NCT03162094

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

A Phase I/II, Double-blind, Placebo-controlled Study Assessing the Safety and Efficacy of AVX-012 Ophthalmic Solution in Subjects With Mild-to-moderate Dry Eye Syndrome

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: Avizorex Pharma, S.L. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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):

Detailed description

The study part A will be an early safety assessment of AVX-012 ophthalmic solution (Low dose and High dose AVX-012) administered three times per day (TID) when compared with the vehicle (placebo). Approximately 24 patients will be randomized 1:1:1 to study groups (Low dose AVX-012, High dose AVX-012, or placebo \[vehicle\]). An independent safety committee will be in charge of assessing the safety of study treatments to proceed to part B. The study part B will be an efficacy and safety assessment of the dose of AVX-012 ophthalmic solution selected in the study part A (Low dose or High dose AVX-012) administered three times a day (TID) and twice a day (BID) when compared with the vehicle (placebo). Approximately 148 patients will be randomized 1:1:1:1 to study groups (Low dose or High dose AVX-012 and placebo \[vehicle\], TID and BID).

Conditions

• Dry Eye Syndrome

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2017-04-03
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2017-05-22
• Last updated: 2018-10-01

Locations

21 sites across 1 country: Spain