Dry eye syndrome MedDRA version: 20.0 Level: LLT Classification code 10013777 Term: Dry eye syndrome System Organ Class: 100000004853
Conditions
Interventions
Product Code: AVX-012
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: AVX-012 Ophthalmic Solution
CAS Number: AVX012001
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Sponsors
AVIZOREX PHARMA, S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be included in the study if all of the following criteria are met: 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 172 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria will be defined ensuring that both ophthalmic and systemic criteria disqualify inappropriate subjects from inclusion in the clinical study. Patients will be excluded for participating in this study if 1 or more of the following criteria are met: •Ophthalmic criteria: 1.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). 2.Best-corrected visual acuity score of 55 letters read or lower in each eye as measured by ETDRS (letters read method). 3.Any hypersensitivity to the use of the study product formulations or an allergy to any ingredient(s) contained within product formulations or products required while participating in the study, such as sodium fluorescein. 4.Intraocular, strabismus, or palpebral surgery or surgery in the orbit or glaucoma laser surgery within the previous 6 months. 5.History of refractive surgery in either eye (e.g., radial keratotomy, PRK, LASIK, etc.). 6.Ocular trauma within the past 6 months. 7.Ocular surgery or laser treatment within the past 3 months. 8.Evidence of ocular abnormalities in either eye that could adversely affect the safety or efficacy outcome such as: ? Eyelid anomalies that affect proper lid closure or proper blink function (e.g., ectropion or entropion). ? Corneal disorders or abnormality such as active corneal ulcer, current corneal abrasion, keratoconus, or corneal dystrophies which are actively changing or affect vision. ? Metaplasia of the ocular surface. ? Current filamentous keratitis. ? Evidence of corneal neovascularization. ? Any history of herpes simplex or herpes zoster keratitis. ? Ocular infection (bacterial, viral, or fungal), inflammation not associated with dry eye such as uveitis, iritis, active blepharitis, active allergic conjunctivitis, etc., cystoid macular edema. 9.Ocular medication of any kind, with the exception of artificial tears/gels/lubricants within the past 2 weeks of screening. Note: a minimum 90-day washout period from use of Restasis® or Ikervis® will be required. 10.Use of systemic medication that might cause dryness in the eye as a secondary effect (such as antihistaminics, hormone replacing therapies, etc.). 11.Contact lens use within 2 weeks prior to screening visit and/or unwilling to avoid contact lens use during the course of the study. 12.Unwilling to avoid use of additional artificial tears (other than study treatments) throughout the study, starting at screening visit. 13.Participation in an investigational drug or device trial within the 30 days previous to screening visit. 14.Any abnormality preventing reliable applanation tonometry of either eye. 15.Central corneal thickness gr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Part B of the study: Confirm the safety of AVX-012 ophthalmic solution in subjects with dry eye syndrome. Assess the efficacy of AVX-012 ophthalmic solution in terms of corneal staining, Schirmer I test, tear film break up time, and conjunctival staining findings. ; Primary end point(s): Study part A: The primary endpoint for the study part A will be the percentage of patients with adverse events from baseline (treatment period and post-treatment safety follow-up). They will include adverse events reported over the medical interview or evidenced on any of the following assessments: * Vital signs: systolic blood pressure, diastolic blood pressure, and heart rate. * Laboratory analyses: • Hematology: hemoglobin, hematocrit, erythrocyte count, leukocyte count, and platelet count. • Biochemistry: glucose, creatinine, bilirubin, aspartate transferase (AST), alanine transferase (ALT), gamma glutamyl transferase (GGT), total cholesterol, sodium, and potassium. • Urine pregnancy test, for women of childbearing potential. * Best-corrected visual acuity (ETDRS) * Corneal anesthesia (Cochet-Bonnet) * Intraocular pressure * Biomicroscopy/staining (fluorescein), and ophthalmoscopy (dilated). An independent safety committee will be in charge of assessing the tolerability of study treatments to proceed to part B. Study part B The primary endpoint for the study part B will be the 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). ; Timepoint(s) of evaluation of this end point: Part A Safety endpoints will be collected: | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Study part B Secondary endpoints will include: • The 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). • Changes in corneal staining, Shirmer I test, tear film break up time, and conjunctival staining over the study treatment according to the different dosing frequencies (TID and BID). ; Timepoint(s) of evaluation of this end point: Study part B Secondary endpoints will be collected: •AEs, changes in corneal staining and conjunctival staining: - Screening visit (visit 0) - Visits over the treatment period: visit 1, visit 2, visit 3 and visit 4 - Post-treatment safety follow-up (visit 5) •Shirmer I test and tear film break up time: - Screening visit (visit 0) - Visits over the treatment period: visit 1, visit 2, visit 3 and visit 4 | — |
Countries
Spain
Contacts
Public ContactClinical Trials Information
AVIZOREX PHARMA, S.L.
Outcome results
None listed