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Assessing the Safety and Efficacy of AVX-012 in Subjects With Mild-to-moderate Dry Eye Syndrome (AVX012CT001)

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ClinicalTrials.gov Identifier: NCT03162094
Recruitment Status : Recruiting
First Posted : May 22, 2017
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Avizorex Pharma, S.L.

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):


Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Drug: AVX012 Ophthalmic Solution Low dose Drug: AVX012 Ophthalmic Solution High dose Drug: Placebo (vehicle) Phase 1 Phase 2

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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

Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: phase I/II, double-blind
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 3, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: 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

Drug: AVX012 Ophthalmic Solution Low dose
Ocular topical administration of AVX Ophthalmic Solution Low dose

Experimental: 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

Drug: AVX012 Ophthalmic Solution High dose
Ocular topical administration of AVX Ophthalmic Solution High dose

Placebo Comparator: 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

Drug: Placebo (vehicle)
Ocular topical administration of placebo (vehicle Ophthalmic Solution)




Primary Outcome Measures :
  1. The objective of part A is to evaluate the safety of AVX-012 ophthalmic solution in subjects with dry eye syndrome. [ Time Frame: 7 days (+1 day) ]
    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).

  2. The objective of part B is to evaluate the efficacy of AVX-012 ophthalmic solution in treating symptoms of dry eye. [ Time Frame: 28 days (+7 days) ]
    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).


Secondary Outcome Measures :
  1. Confirm the safety of AVX-012 ophthalmic solution in subjects with dry eye syndrome. [ Time Frame: 28 days (+7 days) ]
    Percentage of patients with adverse events from baseline (treatment period and post-treatment safety follow-up) according to the different dosing frequencies (TID and BID).

  2. Change from baseline in corneal staining score [ Time Frame: 28 days (+7 days) ]
  3. Change from baseline in Schirmer I test score [ Time Frame: 28 days (+7 days) ]
  4. Change from baseline in tear film break up time score [ Time Frame: 28 days (+7 days) ]
  5. Change from baseline in conjunctival staining score [ Time Frame: 28 days (+7 days) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162094


Contacts
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Contact: Avziorex Pharma, S.L. +34934029026 patrick.tresserras@avxpharma.com

Locations
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Spain
Clinica Oftalvist Jerez Not yet recruiting
Jerez De La Frontera, Cadiz, Spain, 11407
Contact: Ramón Ruiz Mesa, Dr         
Clínica Universitaria de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Clínica Oftalvist Vistahermosa Not yet recruiting
Alicante, Spain, 03015
Contact: Enrique Artiaga Elordi, Dr         
Innova Ocular ICO Barcelona Recruiting
Barcelona, Spain, 08006
Centro de Oftalmologia Barraquer Not yet recruiting
Barcelona, Spain, 08021
Contact: Jose Lamarca Mateu, Dr.         
H Vall de Hebron Not yet recruiting
Barcelona, Spain, 08035
Contact: Sara Martin Naldas, Dra.         
H Clinic Recruiting
Barcelona, Spain, 08036
H General de Cataluña Recruiting
Barcelona, Spain, 08190
H Germas Trias Pujol Not yet recruiting
Barcelona, Spain, 08916
Contact: Antoni Sabala Llopart, Dr         
clínica Oftalvist Granada Not yet recruiting
Granada, Spain, 18004
Contact: Eva Delgado Alonso, Dr.         
Clínica Universitaria de Navarra_ Madrid Not yet recruiting
Madrid, Spain, 28027
Contact: Javier Moreno Montañes, Dr         
Clínica Oftalvist Moncloa Not yet recruiting
Madrid, Spain, 28028
Contact: Enrique Artega Elordi, Dr         
H Universitario Ramón y Cajal Recruiting
Madrid, Spain, 28034
H Clínico San Carlos Recruiting
Madrid, Spain, 28040
Hospital General Universitario Reina Sofía Recruiting
Murcia, Spain, 30003
Instituto Oftalmológico Fernández Vega Recruiting
Oviedo, Spain, 33012
clinica Oftalvist Valencia Not yet recruiting
Valencia, Spain, 46004
Contact: Francisco Pastor Pascual, Dr         
Hospital Universitario La Fé Not yet recruiting
Valencia, Spain, 46026
Contact: Salvador García Delpech, Dr         
Instituto Universitario de Oftalmobiología Aplicada (IOBA) Recruiting
Valladolid, Spain, 47011
H Miguel Servet Recruiting
Zaragoza, Spain, 50004
H Universitario Lozano Blesa Recruiting
Zaragoza, Spain, 50009
Sponsors and Collaborators
Avizorex Pharma, S.L.
Investigators
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Study Director: Patrick Tresserras Avizorex Pharma, S.L.

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Responsible Party: Avizorex Pharma, S.L.
ClinicalTrials.gov Identifier: NCT03162094     History of Changes
Other Study ID Numbers: AVX012 CT001
2016-001022-34 ( EudraCT Number )
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Ophthalmic Solutions
Syndrome
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions