Safety and Efficacy of rhNGF Eye Drops at Different Doses in Patients With Dry Eye
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: rhNGF 20 µg/mL; rhNGF 4 µg/mL
Intervention description: 1 drop for each eye, twice daily for 28 day; 1 drop each eye, twice daily for 28 day
Intervention MeSH terms: Mitogens
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dry Eye

Summary:

      The primary objective of this study was to assess the efficacy and safety of different doses
      of rhNGF when administered as eye drops to patients with dry eye.
    

Eligibility 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 score 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 with lissamine green > 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 (TBUT) ≤ 10 seconds in the worse eye (study eye);

          9. A negative urine pregnancy test if female of childbearing potential and must use
             adequate birth control throughout the study period

        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. Participation in another clinical study at the same time as the present and within 30
             days of study enrolment;

         11. History of drug, medication or alcohol abuse or addiction.