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

Phase I Clinical Study, to Evaluate the Safety and Tolerability of the Preservative-free Ophthalmic Solution PRO-122 Compared With Krytantek Ofteno®, Elaborated by Sophia Laboratories, S.A. of C.V. on the Ocular Surface of Ophthalmologically and Clinically Healthy Subjects

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.

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

Treatment duration: 7 days. Duration of subject in the study: 15 to 22 days.

Adverse events will be reported and cataloged based on the MedDRA dictionary and will be reported to the corresponding regulatory entity.

The sponsor will carry out monitoring or quality visits to the research sites where it corroborates the information of the source documents and will contrast them with the information presented in the electronic CRF. Electronic case report forms will be evaluated by the clinical research associate and the clinical team of the sponsor (medical ophthalmologist researcher and pharmacologist of clinical safety).

Statistical methodology:

The data will be expressed with measures of central tendency: mean and standard deviation for the quantitative variables. The qualitative variables will be presented in frequencies and percentages. The statistical analysis will be carried out by means of the Mann-Whitney U test for the quantitative variables for the difference between the groups. The difference between the qualitative variables will be analyzed by means of X2 (Chi2). An alpha ≤ 0.05 will be considered significant.

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.