A Phase 1 interventional study of PRO-174 and Sophixín Ofteno® in Conjunctivitis and Conjunctivitis, Bacterial, sponsored by Laboratorios Sophia S.A de C.V.. Completed at 1 site in Mexico. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-25.
Sponsored by Laboratorios Sophia S.A de C.V. · Phase 1, Interventional, and Treatment
Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic solution PRO-174 versus Sophixín Ofteno®, elaborated by Laboratorios Sophia, S.A. of C.V. on the ocular surface of ophthalmologically and clinically healthy subjects.
Goals:
To evaluate the safety and tolerability of the formulation PRO-174 manufactured by Laboratorios Sophia, S.A. of C.V. on the ocular surface of clinically healthy subjects.
Hypothesis:
The ophthalmic solution PRO-174 presents a safety and tolerability profile similar to the comparator in healthy subjects.
Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic solution PRO-174 versus Sophixín Ofteno®, elaborated by Laboratorios Sophia, S.A. of C.V. on the ocular surface of ophthalmologically and clinically healthy subjects.
Goals:
Methodology:
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Number of patients:
30 subjects, divided into 2 groups [15 subjects (30 eyes) exposed per group]
Test product, dose and route of administration, lot number:
Duration of treatment: 7 days
Statistical methodology:
The data will be expressed with measures of central tendency: mean and standard deviation for the quantitative variables. The qualitative variables will be presented in frequencies and percentages. The statistical analysis will be carried out through the Mann-Whitney U test for the quantitative variables for the difference between the groups. The intra-group difference will be made with the Wilcoxon rank test. The difference between the qualitative variables will be analyzed by means of X2 (Chi2). An alpha ≤ 0.05 will be considered significant.
40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.
This study's enrollment of 30 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.
Compared within Conjunctivitis, Bacterial, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Conjunctivitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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:
General 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.
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.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
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.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active ingredient: Levofloxacin 0.5% o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Drug: PRO-174
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Drug: Sophixín Ofteno®
Pharmaceutical form: ophthalmic solution * Prepared by: Laboratorios Sophia, S.A. of C.V. * Description of the solution: transparent solution, free of visible particles. * Description of container: sterile multi-dose bottle
Also known as: PRO174, Levofloxacin Ophthalmic Solution
* Active substance: Ciprofloxacin 0.3% * Pharmaceutical form: Ophthalmic solution * Prepared by: Laboratorios Sophia, S.A. of C.V. * Description of the solution: transparent solution, free of visible particles. * Description of container: sterile multi-dose bottle
Also known as: Ciprofloxacin Ophthalmic solution
Number of Adverse Events (EAS)
primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent.
Time frame: during the 12 days of evaluation, including the safety call (day 12).
Ocular Burning (OB)
primary tolerability variable Ocular burning is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.
Time frame: will be evaluated at the end of the treatment at the final visit (day 7)
Intraocular Pressure (IOP)
the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg
Time frame: will be evaluated at the end of the treatment at the final visit (day 7)
Breakup Time (BUT)
breakup time lacrimal film is a continuous variable that will be measured in seconds, evaluating the time it takes to break it, is done by direct counting and the normality range and mayor to 10 seconds.
Time frame: will be evaluated at the end of the treatment at the final visit (day 7)
Number of Eyes With Epithelial Defects (ED) by Grade
The epithelial defects will be evaluated by means of two stains, green lysine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.
Time frame: will be evaluated at the end of the treatment at the final visit (day 7)
Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade
Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very Light / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological.
Time frame: will be evaluated at the end of the treatment at the final visit (day 7)
Number of Eyes With Foreign Body Sensation (FBS) by Grade
Foreign body sensation is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.
Time frame: will be evaluated at the end of the treatment at the final visit (day 7)
Number of Eyes With Ocular Pruritus (P) by Grade
Ocular pruritus is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.
Time frame: will be evaluated at the end of the treatment at the final visit (day 7)
Number of Eyes of Chemosis
The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent.
Time frame: will be evaluated at the end of the treatment at the final visit (day 7)
Visual Capacity
The visual capacity variable will be reported using as a unit of measure a fraction, this is taken from a visual test with the Snellen primer, it is a Nominal type variable. where the optimal vision is 20/20 and higher scores indicate worse visual acuity. Snellen Scale: 20/200, 20/100, 20/70, 20/50, 20/40, 20/30, 20/25, 20/20, 20/15, 20/12, 20/10 only the denominator of the fraction of each case is reported and averaged per group.
