Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®

• Status: Completed
• Trial end date: 2019-08-30
• Target enrollment: 0
• Participant gender: All

Summary

Therapeutic indication: Ocular hypotensive Use: Primary open-angle glaucoma and ocular hypertension.

Objectives: To evaluate the safety and tolerability of the preservative-free formulation PRO-122 manufactured by Sophia Laboratories, S.A. of C.V. on the ocular surface of clinically healthy subjects.

Hypothesis: The ophthalmic solution PRO-122 presents a profile of safety and tolerability similar to Krytantek Ofteno®, in healthy subjects.

Methodology: Phase I clinical trial, controlled, parallel group, double blind, randomized.

Number of patients: n=24 12 subjects per group (both eyes). Main inclusion criteria:Clinically healthy subjects.

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

Details

• Lead Sponsor: Laboratorios Sophia S.A de C.V.
• Treatments: Brimonidine Tartrate; Dorzolamide; Ophthalmic Solutions; Pharmaceutical Solutions; Timolol

Criteria

Inclusion Criteria:

• - Clinically healthy

• Ability to give your signed informed consent, and show willingness to comply with study procedures and to modify your lifestyle activities (Section 6.2.2)

• Age between 18 to 45 years.

• Indistinct sex.

• Women must ensure a hormonal contraceptive method or intrauterine device during the study period.

• 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.

• Visual ability 20/30 or better in both eyes.

• Vital signs within normal parameters.

• Intraocular pressure ≥10 and ≤ 21 mmHg.

Exclusion Criteria:

• Users of topical ophthalmic products of any kind.

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

• Women who are pregnant or breastfeeding.

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

• Previous participation in this same study.

• Users of contact lenses.

• History of any chronic-degenerative disease.

• Inflammatory or infectious disease, active at the time of study entry.

• Injuries or traumatisms not resolved at the time of admission to the study.