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

NCT ID: NCT02101281

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-20
• Study Completion Date: 2015-01-31

Brief 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.

Detailed 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

Conditions

Dry Eye Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 - rhNGF 20 μg/mL

(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.

Group Type: EXPERIMENTAL

rhNGF 20 µg/mL

Intervention Type: DRUG

1 drop for each eye, twice daily for 28 day

Group 2 - rhNGF 4 μg/mL

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.

Group Type: EXPERIMENTAL

rhNGF 4 µg/mL

Intervention Type: DRUG

1 drop each eye, twice daily for 28 day

Interventions

rhNGF 20 µg/mL

1 drop for each eye, twice daily for 28 day

Intervention Type: DRUG

rhNGF 4 µg/mL

1 drop each eye, twice daily for 28 day

Intervention Type: DRUG

Other Intervention Names

cenegermin, recombinant human Nerve Growth Factor; cenegermin, recombinant human Nerve Growth Factor

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cross Research S.A.

INDUSTRY

Sponsor Role: collaborator

Dompé Farmaceutici S.p.A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerhard Garhöfer, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Vienna General Hospital, AKH

Locations

Department of Clinical Pharmacology

Vienna, , Austria

Countries

Austria

References

Sacchetti M, Lambiase A, Schmidl D, Schmetterer L, Ferrari M, Mantelli F, Allegretti M, Garhoefer G. Effect of recombinant human nerve growth factor eye drops in patients with dry eye: a phase IIa, open label, multiple-dose study. Br J Ophthalmol. 2020 Jan;104(1):127-135. doi: 10.1136/bjophthalmol-2018-312470. Epub 2019 Apr 3.

Reference Type: DERIVED

PMID: 30944103 (View on PubMed)

Other Identifiers

2013-004271-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NGF0213

Identifier Type: -

Identifier Source: org_study_id