Dry Eye SyndromePhase 1/2AVX012CT001NCT03162094
Assessing the Safety and Efficacy of AVX-012 in Subjects With Mild-to-moderate Dry Eye Syndrome
A Phase 1/2 study testing AVX012 Ophthalmic Solution Low dose and AVX012 Ophthalmic Solution High dose in people with Dry Eye Syndrome, run by Avizorex Pharma, S.L. at 21 sites in Spain.
Trial 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): Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- AVX012 Ophthalmic Solution Low dose and AVX012 Ophthalmic Solution High dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 21 sitesSpain
- Study dates
- 3 Apr 2017to Dec 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Spain21 sites, 21 recruiting
- Not yet recruiting
Clínica Oftalvist Vistahermosa
Alicante, 03015
Enrique Artiaga Elordi, Dr
- Recruiting
Innova Ocular ICO Barcelona
Barcelona, 08006
- Not yet recruiting
Centro de Oftalmologia Barraquer
Barcelona, 08021
Jose Lamarca Mateu, Dr.
- Not yet recruiting
H Vall de Hebron
Barcelona, 08035
Sara Martin Naldas, Dra.
- Recruiting
H Clinic
Barcelona, 08036
- Recruiting
H General de Cataluña
Barcelona, 08190
- Not yet recruiting
H Germas Trias Pujol
Barcelona, 08916
Antoni Sabala Llopart, Dr
- Not yet recruiting
clínica Oftalvist Granada
Granada, 18004
Eva Delgado Alonso, Dr.
- Not yet recruiting
Clinica Oftalvist Jerez
Jerez de la Frontera, Cadiz, 11407
Ramón Ruiz Mesa, Dr
- Not yet recruiting
Clínica Universitaria de Navarra_ Madrid
Madrid, 28027
Javier Moreno Montañes, Dr
- Not yet recruiting
Clínica Oftalvist Moncloa
Madrid, 28028
Enrique Artega Elordi, Dr
- Recruiting
H Universitario Ramón y Cajal
Madrid, 28034
- Recruiting
H Clínico San Carlos
Madrid, 28040
- Recruiting
Hospital General Universitario Reina Sofía
Murcia, 30003
- Recruiting
Instituto Oftalmológico Fernández Vega
Oviedo, 33012
- Recruiting
Clínica Universitaria de Navarra
Pamplona, Navarre, 31008
- Not yet recruiting
clinica Oftalvist Valencia
Valencia, 46004
Francisco Pastor Pascual, Dr
- Not yet recruiting
Hospital Universitario La Fé
Valencia, 46026
Salvador García Delpech, Dr
- Recruiting
Instituto Universitario de Oftalmobiología Aplicada (IOBA)
Valladolid, 47011
- Recruiting
H Miguel Servet
Zaragoza, 50004
- Recruiting
H Universitario Lozano Blesa
Zaragoza, 50009
About this study
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
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):
Read the 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
- Being tested
- AVX012 Ophthalmic Solution Low dose, AVX012 Ophthalmic Solution High dose, Placebo (vehicle)
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVX012 Ophthalmic Solution Low doseDrug
Ocular topical administration of AVX Ophthalmic Solution Low dose
AVX012 Ophthalmic Solution High doseDrug
Ocular topical administration of AVX Ophthalmic Solution High dose
Placebo (vehicle)Drug
Ocular topical administration of placebo (vehicle Ophthalmic Solution)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: Placebo (vehicle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 28 days (+7 days)
Secondary outcomes (5)
Confirm the safety of AVX-012 ophthalmic solution in subjects with dry eye syndrome.
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).
Measured: 28 days (+7 days)
Change from baseline in corneal staining score
Measured: 28 days (+7 days)
Change from baseline in Schirmer I test score
Measured: 28 days (+7 days)
Change from baseline in tear film break up time score
Measured: 28 days (+7 days)
Change from baseline in conjunctival staining score
Measured: 28 days (+7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start3 Apr 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avizorex Pharma, S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Tresserras, Study director, Avizorex Pharma, S.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162094
- Sponsor's protocol ID
- AVX012 CT001
- Other IDs
- 2016-001022-34, 2016
- Acronym
- AVX012CT001
- Status last verified
- Apr 2018
- First submitted
- 5 Apr 2017
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03162094
- Acronym / sponsor ID
- AVX012CT001 / AVX012 CT001
- Conditions
- Dry Eye Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Avizorex Pharma, S.L.Industry (pharma, biotech, devices)
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| AVX-012 Opthalmic Solution Low dose | Experimental | Drug: AVX012 Ophthalmic Solution Low dosePhase 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 |
| AVX-012 Opthalmic Solution High dose | Experimental | Drug: AVX012 Ophthalmic Solution High dosePhase 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 |
| Placebo (Vehicle) Opthalmic Solution | Placebo comparator | Drug: Placebo (vehicle)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVX012 Ophthalmic Solution Low doseOcular topical administration of AVX Ophthalmic Solution Low dose | Drug | AVX-012 Opthalmic Solution Low dose |
| AVX012 Ophthalmic Solution High doseOcular topical administration of AVX Ophthalmic Solution High dose | Drug | AVX-012 Opthalmic Solution High dose |
| Placebo (vehicle)Ocular topical administration of placebo (vehicle Ophthalmic Solution) | Drug | Placebo (Vehicle) Opthalmic Solution |
Primary outcome
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).
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).
5 secondary outcomes
Confirm the safety of AVX-012 ophthalmic solution in subjects with dry eye syndrome.
Time frame: 28 days (+7 days)
Change from baseline in corneal staining score
Time frame: 28 days (+7 days)
Change from baseline in Schirmer I test score
Time frame: 28 days (+7 days)
Change from baseline in tear film break up time score
Time frame: 28 days (+7 days)
Change from baseline in conjunctival staining score
Time frame: 28 days (+7 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Tresserras study director
Avizorex Pharma, S.L.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AVX012 Ophthalmic Solution Low dose and AVX012 Ophthalmic Solution High dose in people with Dry Eye Syndrome, run by Avizorex Pharma, S.L. at 21 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Avziorex Pharma, S.L. (+34934029026, patrick.tresserras@avxpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2018.