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

NCT03965052 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-12-12

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Laboratorios Sophia S.A de C.V.

    lead INDUSTRY

Principal Investigators

  • Leopoldo Baiza Durán, MD · Laboratorios Sophia S.A de C.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-04-24
Primary Completion
2019-07-02
Completion
2019-08-29

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

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 NCT03965052 on ClinicalTrials.gov