Safety and Efficacy of rhNGF Eye Drops at Different Doses in Patients With Dry Eye

Dompé

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndrome

Treatments: Drug: rhNGF 20 µg/mL; Drug: rhNGF 4 µg/mL

Study type: Interventional

Funder types: Industry

Identifiers

NCT02101281

2013-004271-12 (EudraCT Number)

NGF0213

Details and patient eligibility

About

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.

Full description

This is 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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Group 1 - rhNGF 20 μg/mL

Experimental group

Description:

(first planned dose): drop (35 μL) corresponding to 0.70 μg of rhNGF (recombinant human Nerve Growth Factor) was instilled into each eye twice a day (b.i.d.) every 12±2 h for a total daily dose of 2.8 μg (both eyes), for 28 consecutive days. The total dose was 78.4 μg/28 days.

Treatment:

Drug: rhNGF 20 µg/mL

Group 2 - rhNGF 4 μg/mL

Experimental group

Description:

after completion of Group 1 treatment, one drop (35 μL) corresponding to 0.14 μg of rhNGF (recombinant human Nerve Growth Factor) instilled into each eye b.i.d. every 12±2 h for a total daily dose of 0.56 μg, for 28 consecutive days. Total dose was 15.68 μg/28 days.

Treatment:

Drug: rhNGF 4 µg/mL