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

NCT04693429 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-07-16

Study results available
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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

DRUG

Bepotastine Besilate

Bepotastine Besilate 1.5% QID (quater in die) for 7 days

Sponsors & Collaborators

  • Laboratorios Sophia S.A de C.V.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-24
Primary Completion
2020-11-27
Completion
2020-12-08

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04693429 on ClinicalTrials.gov