Time frame: will be evaluated at the end of the treatment at the final visit (day 7)
| Milestone | PRO-174 | Sophixín Ofteno® |
|---|---|---|
| Started | 15 | 15 |
| Completed | 15 | 14 |
| Not completed | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 |
primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent.
| adverse events | PRO-174 | Sophixín Ofteno® |
|---|---|---|
| Number of Adverse Events (EAS) | 11 | 10 |
primary tolerability variable Ocular burning is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.
| percentage of participants | PRO-174 | Sophixín Ofteno® |
|---|---|---|
| Normal | 86.7 | 57.1 |
| Very mild | 6.7 | 14.3 |
| mild | 6.7 | 28.6 |
the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg
| mmHg | PRO-174 | Sophixín Ofteno® |
|---|---|---|
| Intraocular Pressure (IOP) | 12.53 ± 1.0 | 12.68 ± 1.7 |
breakup time lacrimal film is a continuous variable that will be measured in seconds, evaluating the time it takes to break it, is done by direct counting and the normality range and mayor to 10 seconds.
| seconds | PRO-174 | Sophixín Ofteno® |
|---|---|---|
| Breakup Time (BUT) | 15.27 ± 2.7 | 15.79 ± 2.9 |
The epithelial defects will be evaluated by means of two stains, green lysine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.
| eyes | PRO-174 | Sophixín Ofteno® |
|---|---|---|
| Green lissamine grade 1 | 2 | 0 |
| Green lissamine grade 0 | 28 | 28 |
| luorescein grade 1 | 3 | 0 |
| fluorescein grade 0 | 27 | 28 |
Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very Light / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological.
| percentage of eyes | PRO-174 | Sophixín Ofteno® |
|---|---|---|
| normal | 96.7 | 92.9 |
| very mild | 3.3 | 0 |
| Mild | 0 | 0 |
| moderate | 0 | 7.1 |
| severo | 0 | 0 |
Foreign body sensation is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.
| eyes | PRO-174 | Sophixín Ofteno® |
|---|---|---|
| Absent | 30 | 28 |
| Very mild | 0 | 0 |
| Mild | 0 | 0 |
| Moderate | 0 | 0 |
| Severe | 0 | 0 |
Ocular pruritus is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.
| number of eyes with Ocular pruritus | PRO-174 | Sophixín Ofteno® |
|---|---|---|
| Absent | 24 | 24 |
| Very mild | 4 | 2 |
| Mild | 2 | 2 |
| Moderate | 0 | 0 |
| Severe | 0 | 0 |
The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent.
| eyes | PRO-174 | Sophixín Ofteno® |
|---|---|---|
| Number of Eyes of Chemosis | 0 | 0 |
The visual capacity variable will be reported using as a unit of measure a fraction, this is taken from a visual test with the Snellen primer, it is a Nominal type variable. where the optimal vision is 20/20 and higher scores indicate worse visual acuity. Snellen Scale: 20/200, 20/100, 20/70, 20/50, 20/40, 20/30, 20/25, 20/20, 20/15, 20/12, 20/10 only the denominator of the fraction of each case is reported and averaged per group.
| units on a scale (snellen) | PRO-174 | Sophixín Ofteno® |
|---|---|---|
| Visual Capacity | 20.6 ± 2.17 | 20 ± 0 |
Collected over the adverse events were evaluated for a period of 13 days, from the baseline visit (day one) until the safety call three days after the last application of the study medication (day 13). MedDRA (V. 20.1). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PRO-174 | 0/15 (0%) | 0/15 (0%) | 9/15 (60%) |
| Sophixín Ofteno® | 0/15 (0%) | 0/15 (0%) | 8/15 (53.3%) |
| Event | PRO-174 | Sophixín Ofteno® |
|---|---|---|
| ocular burningEye disorders | 5/15 | 7/15 |
| itching in the eyeEye disorders | 3/15 | 1/15 |
| skin rashMusculoskeletal and connective tissue disorders | 2/15 | 0/15 |
| allergic rhinitisRespiratory, thoracic and mediastinal disorders | 0/15 | 1/15 |
| conjunctival hyperemiaEye disorders | 1/15 | 0/15 |
| tearingEye disorders | 0/15 | 1/15 |
ophthalmologically and clinically healthy
| Age, Continuous(years) | PRO-174 | Sophixín Ofteno® | Total |
|---|---|---|---|
| Mean | 23.67 ± 4.15 | 28.93 ± 9.38 | 26.3 ± 6.77 |
| Sex: Female, Male(Participants) | PRO-174 | Sophixín Ofteno® | Total |
|---|---|---|---|
| Female | 9 | 10 | 19 |
| Male | 6 | 5 | 11 |
| Race (NIH/OMB)(Participants) | PRO-174 | Sophixín Ofteno® | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 15 | 15 | 30 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | PRO-174 | Sophixín Ofteno® | Total |
|---|---|---|---|
| Mexico | 15 | 15 | 30 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in May 2018, 4 months.
Results were first posted in Oct 2019, 1 year 5 months after primary completion.
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Studies of the drug tested here: Levofloxacin
Laboratorios Sophia S.A de C.V. →