Clinical trial NCT03519516: Safety and Tolerability of the PRO-174 Versus Sophixín Ofteno®, on the Ocular Surface of Healthy Subjects
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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Conjunctivitis
Conjunctivitis, Bacterial
Keywords: ocular antibiotic
quinolone
levofloxacin
ophthalmic antibiotic
antibiotic in drops
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2018-05-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Adverse Events (EAS)
timeFrame: during the 12 days of evaluation, including the safety call (day 12).
measure: Ocular Burning (OB)
timeFrame: will be evaluated at the end of the treatment at the final visit (day 7)
Secondary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: will be evaluated at the end of the treatment at the final visit (day 7)
measure: Breakup Time (BUT)
timeFrame: will be evaluated at the end of the treatment at the final visit (day 7)
measure: Number of Eyes With Epithelial Defects (ED) by Grade
timeFrame: will be evaluated at the end of the treatment at the final visit (day 7)
measure: Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade
timeFrame: will be evaluated at the end of the treatment at the final visit (day 7)
measure: Number of Eyes With Foreign Body Sensation (FBS) by Grade
timeFrame: will be evaluated at the end of the treatment at the final visit (day 7)
measure: Number of Eyes With Ocular Pruritus (P) by Grade
timeFrame: will be evaluated at the end of the treatment at the final visit (day 7)
measure: Number of Eyes of Chemosis
timeFrame: will be evaluated at the end of the treatment at the final visit (day 7)
measure: Visual Capacity
timeFrame: will be evaluated at the end of the treatment at the final visit (day 7)
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Private Medical Offices
state: Jalisco
Study officials:
affiliation: Laboratorios Sophia S.A de C.V.
name: Leopoldo Baiza Durán, MD
role: STUDY_DIRECTOR
References:
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.