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
Overview
- Phase
- Phase 1
- Intervention
- PRO-174
- Conditions
- Conjunctivitis
- Sponsor
- Laboratorios Sophia S.A de C.V.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Number of Adverse Events (EAS)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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)
Arms & Interventions
PRO-174
Active ingredient: Levofloxacin 0.5% o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Intervention: PRO-174
Sophixín Ofteno®
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Intervention: Sophixín Ofteno®
Outcomes
Primary Outcomes
Number of Adverse Events (EAS)
Time Frame: during the 12 days of evaluation, including the safety call (day 12).
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)
Time Frame: will be evaluated at the end of the treatment at the final visit (day 7)
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 Outcomes
- Intraocular Pressure (IOP)(will be evaluated at the end of the treatment at the final visit (day 7))
- Breakup Time (BUT)(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(will be evaluated at the end of the treatment at the final visit (day 7))
- Number of Eyes With Ocular Pruritus (P) by Grade(will be evaluated at the end of the treatment at the final visit (day 7))
- Visual Capacity(will be evaluated at the end of the treatment at the final visit (day 7))
- Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade(will be evaluated at the end of the treatment at the final visit (day 7))
- Number of Eyes of Chemosis(will be evaluated at the end of the treatment at the final visit (day 7))
- Number of Eyes With Epithelial Defects (ED) by Grade(will be evaluated at the end of the treatment at the final visit (day 7))