Dry Eye syndrome is caused by either decreased tear production or increased tear film evaporation. Dry eye is a chronic inflammatory condition of the ocular surface with severe symptoms and visual impairment, leading to worse efficiency to perform duties MedDRA version: 16.1 Level: LLT Classification code 10013777 Term: Dry eye syndrome System Organ Class: 100000004853
Conditions
Interventions
Product Name: Recombinant human nerve growth factor
Product Code: rhNGF
Pharmaceutical Form: Ear/eye drops, solution
INN or Proposed INN: Recombinant Human Nerve Growth Factor
Other descriptive name:
Sponsors
Dompé s.p.a
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients, = 18 years old; 2. Required use of artificial tears for the treatment of Dry Eye within the 3 months prior to study enrolment; 3. Current use or recommended use of artificial tears for the treatment of Dry Eye; 4. Average VAS scores for typical symptoms of Dry Eye (foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) = 25 mm; 5. Corneal staining score > 3 using the NEI corneal grading system in the worse eye (study eye); 6. Conjunctival staining score > 3 using the NEI conjunctival grading system in the worse eye (study eye); 7. Schirmer test without anaesthesia = 10 mm/5 minutes in the worse eye (study eye); 8. Tear film break-up time (TFBUT) = 10 seconds in the worse eye (study eye). 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient not suitable to participate in the study in the opinion of the investigator; 2. Patient with a mild or moderate Dry Eye condition (severity level less than 3 according to the Report of the International Dry Eye Workshop -DEWS, 2007) if fourteen (14) patients with mild or moderate dry eye condition have been already enrolled in the current treatment group (Group 1 and Group 2 separately); 3. Patient has had a serious adverse reaction or significant hypersensitivity to any drug or chemically related compounds or has a clinically significant allergy to drugs, foods, amide local anaesthetics or other materials including commercial artificial tears containing Hypromellose (in the opinion of the investigator); 4. Use of topical cyclosporine, topical corticosteroids or any other topical medication for the treatment of dry eye in either eye within 30 days of study enrolment. Use of own artificial tears is allowed until Visit 2; 5. Any ocular disease other than Dry Eye requiring treatment with topical medications in either eye within 30 days of study enrolment; 6. Any active ocular infection or active inflammation in either eye unrelated to Dry Eye; 7. Presence or history of any systemic or ocular disorder, condition or disease that could possibly interfere with the conduct of the required study procedures or the interpretation of the study results; 8. Use of therapeutic or Refractive Contact lenses in either eye within 30 days of study enrolment; 9. History of ocular surgery in the study eye, including corneal refractive procedures, within 90 days of study enrolment; 10. Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions: a. are currently pregnant or, b. have a positive result at the urine pregnancy test (screening/Day 1) or, c. intend to become pregnant during the study treatment period or, d. are breast-feeding or, e. are not willing to use highly effective birth control measures, such as: hormonal contraceptives - oral, implanted, transdermal, or injected - and/or mechanical barrier methods - spermicide in conjunction with a barrier such as a condom or diaphragm or IUD - during the entire course of and 30 days after the study treatment periods. 11. Participation in another clinical study at the same time as the present and within 30 days of study enrolment; 12. History of drug, medication or alcohol abuse or addiction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the efficacy and safety of different doses of rhNGF when administered as eye drops to patients with Dry Eye. on the basis of the following assessments: - Symptom Assessment in Dry Eye (SANDE) - Ocular surface vital staining (National Eye Institute [NEI] scales) - Schirmer test type I (without anaesthesia) performed on days 1, 8±1, 29±1 and 56±4. Changes from baseline (screening visit) will be evaluated. - Treatment-emergent adverse events (TEAEs), assessed throughout the study;Secondary Objective: Evaluation of the clinical efficacy and safety during and at the end of treatment with rhNGF, on the basis of the following assessments: - Visual analogue scale (VAS) for (foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) - Slit lamp examination (Eyelid - Meibomian glands, Eyelid – Erythema, Eyelid - Oedema Lashes, Conjunctiva Erythema, Lens, Iris, Anterior Chamber) - Schirmer test type II (with anaesthesia) - Tear Film Break-Up Time (TFBUT) - Corneal sensitivity (Cochet-Bonnet aesthesiometry) - Intraocular Pressure (IOP) - Ocular Surface Disease Index (OSDI) - Visual acuity - Fundus ophthalmoscopy - Tear Film osmolarity - Conjunctival impression cytology for goblet cells' count - Frequency of artificial tears use performed on days 1, 8±1, 29±1 and 56±4. Changes from baseline (screening visit) will be evaluated. - Vitals signs, body weight (BW), physical examinations.;Primary end point(s): Evaluation of the clinical efficacy and safety during and at the end of treatment with rhNGF, on the basis of the following assessments: - Symptom Assessment in Dry Eye (SANDE) - Ocular surface vital staining (National Eye Institute [NEI] scales) - Schirmer test type I (without anaesthesia) performed on days 1, 8±1, 29±1 and 56±4. Changes from baseline (screening visit) will be evaluated. - Treatment-emergent adverse events (TEAEs), assessed throughout the study;Tim | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Study end-points, continued: Secondary end-points: Evaluation of the clinical efficacy and safety during and at the end of treatment with rhNGF, on the basis of the following assessments: - Visual analogue scale (VAS) for (foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) - Slit lamp examination (Eyelid - Meibomian glands, Eyelid –Erythema, Eyelid - Oedema Lashes, Conjunctiva Erythema, Lens, Iris, Anterior Chamber) - Schirmer test type II (with anaesthesia) - Tear Film Break-Up Time (TFBUT) - Corneal sensitivity (Cochet-Bonnet aesthesiometry) - Intraocular Pressure (IOP) - Ocular Surface Disease Index (OSDI) - Visual acuity (Early Treatment Diabetic Retinopathy Study [ETDRS] chart) - Fundus ophthalmoscopy - Tear Film osmolarity - Conjunctival impression cytology for goblet cells' count - Frequency of artificial tears use performed on days 1, 8±1, 29±1 and 56±4. Changes from baseline (screening visit) will be evaluated. - Vitals signs (blood pressure; BP, pulse rate; PR), body weight (BW), physical examinations.;Timepoint(s) of evaluation of this end point: days 1, 8±1, 29±1 and 56±4 | — |
Countries
Austria
Contacts
Public ContactMedical Expert
Dompé spa
Outcome results
None listed