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

• Status: Completed
• Trial end date: 2018-06-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Laboratorios Sophia S.A de C.V.
• Treatments: Ciprofloxacin; Levofloxacin; Ofloxacin; Ophthalmic Solutions; Pharmaceutical Solutions

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.