A 8 weeks, Phase II, single-centre, randomized, double-masked, vehicle-controlled, parallel group study with 4 weeks of follow-up to evaluate preliminary efficacy and safety of recombinant human Nerve Growth Factor (rhNGF) eye drops solution versus vehicle in patients after cataract and refractive surgery.
- Conditions
- patients after cataract and refractive surgeryMedDRA version: 20.0Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2016-002172-27-IT
- Lead Sponsor
- DOMPé FARMACEUTICI S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)