NCT04693429

Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+

Phase I Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution, Manufactured by Laboratorios Sophia, S.A. de C.V., When Applied on the Ocular Surface of Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Clinical phase I, controlled, non comparative, open, single center study evaluating the safety and tolerability of ophthalmic solution PRO-172 when applied on the ocular surface of healthy volunteers.

Conditions

• Safety
• Tolerability
• Ocular Surface
• Ocular Comfort

Interventions

Type	Name	Description
DRUG	Bepotastine Besilate	Bepotastine Besilate 1.5% QID (quater in die) for 7 days

Timeline

• Start date: 2020-09-24
• Primary completion: 2020-11-27
• Completion: 2020-12-08
• First posted: 2021-01-05
• Last updated: 2025-07-16
• Results posted: 2025-07-16

Locations

1 site across 1 country: Mexico