Overview

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

Status:
Unknown status
Trial end date:
2018-12-01
Target enrollment:
0
Participant gender:
All
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):
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Avizorex Pharma
Avizorex Pharma, S.L.
Treatments:
Ophthalmic Solutions
Pharmaceutical Solutions
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.