NCT03965052

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Glaucoma

Interventions

Type	Name	Description
DRUG	PRO 179	* Generic name: Travoprost * Distinctive denomination: Bristrio® (PRO-179) * Active principles: Travoprost 0.004%. * Pharmaceutical form: Ophthalmic solution * Presentation: multi-dose dropper bottle, 2.5 milliliters. * Prepared by: Sophia Laboratories, S.A. of C.V. * Description of the solution: transparent solution, free of visible particles. * Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene.
DRUG	Travatan 0.004 % Ophthalmic Solution	* Generic name: Travoprost * Distinctive denomination: Travatan® * Active ingredients: Travoprost 0.004% * Pharmaceutical form: Ophthalmic solution. * Presentation: multi-dose dropper bottle, 2.5 milliliters. * Prepared by: Alcon Laboratories Inc. * Description of the solution: transparent solution, free of visible particles. * Consult information to prescribe.

Timeline

• Start date: 2019-04-24
• Primary completion: 2019-07-02
• Completion: 2019-08-29
• First posted: 2019-05-28
• Last updated: 2019-12-12
• Results posted: 2019-12-12

Locations

1 site across 1 country: Mexico