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

NCT03162094 | Unknown Phase 1 DMC

• 2 other identifiers: AVX012 CT0012016-001022-34
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 21

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):

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (2)

• The objective of part A is to evaluate the safety of AVX-012 ophthalmic solution in subjects with dry eye syndrome.

  Evaluation of vital signs (blood pressure and heart rate), laboratory analyses (haematology, biochemistry, and urine pregnancy test), best-corrected visual acuity (ETDRS), corneal anaesthesia (Cochet-Bonnet), intraocular pressure, biomicroscopy/staining (fluorescein), and ophthalmoscopy (dilated).

  7 days (+1 day)

• The objective of part B is to evaluate the efficacy of AVX-012 ophthalmic solution in treating symptoms of dry eye.

  Percentage of patients achieving an improvement ≥ 20 points in the Symptom Assessment in Dry Eye (SANDE) questionnaire according to the different dosing frequencies (TID and BID).

  28 days (+7 days)

Secondary Outcomes (5)

• Confirm the safety of AVX-012 ophthalmic solution in subjects with dry eye syndrome.

  28 days (+7 days)

• Change from baseline in corneal staining score

  28 days (+7 days)

• Change from baseline in Schirmer I test score

  28 days (+7 days)

• Change from baseline in tear film break up time score

  28 days (+7 days)

• Change from baseline in conjunctival staining score

  28 days (+7 days)

Study Arms (3)

AVX-012 Opthalmic Solution Low dose

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

Drug: AVX012 Ophthalmic Solution Low dose

AVX-012 Opthalmic Solution High dose

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

Drug: AVX012 Ophthalmic Solution High dose

Placebo (Vehicle) Opthalmic Solution

PLACEBO COMPARATOR

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

Drug: Placebo (vehicle)

Interventions

AVX012 Ophthalmic Solution Low dose DRUG

Ocular topical administration of AVX Ophthalmic Solution Low dose

AVX-012 Opthalmic Solution Low dose

AVX012 Ophthalmic Solution High dose DRUG

Ocular topical administration of AVX Ophthalmic Solution High dose

AVX-012 Opthalmic Solution High dose

Placebo (vehicle) DRUG

Ocular topical administration of placebo (vehicle Ophthalmic Solution)

Placebo (Vehicle) Opthalmic Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avizorex Pharma, S.L.: lead

Study Sites (21)

Clinica Oftalvist Jerez

Jerez de la Frontera, Cadiz, 11407, Spain

NOT YET RECRUITING

Clínica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Clínica Oftalvist Vistahermosa

Alicante, 03015, Spain

NOT YET RECRUITING

Innova Ocular ICO Barcelona

Barcelona, 08006, Spain

RECRUITING

Centro de Oftalmologia Barraquer

Barcelona, 08021, Spain

NOT YET RECRUITING

H Vall de Hebron

Barcelona, 08035, Spain

NOT YET RECRUITING

H Clinic

Barcelona, 08036, Spain

RECRUITING

H General de Cataluña

Barcelona, 08190, Spain

RECRUITING

H Germas Trias Pujol

Barcelona, 08916, Spain

NOT YET RECRUITING

clínica Oftalvist Granada

Granada, 18004, Spain

NOT YET RECRUITING

Clínica Universitaria de Navarra_ Madrid

Madrid, 28027, Spain

NOT YET RECRUITING

Clínica Oftalvist Moncloa

Madrid, 28028, Spain

NOT YET RECRUITING

H Universitario Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

H Clínico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital General Universitario Reina Sofía

Murcia, 30003, Spain

RECRUITING

Instituto Oftalmológico Fernández Vega

Oviedo, 33012, Spain

RECRUITING

clinica Oftalvist Valencia

Valencia, 46004, Spain

NOT YET RECRUITING

Hospital Universitario La Fé

Valencia, 46026, Spain

NOT YET RECRUITING

Instituto Universitario de Oftalmobiología Aplicada (IOBA)

Valladolid, 47011, Spain

RECRUITING

H Miguel Servet

Zaragoza, 50004, Spain

RECRUITING

H Universitario Lozano Blesa

Zaragoza, 50009, Spain

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Patrick Tresserras

  Avizorex Pharma, S.L.

  STUDY DIRECTOR

Central Study Contacts

Avziorex Pharma, S.L.

CONTACT

+34934029026; patrick.tresserras@avxpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: phase I/II, double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase I: patient will be included on 3 arms of treatment ( Placebo, Low dose or High dose AVX-012) TID Phase II: Patient will be included on 4 arms of treatment (Placebo/Dose) BID/TID

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: May 22, 2017
• Study Start: April 3, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 1, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (21)