Safety and Tolerability of the Ophthalmic Gel PRO-167 Versus Corneregel® on Healthy Subjects.

• Status: Completed
• Trial end date: 2018-07-16
• Target enrollment: 0
• Participant gender: All

Summary

Title of the study:

Phase I clinical trial, to evaluate the safety and tolerability of the ophthalmic gel PRO-167 versus Corneregel®, on the ocular surface of ophthalmological and clinically healthy subjects.

Methodology:

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

Goals:

To evaluate the safety and tolerability of the ophthalmic gel PRO-167 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.

Hypothesis:

Ophthalmic gel PRO-167 has a safety and tolerability profile similar to that of its comparator in healthy subjects.

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

Details

• Lead Sponsor: Laboratorios Sophia S.A de C.V.
• Treatments: Pantothenic Acid

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.

• Visual capacity 20/30 or better, in both eyes.

• Intraocular pressure ≥11 and ≤ 21 mmHg.

Exclusion 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.

• Women who are pregnant or breastfeeding.

• Women without a history of hysterectomy, oophorectomy, who do not ensure a hormonal contraceptive method or intrauterine device during the study period.

• Subjects with participation in clinical research studies 90 days prior to inclusion in the present study.

• Diagnosis of liver disease or triple 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 quantity and frequency)

• Positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period)

• Contact lens users