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

NCT ID: NCT03162094

Last Updated: 2018-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-03
• Study Completion Date: 2018-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

AVX-012 Opthalmic Solution Low dose

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 Type: EXPERIMENTAL

AVX012 Ophthalmic Solution Low dose

Intervention Type: DRUG

Ocular topical administration of AVX Ophthalmic Solution Low dose

AVX-012 Opthalmic Solution High dose

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 Type: EXPERIMENTAL

AVX012 Ophthalmic Solution High dose

Intervention Type: DRUG

Ocular topical administration of AVX Ophthalmic Solution High dose

Placebo (Vehicle) Opthalmic Solution

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

Group Type: PLACEBO_COMPARATOR

Placebo (vehicle)

Intervention Type: DRUG

Ocular topical administration of placebo (vehicle Ophthalmic Solution)

Interventions

AVX012 Ophthalmic Solution Low dose

Ocular topical administration of AVX Ophthalmic Solution Low dose

Intervention Type: DRUG

AVX012 Ophthalmic Solution High dose

Ocular topical administration of AVX Ophthalmic Solution High dose

Intervention Type: DRUG

Placebo (vehicle)

Ocular topical administration of placebo (vehicle Ophthalmic Solution)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.
• Best-corrected visual acuity measured by ETDRS in each eye of 20/200 (logMAR 1.0) or better.
• Schirmer I test score of ≥ 3 mm to ≤ 9 mm/ 5 min (with anesthesia).
• SANDE symptom score of 50 or more.
• Total ocular staining of minimum 1 in Oxford scale with fluorescein and/or green lissamine.
• Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements.

Exclusion Criteria

• 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.
• History of refractive surgery in either eye (e.g., radial keratotomy, PRK, LASIK, etc.).
• Ocular trauma within the past 6 months.
• Relevant ocular pathology judged by the investigator such as; eyelid anomalies, corneal disorders, metaplasia of the ocular surface, current filamentous keratitis, or corneal neovascularization.
• Any history of herpes simplex or herpes zoster keratitis.
• Ocular infection (bacterial, viral, or fungal)
• Ocular medication of any kind, with the exception of artificial tears/gels/lubricants within the past 2 weeks of screening.
• Cyclosporine treatment during the 6 months prior to enrolment.
• Use of systemic medication that might cause dryness in the eye as a secondary effect (such as antihistaminics, hormone replacing therapies, etc.).
• Use of contact lens
• Use of additional artificial tears (other than study treatments) throughout the study, starting at screening visit.
• Participation in an investigational drug or device trial within the 30 days previous to screening visit.
• Any abnormality preventing reliable applanation tonometry of either eye.
• Central corneal thickness greater than 600 μm by conventional pachymetry.
• Signs of severe ocular surface diseases including corneal or conjunctival staining judged as severe by the investigator.
• Clinically significant systemic disease including uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular, endocrine disorders, previous cerebrovascular accident with a significant residual motor or sensory defect, progressive neurologic disorders (Parkinsonism, dementias, multiple sclerosis, unstable acquired seizure disorders) which might interfere with the study as judged by the investigator.
• Any systemic disease or medication that might course with known dryness in the eye.
• Changes of systemic medication that could have a substantial effect on intraocular pressure within 30 days prior to screening or anticipated during the study.
• Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude the safe administration of the investigational product or safe participation in this study.
• Pregnant or breastfeeding females or those with a positive pregnancy test.
• All females of childbearing potential must have a negative urine pregnancy test result at screening, and also agree to abstain from sexual intercourse with a male partner or agree to use a medically acceptable method of birth control (such as condom, diaphragm or cervical/vault cap with spermicide) until 28 days post-treatment. Males should also agree to abstain from sexual intercourse with a female partner or agree to use a condom with spermicide until 28 days post-treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avizorex Pharma, S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Tresserras

Role: STUDY_DIRECTOR

Avizorex Pharma, S.L.

Locations

Clinica Oftalvist Jerez

Jerez de la Frontera, Cadiz, Spain

Site Status: NOT_YET_RECRUITING

Clínica Universitaria de Navarra

Pamplona, Navarre, Spain

Site Status: RECRUITING

Clínica Oftalvist Vistahermosa

Alicante, , Spain

Site Status: NOT_YET_RECRUITING

Innova Ocular ICO Barcelona

Barcelona, , Spain

Site Status: RECRUITING

Centro de Oftalmologia Barraquer

Barcelona, , Spain

Site Status: NOT_YET_RECRUITING

H Vall de Hebron

Barcelona, , Spain

Site Status: NOT_YET_RECRUITING

H Clinic

Barcelona, , Spain

Site Status: RECRUITING

H General de Cataluña

Barcelona, , Spain

Site Status: RECRUITING

H Germas Trias Pujol

Barcelona, , Spain

Site Status: NOT_YET_RECRUITING

clínica Oftalvist Granada

Granada, , Spain

Site Status: NOT_YET_RECRUITING

Clínica Universitaria de Navarra_ Madrid

Madrid, , Spain

Site Status: NOT_YET_RECRUITING

Clínica Oftalvist Moncloa

Madrid, , Spain

Site Status: NOT_YET_RECRUITING

H Universitario Ramón y Cajal

Madrid, , Spain

Site Status: RECRUITING

H Clínico San Carlos

Madrid, , Spain

Site Status: RECRUITING

Hospital General Universitario Reina Sofía

Murcia, , Spain

Site Status: RECRUITING

Instituto Oftalmológico Fernández Vega

Oviedo, , Spain

Site Status: RECRUITING

clinica Oftalvist Valencia

Valencia, , Spain

Site Status: NOT_YET_RECRUITING

Hospital Universitario La Fé

Valencia, , Spain

Site Status: NOT_YET_RECRUITING

Instituto Universitario de Oftalmobiología Aplicada (IOBA)

Valladolid, , Spain

Site Status: RECRUITING

H Miguel Servet

Zaragoza, , Spain

Site Status: RECRUITING

H Universitario Lozano Blesa

Zaragoza, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Avziorex Pharma, S.L.

Role: CONTACT

patrick.tresserras@avxpharma.com

+34934029026

Facility Contacts

Ramón Ruiz Mesa, Dr

Role: primary

Enrique Artiaga Elordi, Dr

Role: primary

Jose Lamarca Mateu, Dr.

Role: primary

Sara Martin Naldas, Dra.

Role: primary

Antoni Sabala Llopart, Dr

Role: primary

Eva Delgado Alonso, Dr.

Role: primary

Javier Moreno Montañes, Dr

Role: primary

Enrique Artega Elordi, Dr

Role: primary

Francisco Pastor Pascual, Dr

Role: primary

Salvador García Delpech, Dr

Role: primary

Other Identifiers

2016-001022-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AVX012 CT001

Identifier Type: -

Identifier Source: org_study_id