2/30 • Number of events 2 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	6.7% 2/30 • Number of events 2 • 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 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.
Gastrointestinal disorders gastritis	3.3% 1/30 • Number of events 1 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.
General disorders Lack of effectiveness	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	10.0% 3/30 • Number of events 3 • 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 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.	0.00% 0/30 • 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 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.	3.3% 1/30 • Number of events 1 • 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 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.
Gastrointestinal disorders constipation	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	3.3% 1/30 • Number of events 1 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.
Eye disorders Irritant conjunctivitis	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	3.3% 1/30 • Number of events 1 • 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 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.	0.00% 0/30 • 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 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.
Ear and labyrinth disorders Tinnitus	0.00% 0/30 • 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 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.	3.3% 1/30 • Number of events 1 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	3.3% 1/30 • Number of events 1 • 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 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.
Vascular disorders Systemic hypertension	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	3.3% 1/30 • Number of events 1 • 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 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.
Infections and infestations Pharyngotonsillitis	0.00% 0/30 • 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 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.	3.3% 1/30 • Number of events 1 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.
Eye disorders Preseptal cellulitis	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	3.3% 1/30 • Number of events 1 • 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 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.
Gastrointestinal disorders stomachache	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	0.00% 0/30 • 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 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.	3.3% 1/30 • Number of events 1 • 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 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.	0.00% 0/30 • 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 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.

Additional Information

Clinical pharmacologist

Laboratorios Sophia

Phone: +52 (33) 3001 4200

Email: ricardo.llamas@sophia.com.mx

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER