Bacterial ConjunctivitisPhase 2PazufloxacinNCT02980523
Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin)
A Phase 2 study testing PRO-157, Vigamox and Zymar® in people with Bacterial Conjunctivitis, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
Trial summary
A randomized, double blind, phase II multicenter trial with the objective of assess the safety and efficacy of the PRO-157 ophthalmic solution in three different dosing regimens, versus Moxifloxacin, versus Gatifloxacin in patients with bacterial conjunctivitis. Number of participants: 300 eyes, 60 per group. Read more about this study
- Who is it for?
- Ages 1 day to 99 years
- Conditions the study is for
- Bacterial Conjunctivitis
- What is being tested?
- PRO-157, Vigamox and Zymar®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteMexico
- Study dates
- Mar 2015to May 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Obtained from physician office visit.
- Diagnosis of bacterial conjunctivitis (signs and / or symptoms and / or culture).
- Informed Consent signed and dated (consent of the parents for minor patients).
Who cannot join
- absence of written informed consent.
- Women of childbearing age, without contraceptive use (oral contraceptive pill, contraceptive intrauterine device, contraceptive implant, patch or condom).
- Pregnant or breastfeeding women.
- Subjects that could not be evaluated partially or totally according to the protocol.
- Subjects with topical, systemic or intravenous medication with any type of antibiotic on the day of the baseline visit.
- Subjects with topical, systemic or intravenous medication with any type of medication that interferes decisively with the results of the study.
Show all 11Show fewer
- Subjects with a hypersensitivity history to any component or analogues of the formulation product.
- Positive drug addiction (smoking, alcoholism, marijuana).
- Subjects with a history of participation in any clinical study in the last 40 days prior to their evaluation.
- incapacity to give informed consent owing to mental disorder or legal condition.
- Any major anomaly detected during the clinical examination, tests that could interfere with the performance of the study or with the efficacy and safety evaluations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Phase II Multicenter Trial to Evaluate the Safety and Efficacy of PRO-157 Ophthalmic Solution in Three Different Dosing Regimen Versus Moxifloxacin Versus Gatifloxacin in Patients With Bacterial Conjunctivitis.
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.
Read more
Criteria for evaluation:
Measurements of effectiveness: Main efficacy criterion It will be determined as effective if there is a reduction in number or species of bacterial flora by comparing the basal culture against the final culture among the five different patient groups.
Reduction or absence of infection with the clinical evaluation through signs and symptoms.
Safety Measurements: it will be determined by visual acuity and adverse events Patients recruited will be treated for 7, for protocol purpose, the infected eye (s) will be taken into account at the time of baseline, however the study medication and procedures will be applied and performed in both eyes to protect the healthy eye.
The study is divided into the following evaluation periods:
Visit 1 baseline (day 1), visit 2 (day 3), final visit (day 8) and a telephone call (day 23) for the evaluation of adverse events.
Subjects will be allocated to any of the following regimen dosages:
- PRO-157 1 drop 2 times daily
- PRO-157 1 drop 3 times daily
- PRO-157 1 drop 4 times daily
- Moxifloxacin 1 drop 3 times daily
- Gatifloxacin 1 drop 3 times daily. All regimen dosage will have a duration of 7 days. An artificial tear preservative free (Lagricel Ofteno®) will also be applied 15 minutes before instillation of study drug, during study period.
Data Analysis: The data will be analyzed by Intention to Treat (ITT) and per Protocol (PP) in which each of the variables is described, the ITT population will be constituted by all subjects recruited who have received at least one dose of the study, the PP population will be the subset of ITT composed of all subjects without any major deviation from the protocol and the bivariate analysis will be performed in this group.
Continuous quantitative variables are expressed and presented by measures of central tendency and dispersion (mean, standard deviation and ranges). Qualitative nominal and ordinal variables are presented by means of frequencies and proportions. The level of significance was an alpha of 0.05 or less.
Read the detailed description
Lagricel Ofteno® is a registered trademark, therefore the use of the same throughout the document can not be translated into the English language.
PRO-157, the acronym is part of an internal code used to record formulations or research projects and the numbers indicate consecutive of the molecule under study.
- Conditions
- Bacterial Conjunctivitis
- Being tested
- PRO-157, Vigamox, Zymar®, Lagricel Ofteno®
- Medical subject headings
- Conjunctivitis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-157Drug
Also called Pazufloxacin 0.06%, ophthalmic solution
PRO-157 (Pazufloxacin 0.06%) Laboratories Sophia S.A. de C.V., ophthalmic solution
VigamoxDrug
Also called Moxifloxacin
Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution
Zymar®Drug
Also called Gatifloxacin
Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution
Lagricel Ofteno®Drug
Also called Sodium hyaluronate 0.4%
Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| PRO-157 BID (2 times per day) | Experimental | 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) Receives: Drug: PRO-157; Drug: Lagricel Ofteno® |
| PRO-157 TID (3 times per day) | Experimental | 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) Receives: Drug: PRO-157; Drug: Lagricel Ofteno® |
| PRO-157 QID (4 times per day) | Experimental | 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) Receives: Drug: PRO-157; Drug: Lagricel Ofteno® |
| Moxifloxacin (Vigamox®) | Active comparator | 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) Receives: Drug: Vigamox; Drug: Lagricel Ofteno® |
| Gatifloxacin (Zymar®) | Active comparator | 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) Receives: Drug: Zymar®; Drug: Lagricel Ofteno® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: during the intervention period for 7 days, and 15 days after the final visit
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bacterial ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratorios Sophia S.A de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leopoldo Baiza, MD, Study director, Laboratorios Sophia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980523
- Sponsor's protocol ID
- SOPH157-0114/II
- Acronym
- Pazufloxacin
- Status last verified
- May 2019
- First submitted
- 17 Nov 2016
- Last updated
- 22 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Phase II Multicenter Trial to Evaluate the Safety and Efficacy of PRO-157 Ophthalmic Solution in Three Different Dosing Regimen Versus Moxifloxacin Versus Gatifloxacin in Patients With Bacterial Conjunctivitis.
- ClinicalTrials.gov ID
- NCT02980523
- Acronym / sponsor ID
- Pazufloxacin / SOPH157-0114/II
- Conditions
- Bacterial Conjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Laboratorios Sophia S.A de C.V.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double blind, phase II multicenter trial with the objective of assess the safety and efficacy of the PRO-157 ophthalmic solution in three different dosing regimens, versus Moxifloxacin, versus Gatifloxacin in patients with bacterial conjunctivitis.
Number of participants: 300 eyes, 60 per group.
Criteria for evaluation:
Measurements of effectiveness: Main efficacy criterion It will be determined as effective if there is a reduction in number or species of bacterial flora by comparing the basal culture against the final culture among the five different patient groups.
Reduction or absence of infection with the clinical evaluation through signs and symptoms.
Safety Measurements: it will be determined by visual acuity and adverse events Patients recruited will be treated for 7, for protocol purpose, the infected eye (s) will be taken into account at the time of baseline, however the study medication and procedures will be applied and performed in both eyes to protect the healthy eye.
The study is divided into the following evaluation periods:
Visit 1 baseline (day 1), visit 2 (day 3), final visit (day 8) and a telephone call (day 23) for the evaluation of adverse events.
Subjects will be allocated to any of the following regimen dosages:
- PRO-157 1 drop 2 times daily
- PRO-157 1 drop 3 times daily
- PRO-157 1 drop 4 times daily
- Moxifloxacin 1 drop 3 times daily
- Gatifloxacin 1 drop 3 times daily. All regimen dosage will have a duration of 7 days. An artificial tear preservative free (Lagricel Ofteno®) will also be applied 15 minutes before instillation of study drug, during study period.
