patients after cataract and refractive surgery MedDRA version: 20.0 Level: SOC Classification code 10015919 Term: Eye disorders System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: rhNGF
Product Code: rhNGF
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: NERVE GROWTH FACTOR (NGF), RICOMBINANTE UMANO
CAS Number: 1772578-74-1
Current Sponsor code: rhNGF
Sponsors
DOMPé FARMACEUTICI S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female =18 years old 2. Patients who are characterized by the following clinical features: a. History of cataract or refractive corneal surgery in the study eye in the previous 6 months; b. Mean Symptom Assessment in Dry Eye (SANDE) score for severity and frequency of at least 30 at baseline 3. The same eye (study eye) must fulfill all the above criteria 4. Best corrected distance visual acuity (BCDVA) score of = 0.1 decimal units in both eyes at the time of study enrolment 5. Female patients must have negative pregnancy urine test if at childbirth potential. 6. Only patients who satisfy all requirements for informed consent may be included in the study. Written Informed Consent must be obtained before the initiation of any study-specific procedures. 7. Patients must have the ability and willingness to comply with study procedures. Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: 1. Any ocular disease other than Dry Eye requiring treatment with topical medications in either eye at the time of study enrolment. 2. Any active ocular infection or active inflammation in either eye unrelated to Dry Eye. 3. 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. 4. Use of therapeutic or Refractive Contact lenses in either eye at the time of study enrolment; 5. History of ocular surgery in the study eye, excluding corneal refractive or cataract procedures, within 90 days of study enrolment. 6. 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 (Baseline/Day 0) 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. 7. Participation in another clinical study at the same time as the present and within 30 days of study enrolment; 8. 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 efficacy and safety of rhNGF when administered as eye drops to patients after cataract and refractive surgery.;Secondary Objective: NA;Primary end point(s): Change from baseline in SANDE scores for severity and frequency assessed at 8 weeks of treatment ;Timepoint(s) of evaluation of this end point: This endpoint will be evaluated at each time point (days 0, 28±2, 56±2 and 28±2 days after discontinuation of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in SANDE scores (face values) for severity and frequency;Timepoint(s) of evaluation of this end point: (days 0, 28±2, 56±2 and 28±2 days after discontinuation of treatment) | — |
Countries
Italy
Contacts
Public ContactCLINICAL DEVELOPMENT
DOMPE' FARMACEUTICI SPA
Outcome results
None listed