NCT03966365

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

• 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

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.

Detailed description

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.

Conditions

• Glaucoma

Interventions

Type	Name	Description
DRUG	PRO-122	* PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. * Route of administration: topical ophthalmic.
DRUG	Krytantek Ofteno®	* \- 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico. * \- Route of administration: topical ophthalmic.

Timeline

• Start date: 2019-05-02
• Primary completion: 2019-08-30
• Completion: 2019-08-30
• First posted: 2019-05-29
• Last updated: 2019-12-13
• Results posted: 2019-12-13

Locations

1 site across 1 country: Mexico