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

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ClinicalTrials.gov Identifier: NCT02101281
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : September 5, 2017
Sponsor:
Collaborator:
Cross Research S.A.
Information provided by (Responsible Party):
Dompé Farmaceutici S.p.A

Brief Summary:
The purpose of the study is to assess the efficacy and safety of different doses of rhNGF when administered as eye drops to patients with Dry Eye.

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Biological: Human nerve growth factor 20 µg/mL Biological: Human nerve growth factor 4 µg/mL or 60 µg/mL Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 20, 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
20 patients will be treated with the first planned dose, i.e. 20 µg/mL
Biological: Human nerve growth factor 20 µg/mL
1 drop for each eye, twice daily for 28 day
Other Name: rhNGF

Experimental: Group 2
After completion of Group 1 treatment, data on primary efficacy and safety variables will be reviewed to identify the appropriate dose for Group 2
Biological: Human nerve growth factor 4 µg/mL or 60 µg/mL
either 4 µg/mL, option 1 or 60 µg/mL, option 2; 1 drop each eye, twice daily for 28 day
Other Name: rhNGF




Primary Outcome Measures :
  1. Symptom Assessment in Dry Eye (SANDE) [ Time Frame: Changes from baseline up to day 56±4 ]
  2. Ocular surface vital staining [ Time Frame: Changes from baseline up to day 56±4 ]
  3. Schirmer test type I [ Time Frame: Changes from baseline up to day 56±4 ]
  4. Treatment-emergent adverse events (TEAEs), [ Time Frame: Changes from baseline up to day 56±4 ]

Secondary Outcome Measures :
  1. Visual analogue scale (VAS) [ Time Frame: Changes from baseline up to day 56±4 ]
  2. Slit lamp examination [ Time Frame: Changes from baseline up to day 56±4 ]
  3. Schirmer test type II (with anaesthesia) [ Time Frame: Changes from baseline up to day 56±4 ]
  4. Tear Film Break-Up Time (TFBUT) [ Time Frame: Changes from baseline up to day 56±4 ]
  5. Corneal fluorescein staining [ Time Frame: Changes from baseline up to day 56±4 ]
  6. Corneal sensitivity (Cochet-Bonnet aesthesiometry) [ Time Frame: Changes from baseline up to day 56±4 ]
  7. Intraocular Pressure (IOP) [ Time Frame: Changes from baseline up to day 56±4 ]
  8. Ocular Surface Disease Index (OSDI) [ Time Frame: Changes from baseline up to day 56±4 ]
  9. Visual acuity [ Time Frame: Changes from baseline up to day 56±4 ]
  10. Fundus ophthalmoscopy [ Time Frame: Changes from baseline up to day 56±4 ]
  11. Tear Film osmolarity [ Time Frame: Changes from baseline up to day 56±4 ]
  12. Conjunctival impression cytology for goblet cells' count Tear Film osmolarity [ Time Frame: Changes from baseline up to day 56±4 ]
  13. Frequency of artificial tears use [ Time Frame: Changes from day 1 to 56±4 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02101281


Locations
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Austria
Department of Clinical Pharmacology
Wien, Austria, 1090
Sponsors and Collaborators
Dompé Farmaceutici S.p.A
Cross Research S.A.
Investigators
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Principal Investigator: Gerhard Garhöfer, MD Medical University of Vienna, Vienna General Hospital, AKH

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Responsible Party: Dompé Farmaceutici S.p.A
ClinicalTrials.gov Identifier: NCT02101281     History of Changes
Other Study ID Numbers: NGF0213
2013-004271-12 ( EudraCT Number )
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: July 2015

Keywords provided by Dompé Farmaceutici S.p.A:
Dry Eye

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Mitogens
Ophthalmic Solutions
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmaceutical Solutions