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

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Laboratorios Sophia

Status and phase

Completed
Phase 1

Conditions

Conjunctivitis
Conjunctivitis, Bacterial

Treatments

Drug: Sophixín Ofteno®
Drug: PRO-174

Study type

Interventional

Funder types

Industry

Identifiers

NCT03519516
SOPH174-0816/I

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

30 participants in 2 patient groups

PRO-174
Experimental group
Description:
Active ingredient: Levofloxacin 0.5% o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Treatment:
Drug: PRO-174
Sophixín Ofteno®
Active Comparator group
Description:
o Dosage: 1 drop in both eyes, 8 times a day during the waking period
Treatment:
Drug: Sophixín Ofteno®

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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