An open-label study evaluating safety and efficacy of recombinant human nerve growth factor (rhNGF) eye drops at different doses in patients with Dry Eye

• Conditions: 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: 16.1Level: LLTClassification code 10013777Term: Dry eye syndromeSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2013-004271-12-AT
• Lead Sponsor: Dompé s.p.a

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-14
• Last Update Posted: 16 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified