Back to resultsSafety and Tolerability of the PRO-174 Versus Sophixín Ofteno®, on the Ocular Surface of Healthy Subjects (PRO-174/I)
Primary Purpose
Conjunctivitis, Conjunctivitis, Bacterial
Status
Completed
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
PRO-174
Sophixín Ofteno®
Sponsored by
About this trial
This is an interventional treatment trial for Conjunctivitis focused on measuring ocular antibiotic, quinolone, levofloxacin, ophthalmic antibiotic, antibiotic in drops
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent.
- Systemically and ophthalmologically healthy subjects evaluated during the clinical history.
- Age between 18 to 45 years.
- Both genders.
- Blood tests (complete blood count, blood chemistry of three elements and liver function tests) within normal parameters specified by the reference laboratory with a lower and upper margin of 10%.
- Vital signs within normal parameters. (Vital signs at rest: blood pressure ≤ 139/89 mmHg, heart rate 60 -100 beats per minute and respiratory rate of 12-24 breaths per minute).
- Visual capacity 20/30 or better, in both eyes.
- Intraocular pressure ≥11 and ≤ 21 mmHg.
Exclusion Criteria:
General criteria
- Subjects with a history of hypersensitivity to any of the components of the research products.
- Subject users of topical ophthalmic medications of any pharmacological group.
- Subject users of medication by any other route of administration.
- Pregnant or lactating women.
- Women of childbearing age, who do not ensure a hormonal contraceptive method or intrauterine device during the study period or without a history of bilateral tubal obstruction, oophorectomy or hysterectomy; as fertile age we understand women who have not had their menopause, defined as 12 months since the last menstruation in women over 40 years.
- Subjects with participation in clinical research studies 90 days prior to inclusion in the present study.
- Diagnosis of liver disease or elevation to three times the normal upper value of any of the following liver enzymes: aspartate transferase (AST), alanine transferase (ALT) or bilirubin.
- Inability to attend or answer the evaluations made in each of the visits.
- Positive smoking (specified as cigarette consumption regardless of amount and frequency)
- Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period).
- Contact lens users.
- An occlusive iridocorneal angle, defined as a trabecular mesh visible at less than 90 ° from the angular circumference to gonioscopy.
Sites / Locations
- Private Medical Offices
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PRO-174
Sophixín Ofteno®
Arm Description
Active ingredient: Levofloxacin 0.5% o Dosage: 1 drop in both eyes, 8 times a day during the waking period
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03519516
First Posted
April 26, 2018
Last Updated
October 2, 2019
Sponsor
Laboratorios Sophia S.A de C.V.
1. Study Identification
Unique Protocol Identification Number
NCT03519516
Brief Title
Safety and Tolerability of the PRO-174 Versus Sophixín Ofteno®, on the Ocular Surface of Healthy Subjects
Acronym
PRO-174/I
Official Title
Phase I Clinical Trial, to Evaluate the Safety and Tolerability of the Ophthalmic Solution PRO-174 Versus Sophixín Ofteno®, Elaborated by Laboratorios Sophia on the Ocular Surface of Ophthalmological and Clinically Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 25, 2018 (Actual)
Primary Completion Date
May 25, 2018 (Actual)
Study Completion Date
June 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Sophia S.A de C.V.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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:
PRO-174. Levofloxacin 0.5% ophthalmic solution. Prepared by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
Dosage: 1 drop every 2 hours during the waking period (8 daily applications), on day 1 and 2; continuing with 1 drop every 4 hours during the waking period (4 daily applications) from day 3 to 7. Both eyes.
Route of administration: ophthalmic
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conjunctivitis, Conjunctivitis, Bacterial
Keywords
ocular antibiotic, quinolone, levofloxacin, ophthalmic antibiotic, antibiotic in drops
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The blinding will correspond to the research subject and the principal investigator. In addition, the statistical analysis will be carried out in a blinded manner for the partial and final analysis.
