A Phase 2 interventional study of PRO-157 and Vigamox in Bacterial Conjunctivitis, sponsored by Laboratorios Sophia S.A de C.V.. Completed at 1 site in Mexico. Open to participants aged 1 Day to 99 Years. Per ClinicalTrials.gov, last updated 2019-05-22.
Sponsored by Laboratorios Sophia S.A de C.V. · Phase 2, Interventional, and Treatment
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:
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.
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.
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 150 is below the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.
Browse Conjunctivitis, Bacterial studies →Laboratorios Sophia S.A de C.V. is the lead sponsor of 45 studies on the registry; 5 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Drug: PRO-157 · Drug: Lagricel Ofteno®
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)
Drug: PRO-157 · Drug: Lagricel Ofteno®
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)
Drug: PRO-157 · Drug: Lagricel Ofteno®
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)
Drug: Vigamox · Drug: Lagricel Ofteno®
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)
Drug: Zymar® · Drug: Lagricel Ofteno®
PRO-157 (Pazufloxacin 0.06%) Laboratories Sophia S.A. de C.V., ophthalmic solution
Also known as: Pazufloxacin 0.06%, ophthalmic solution
Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution
Also known as: Moxifloxacin
Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution
Also known as: Gatifloxacin
Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution
Also known as: Sodium hyaluronate 0.4%
Change From Baseline Bacterial Culture
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
Adverse Events
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
Cases Frequency of Ocular Secretion
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.
Number of Cases of Conjunctival Hyperemia
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
Chemosis Frequency
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
Eyelid Edema Frequency
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
Frequency of Corneal Epithelial Defects
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
| Milestone | 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®) |
|---|---|---|---|---|---|
| Started | 30 | 30 | 30 | 30 | 30 |
| Completed | 27 | 19 | 24 | 21 | 20 |
| Not completed | 3 | 11 | 6 | 9 | 10 |
| Withdrew: Lost to follow-up | 1 | 4 | 1 | 2 | 1 |
| Withdrew: Excluded from analysis | 1 | 3 | 1 | 1 | 1 |
| Withdrew: Lack of efficacy | 1 | 4 | 4 | 5 | 8 |
| Withdrew: Did not receive intervention | 0 | 0 | 0 | 1 | 0 |
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.
| cultures | 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®) |
|---|---|---|---|---|---|
| basal cultures positives | 30 | 16 | 26 | 29 | 17 |
| final cultures negatives | 17 | 14 | 16 | 28 | 15 |
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.
| 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®) |
|---|---|---|---|---|---|
| Adverse Events | 7 | 5 | 7 | 4 | 7 |
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.
| secretion cases reported | 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®) |
|---|---|---|---|---|---|
| Cases Frequency of Ocular Secretion | 0 | 3 | 0 | 7 | 2 |
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.
| hyperemia cases reported | 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®) |
|---|---|---|---|---|---|
| Number of Cases of Conjunctival Hyperemia | 17 | 1 | 5 | 7 | 8 |
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.
| chemosis cases reported | 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®) |
|---|---|---|---|---|---|
| Chemosis Frequency | 0 | 0 | 0 | 6 | 2 |
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.
| eyelid edema cases reported | 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®) |
|---|---|---|---|---|---|
| Eyelid Edema Frequency | 6 | 0 | 4 | 4 | 6 |
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.
| Corneal defects cases reported | 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®) |
|---|---|---|---|---|---|
| Frequency of Corneal Epithelial Defects | 9 | 4 | 6 | 5 | 5 |
Collected over Adverse events were monitored during the intervention period for 8 days, and a follow-up call was made 15 days after the final visit.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PRO-157 BID (2 Times Per Day) | — | 0/30 (0%) | 7/30 (23.3%) |
| PRO-157 TID (3 Times Per Day) | — | 0/30 (0%) | 5/30 (16.7%) |
| PRO-157 QID (4 Times Per Day) | — | 0/30 (0%) | 7/30 (23.3%) |
| Moxifloxacin (Vigamox®) | — | 1/30 (3.3%) | 3/30 (10%) |
| Gatifloxacin (Zymar®) | — | 1/30 (3.3%) | 6/30 (20%) |
| Event | 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®) |
|---|---|---|---|---|---|
| urinary tract infection (ITU)Renal and urinary disorders | 0/30 | 0/30 | 0/30 | 1/30 | 0/30 |
| ischemic optic neuropathyEye disorders | 0/30 | 0/30 | 0/30 | 0/30 | 1/30 |
| Event | 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®) |
|---|---|---|---|---|---|
| Lack of effectivenessGeneral disorders | 0/30 | 0/30 | 3/30 | 0/30 | 1/30 |
| Numular keratitisEye disorders | 2/30 | 0/30 | 0/30 | 0/30 | 2/30 |
| Eyelid ecchymosisEye disorders | 0/30 | 1/30 | 0/30 | 0/30 | 0/30 |
| stomach fluGastrointestinal disorders | 0/30 | 1/30 | 0/30 | 0/30 | 0/30 |
| hordeolumEye disorders | 0/30 | 0/30 | 1/30 | 0/30 | 0/30 |
| DysgeusiaGastrointestinal disorders | 1/30 | 0/30 | 1/30 | 1/30 | 0/30 |
| eye painEye disorders | 1/30 | 0/30 | 0/30 | 0/30 | 0/30 |
| dizzinessNervous system disorders | 1/30 | 0/30 | 0/30 | 0/30 | 0/30 |
| HeadacheNervous system disorders | 1/30 | 1/30 | 1/30 | 0/30 | 0/30 |
| gastritisGastrointestinal disorders | 1/30 | 0/30 | 0/30 | 0/30 | 0/30 |
| Age, Categorical(Participants) | PRO-157 BID | PRO-157 TID | PRO-157 QID | Moxifloxacine | Gatifloxacine | Total |
|---|---|---|---|---|---|---|
| <=18 years | 7 | 3 | 7 | 5 | 5 | 27 |
| Between 18 and 65 years | 11 | 13 | 10 | 11 | 8 | 53 |
| >=65 years | 9 | 3 | 7 | 5 | 7 | 31 |
| Age, Continuous(years) | PRO-157 BID | PRO-157 TID | PRO-157 QID | Moxifloxacine | Gatifloxacine | Total |
|---|---|---|---|---|---|---|
| Mean | 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(Participants) | PRO-157 BID | PRO-157 TID | PRO-157 QID | Moxifloxacine | Gatifloxacine | Total |
|---|---|---|---|---|---|---|
| Female | 19 | 10 | 16 | 13 | 11 | 69 |
| Male | 8 | 9 | 8 | 8 | 9 | 42 |
| Region of Enrollment(Participants) | PRO-157 BID | PRO-157 TID | PRO-157 QID | Moxifloxacine | Gatifloxacine | Total |
|---|---|---|---|---|---|---|
| Mexico — Mexicans | 27 | 19 | 24 | 21 | 20 | 111 |
| Mexico — others | 0 | 0 | 0 | 0 | 0 | 0 |
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