Suspended

AVX012CT001A 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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

AVX012 Ophthalmic Solution Low dose

+ AVX012 Ophthalmic Solution High dose

+ Placebo (vehicle)

Drug
Who is being recruted

Eye Diseases

+ Lacrimal Apparatus Diseases

+ Dry Eye Syndromes

Over 18 Years
+33 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1 & 2
Interventional
Study Start: April 2017
See protocol details

Summary

Principal SponsorAvizorex Pharma, S.L.
Study ContactAvziorex Pharma, S.L.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 3, 2017

Actual date on which the first participant was enrolled.

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).

Official TitleA 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
NCT03162094
Principal SponsorAvizorex Pharma, S.L.
Study ContactAvziorex Pharma, S.L.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

172 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesLacrimal Apparatus DiseasesDry Eye Syndromes

Criteria

9 inclusion criteria required to participate
Male or female subjects of at least 18 years of age.
Diagnosis of dry eye (by a health care professional) for at least 3 months prior to screening visit.
Normal lid anatomy.
Intraocular pressure less than 22 mmHg (inclusive) in each eye.
Show More Criteria
24 exclusion criteria prevent from participating
History of other than dry eye, ocular surface of moderate to severe Meibomian gland disease (grades +++ to ++++ [moderately to severely altered expressibility and secretion quality]: moderate symptoms with mild to moderate corneal staining, mainly peripheral; or marked symptoms with marked corneal staining, central in addition), chronic, or acute ophthalmic disease in either eye, including glaucoma, macular degeneration, clinically significant cataract (primary or secondary).
Best-corrected visual acuity score of 55 letters read or lower in each eye as measured by ETDRS (letters read method).
Previous history of drug or any ingredient hypersensitivity.
Intraocular or strabismus surgery or glaucoma laser surgery within the previous 6 months.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Phase I: AVX-012 ophthalmic solution Low dose administration three times per day (TID) for 7 days Phase II: If the low dose of AVX012 is selected on phase I, AVX-012 ophthalmic solution Low dose administration three times per day (TID) and two times per day (BID) for 28 days

Group II

Experimental
Phase I: AVX-012 ophthalmic solution High dose administration three times per day (TID) for 7 days Phase II: If the high dose of AVX012 is selected on phase I, AVX-012 ophthalmic solution High dose administration three times per day (TID) and two times per day (BID) for 28 days

Group III

Placebo
Phase I: Placebo ophthalmic solution administration three times per day (TID) for 7 days Phase II: Placebo ophthalmic solution administration three times per day (TID) and two times per day (BID) for 28 days

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 21 locations

Recruiting

Clínica Universitaria de Navarra

Pamplona, SpainOpen Clínica Universitaria de Navarra in Google Maps
Recruiting

Innova Ocular ICO Barcelona

Barcelona, Spain
Recruiting

H Clinic

Barcelona, Spain
Recruiting

H General de Cataluña

Barcelona, Spain
Suspended21 Study Centers