The masking will be done using boxes in the primary packaging identical in the two groups. Blinding for the research subject and the researcher will be done by replacing the commercial labels in the case of the comparator in the bottles and the use of identical labels that contain the allocation number.
Blinding may be opened in the following cases:
Presence of a serious adverse event.
Safety alarm due to the use of the drugs under study.
In case the sponsor determines it for any reason of security or other reason that considers pertinent.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRO-174
Arm Type
Experimental
Arm Description
Active ingredient: Levofloxacin 0.5%
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Arm Title
Sophixín Ofteno®
Arm Type
Active Comparator
Arm Description
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Intervention Type
Drug
Intervention Name(s)
PRO-174
Other Intervention Name(s)
PRO174, Levofloxacin Ophthalmic Solution
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Sophixín Ofteno®
Other Intervention Name(s)
Ciprofloxacin Ophthalmic solution
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Adverse Events (EAS)
Description
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).
Title
Ocular Burning (OB)
Description
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)
Secondary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Description
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)
Title
Breakup Time (BUT)
Description
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)
Title
Number of Eyes With Epithelial Defects (ED) by Grade
Description
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)
Title
Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade
Description
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)
Title
Number of Eyes With Foreign Body Sensation (FBS) by Grade
Description
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)
Title
Number of Eyes With Ocular Pruritus (P) by Grade
Description
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)
Title
Number of Eyes of Chemosis
Description
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)
Title
Visual Capacity
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Signed informed consent.
Systemically and ophthalmologically healthy subjects evaluated during the clinical history.
Age between 18 to 45 years.
Both genders.
Blood tests (complete blood count, blood chemistry of three elements and liver function tests) within normal parameters specified by the reference laboratory with a lower and upper margin of 10%.
Vital signs within normal parameters. (Vital signs at rest: blood pressure ≤ 139/89 mmHg, heart rate 60 -100 beats per minute and respiratory rate of 12-24 breaths per minute).
Visual capacity 20/30 or better, in both eyes.
Intraocular pressure ≥11 and ≤ 21 mmHg.
Exclusion Criteria:
General criteria
Subjects with a history of hypersensitivity to any of the components of the research products.
Subject users of topical ophthalmic medications of any pharmacological group.
Subject users of medication by any other route of administration.
Pregnant or lactating women.
Women of childbearing age, who do not ensure a hormonal contraceptive method or intrauterine device during the study period or without a history of bilateral tubal obstruction, oophorectomy or hysterectomy; as fertile age we understand women who have not had their menopause, defined as 12 months since the last menstruation in women over 40 years.
Subjects with participation in clinical research studies 90 days prior to inclusion in the present study.
Diagnosis of liver disease or elevation to three times the normal upper value of any of the following liver enzymes: aspartate transferase (AST), alanine transferase (ALT) or bilirubin.
Inability to attend or answer the evaluations made in each of the visits.
Positive smoking (specified as cigarette consumption regardless of amount and frequency)
Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period).
Contact lens users.
An occlusive iridocorneal angle, defined as a trabecular mesh visible at less than 90 ° from the angular circumference to gonioscopy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leopoldo Baiza Durán, MD
Organizational Affiliation
Laboratorios Sophia S.A de C.V.
Official's Role
Study Director
Facility Information:
Facility Name
Private Medical Offices
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34707360
Citation
Munoz-Villegas P, Navarro-Sanchez AA, Sanchez-Rios A, Olvera-Montano O, Baiza-Duran LM. Reexamining Ophthalmic Drugs, Safety and Tolerability in Phase 1 Clinical Trials. Ther Clin Risk Manag. 2021 Oct 21;17:1123-1134. doi: 10.2147/TCRM.S331294. eCollection 2021.
Results Reference
derived
Learn more about this trial
Safety and Tolerability of the PRO-174 Versus Sophixín Ofteno®, on the Ocular Surface of Healthy Subjects
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