Safety and Tolerability of PRO-087 Versus Xyel Ofteno® and Systane Ultra®, on the Ocular Surface of Healthy Subjects

• Status: Completed
• Trial end date: 2018-03-27
• Target enrollment: 0
• Participant gender: All

Summary

Phase I clinical study, to evaluate the safety and tolerability of the preservative-free ophthalmic solution PRO-087 versus Xyel Ofteno® and Systane Ultra®, on the ocular surface of ophthalmological and clinically healthy subjects.

Objective: To evaluate the safety and tolerability of the preservative-free formulation PRO-087 manufactured by Laboratorios Sophia S.A. of C.V. on the ocular surface of clinically healthy subjects.

Hypothesis:

The ophthalmic solution PRO-087 presents a profile of safety and tolerability similar to comparators in healthy subjects

Methodology:

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

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

Details

• Lead Sponsor: Laboratorios Sophia S.A de C.V.
• Treatments: Hyaluronic Acid; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Systemically and ophthalmologically healthy subjects

• Signed informed consent.

• Age between 18 to 40 years.

• Both genders

• Blood tests [complete blood count (BHC), three element blood chemistry (QS) and liver function tests (PFH)] within normal parameters

• Visual capacity 20/30 or better

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 or hysterectomy, 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).

• Users of contact lenses.