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

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.

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.

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

duration: 10 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) or Fisher's exact. An alpha ≤ 0.05 will be considered significant.

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.