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

NCT03519516 | Completed Phase 1 Results DMC

• 1 other identifier: SOPH174-0816/I
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Conjunctivitis; Conjunctivitis, Bacterial

Keywords

ocular antibiotic; quinolone; levofloxacin; ophthalmic antibiotic; antibiotic in drops

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  will be evaluated at the end of the treatment at the final visit (day 7)

Secondary Outcomes (8)

• 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 Epithelial Defects (ED) by Grade

  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 With Foreign Body Sensation (FBS) by Grade

  will be evaluated at the end of the treatment at the final visit (day 7)

Study Arms (2)

PRO-174

EXPERIMENTAL

Active ingredient: Levofloxacin 0.5% o Dosage: 1 drop in both eyes, 8 times a day during the waking period

Drug: PRO-174

Sophixín Ofteno®

ACTIVE COMPARATOR

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

Drug: Sophixín Ofteno®

Interventions

PRO-174 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

Also known as: PRO174, Levofloxacin Ophthalmic Solution

PRO-174

Sophixín Ofteno® 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

Also known as: Ciprofloxacin Ophthalmic solution

Sophixín Ofteno®

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Laboratorios Sophia S.A de C.V.: lead

Study Sites (1)

Private Medical Offices

Guadalajara, Jalisco, 44650, Mexico

Location

Related Publications (1)

• 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.

  PMID: 34707360 DERIVED

MeSH Terms

Conditions

Conjunctivitis; Conjunctivitis, Bacterial

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections

Results Point of Contact

• Title: Ricardo Alonso Llamas Velázquez (clinical safety pharmacologist)
• Organization: Laboratorios Sophia

ricardo.llamas@sophia.com.mx

+52 (33) 3001 4200

Study Officials

• Leopoldo Baiza Durán, MD

  Laboratorios Sophia S.A de C.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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: 1. Presence of a serious adverse event. 2. Safety alarm due to the use of the drugs under study. 3. In case the sponsor determines it for any reason of security or other reason that considers pertinent.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase I clinical trial, controlled, of parallel groups, double blind, randomized, exploratory.

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 9, 2018
• Study Start: January 25, 2018
• Primary Completion: May 25, 2018
• Study Completion: June 10, 2018
• Last Updated: October 25, 2019
• Results First Posted: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)