Safety and Tolerability of the PRO-174 Versus Sophixín Ofteno®, on the Ocular Surface of Healthy Subjects

NCT ID: NCT03519516

Last Updated: 2019-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-25
• Study Completion Date: 2018-06-10

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.

Conditions

Conjunctivitis; Conjunctivitis, Bacterial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

PRO-174

Active ingredient: Levofloxacin 0.5%

o Dosage: 1 drop in both eyes, 8 times a day during the waking period

Group Type: EXPERIMENTAL

PRO-174

Intervention Type: DRUG

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

Sophixín Ofteno®

o Dosage: 1 drop in both eyes, 8 times a day during the waking period

Group Type: ACTIVE_COMPARATOR

Sophixín Ofteno®

Intervention Type: DRUG

• 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

Interventions

PRO-174

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

Sophixín Ofteno®

• 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

Intervention Type: DRUG

Other Intervention Names

PRO174; Levofloxacin Ophthalmic Solution; Ciprofloxacin Ophthalmic solution

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laboratorios Sophia S.A de C.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leopoldo Baiza Durán, MD

Role: STUDY_DIRECTOR

Laboratorios Sophia S.A de C.V.

Locations

Private Medical Offices

Guadalajara, Jalisco, Mexico

Countries

Mexico

References

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.

Reference Type: DERIVED

PMID: 34707360 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SOPH174-0816/I

Identifier Type: -

Identifier Source: org_study_id