Safety and Tolerability of the Ophthalmic Solution PRO-179 Compared With Travatan®

• Status: Completed
• Trial end date: 2019-08-29
• Target enrollment: 0
• Participant gender: All

Summary

Phase I clinical study, to evaluate the safety and tolerability of the ophthalmic solution PRO-179 compared with Travatan®, on the ocular surface of clinically healthy subjects.

Goals: To evaluate the safety and tolerability of the formulation PRO-179 manufactured by Sophia Laboratories S.A. of C.V. on the ocular surface of clinically healthy subjects.

Hypothesis:The ophthalmic solution PRO-179 presents a profile of safety and tolerability similar to Travatan® in healthy subjects.

Methodology: Clinical trial Phase I, controlled, of parallel groups, double blind, with randomization.

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

Details

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

Criteria

Inclusion Criteria:

• Be clinically healthy.

• Have the ability to give their signed informed consent and show willingness to comply with the study procedures

• Have an age between 18 to 45 years.

• Indistinct sex.

• Women should ensure the continued use of a hormonal contraceptive method or intrauterine device (IUD) during the study period.

• Present blood tests: within normal parameters or with a range of ± 20% as long as the subject is clinically healthy.

Blood count (BH): Hemoglobin, erythrocytes, hematocrit, total leukocytes, platelets, mean corpuscular volume and mean corpuscular hemoglobin.

• Blood chemistry of three elements (QS): Glucose, urea and creatinine.

• Liver function tests (PFH): Aspartate Aminotransferase and Alanine Aminotransferase, total bilirubin, direct and indirect.

• Present visual ability 20/30 or better in both eyes.

• Present vital signs within normal parameters.

• Present intraocular pressure ≥10 and ≤ 21 mmHg.

Exclusion Criteria:

• Be a user of topical ophthalmic products of any kind.

• Be a user of medicines, or herbal products, by any other route of administration, with the exception of hormonal contraceptives in the case of women.

• In case of being a woman, being pregnant or breastfeeding.

• Have participated in clinical research studies 90 days prior to inclusion in the present study.

• Have previously participated in this same study.

• Be a user of contact lenses and can not suspend their use during the study.

• That they can not follow the lifestyle considerations described in section 6.2.2

• Having started the use of hormonal contraceptives or IUD, 30 days prior to inclusion in the present study.

• Having a history of any chronic-degenerative disease.

• Present inflammatory or infectious disease, active at the time of admission to the study.

• Present injuries or unresolved traumas at the time of entering the study.

• Having the antecedent of any type of eye surgery.

• Having undergone surgical procedures, not ophthalmological, in the last 3 months.