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Assessing the Safety and Efficacy of AVX-012 in Subjects With Mild-to-moderate Dry Eye Syndrome

NCT03162094 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2018-10-01

No results posted yet for this study

Summary

This is a first-in-human phase I/II randomized, double-blind, placebo (vehicle)-controlled, multicenter study to assess the Safety and Efficacy of AVX-012 Ophthalmic Solution in subjects with Mild-to-Moderate Dry Eye Syndrome.

The study consists of two parts (part A and part B):

Conditions

  • Dry Eye Syndrome

Interventions

DRUG

AVX012 Ophthalmic Solution Low dose

Ocular topical administration of AVX Ophthalmic Solution Low dose

DRUG

AVX012 Ophthalmic Solution High dose

Ocular topical administration of AVX Ophthalmic Solution High dose

DRUG

Placebo (vehicle)

Ocular topical administration of placebo (vehicle Ophthalmic Solution)

Sponsors & Collaborators

  • Avizorex Pharma, S.L.

    lead INDUSTRY

Principal Investigators

  • Patrick Tresserras · Avizorex Pharma, S.L.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-03
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Spain

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 NCT03162094 on ClinicalTrials.gov