Data Analysis: The data will be analyzed by Intention to Treat (ITT) and per Protocol (PP) in which each of the variables is described, the ITT population will be constituted by all subjects recruited who have received at least one dose of the study, the PP population will be the subset of ITT composed of all subjects without any major deviation from the protocol and the bivariate analysis will be performed in this group.
Continuous quantitative variables are expressed and presented by measures of central tendency and dispersion (mean, standard deviation and ranges). Qualitative nominal and ordinal variables are presented by means of frequencies and proportions. The level of significance was an alpha of 0.05 or less.
Detailed description
Lagricel Ofteno® is a registered trademark, therefore the use of the same throughout the document can not be translated into the English language.
PRO-157, the acronym is part of an internal code used to record formulations or research projects and the numbers indicate consecutive of the molecule under study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PRO-157 BID (2 times per day) | Experimental | 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 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 TID (3 times per day) | Experimental | 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) |
| PRO-157 QID (4 times per day) | Experimental | 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) |
| Moxifloxacin (Vigamox®) | Active comparator | 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 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) |
| Gatifloxacin (Zymar®) | Active comparator | Drug: Zymar®, 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) |
Who may qualify
- Ages
- 1 day to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Obtained from physician office visit.
- Diagnosis of bacterial conjunctivitis (signs and / or symptoms and / or culture).
- Informed Consent signed and dated (consent of the parents for minor patients).
Key exclusion criteria (11 listed)
- absence of written informed consent.
- Women of childbearing age, without contraceptive use (oral contraceptive pill, contraceptive intrauterine device, contraceptive implant, patch or condom).
- Pregnant or breastfeeding women.
- Subjects that could not be evaluated partially or totally according to the protocol.
- Subjects with topical, systemic or intravenous medication with any type of antibiotic on the day of the baseline visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRO-157Also: Pazufloxacin 0.06%, ophthalmic solutionPRO-157 (Pazufloxacin 0.06%) Laboratories Sophia S.A. de C.V., ophthalmic solution | Drug | PRO-157 BID (2 times per day), PRO-157 QID (4 times per day), PRO-157 TID (3 times per day) |
| VigamoxAlso: MoxifloxacinVigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution | Drug | Moxifloxacin (Vigamox®) |
| Zymar®Also: GatifloxacinZymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution | Drug | Gatifloxacin (Zymar®) |
| Lagricel Ofteno®Also: Sodium hyaluronate 0.4%Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution | Drug | Gatifloxacin (Zymar®), Moxifloxacin (Vigamox®), PRO-157 BID (2 times per day), PRO-157 QID (4 times per day), PRO-157 TID (3 times per day) |
Primary outcome
Change From Baseline Bacterial Culture
Time frame: up to one week
Efficacy will be determined comparing the cultures of the lower conjunctival pouch, of the baseline (day 1) against final visit (day 8), quantifying and identifying the colony forming units (CFU) by genus and species. The evaluated variable is discrete quantitative type and the scale of measurement used will be CFU x mL considering the eradication, reduction or proliferation of the bacterial agent. It will be determined as effective if there is a reduction in number of bacterial flora in at least 95% of the evaluated subjects.
Adverse Events
Time frame: during the intervention period for 7 days, and 15 days after the final visit
Number of adverse events: dependent variable, discrete quantitative, the number of adverse events per group will be compared at the end of the study and it will be considered safe if there is not greater increase of 5% of serious adverse events.
5 secondary outcomes
Cases Frequency of Ocular Secretion
Time frame: Up to one week.
Number of Cases of Conjunctival Hyperemia
Time frame: up to one week
Chemosis Frequency
Time frame: up to one week
Eyelid Edema Frequency
Time frame: Up to one week
Frequency of Corneal Epithelial Defects
Time frame: Up to one week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leopoldo Baiza, MD study director
Laboratorios Sophia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRO-157, Vigamox and Zymar® in people with Bacterial Conjunctivitis, run by Laboratorios Sophia S.A de C.V. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Bacterial Culture (time frame: up to one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2019.