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Dry Eye SyndromePhase 2NCT03982368

A Study to Evaluate Safety and Efficacy of rhNGF Eye Solution vs Vehicle in Patients With Moderate to Severe Dry Eye

A Phase 2 study testing rhNGF 20 μg/ml in people with Dry Eye Syndrome, run by Dompé Farmaceutici S.p.A at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to assess the efficacy and safety of rhNGF eye drops at 20 μg/ml concentration administered two or three times daily for 4 weeks in patients with moderate to severe dry eye. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Dry Eye Syndrome
What is being tested?
rhNGF 20 μg/ml
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
261 participants
Where
12 sitesUnited States
Study dates
10 Jun 2019to 15 Jul 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female aged ≥ 18 years
  • Patients with moderate to severe dry eye characterized by the following clinical features:
  • Corneal and/or conjunctival staining with fluorescein using National Eye Institute (NEI) grading system > 3
  • SANDE questionnaire >25 mm
  • Schirmer test I (without anaesthesia) >2mm <10 mm/5 minutes
  • Tear film break-up time (TFBUT) < 10 seconds in the worse eye
Show all 12Show fewer
  • The same eye (eligible eye) must fulfill all the above criteria
  • Patients diagnosed with dry eye at least 6 months before enrolment (current use or recommended use of artificial tears for the treatment of Dry Eye)
  • Best corrected distance visual acuity (BCDVA) score of ≥ 0.1 decimal units (20/200 Snellen value) in both eyes at the time of study enrolment
  • If a female of childbearing potential, have a negative pregnancy test
  • Only patients who satisfy all Informed Consent requirements may be included in the study. The patient and/or his/her legal representative must read, sign and date the Informed Consent document before any study-related procedures are performed. The Informed Consent form signed by patients and/or legal representative must have been approved by the Institutional Review Board (IRB) / Independent Ethics Committee (IEC) for the current study
  • Patients must have the ability and willingness to comply with study procedures.

Who cannot join

  • Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments;
  • Evidence of an active ocular infection, in either eye
  • Presence of any other ocular disorder or condition requiring topical medication during the entire duration of study
  • History of severe systemic allergy or of ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis and/or keratitis other than dry eye
  • Intraocular inflammation defined as Tyndall score >0
  • History of malignancy in the last 5 years
Show all 21Show fewer
  • Systemic disease not stabilized within 1 month before Screening Visit (e.g. diabetes with glycemia out of range, thyroid malfunction..) or judged by the investigator to be incompatible with the study (e.g. current systemic infections) or with a condition incompatible with the frequent assessment required by the study
  • Patient had a serious adverse reaction or significant hypersensitivity to any drug or chemically related compounds or had a clinically significant allergy to drugs, foods, amide local anaesthetics or other materials including commercial artificial tears (in the opinion of the investigator)
  • 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:
  • are currently pregnant or,
  • have a positive result at the urine pregnancy test (Baseline/Day 0) or,
  • intend to become pregnant during the study treatment period or,
  • are breast-feeding or,
  • 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 Intra Uterine Device (IUD) - during the entire course of and 30 days after the study treatment periods
  • Any concurrent medical condition, that in the judgment of the PI, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient's well-being
  • Use of topical cyclosporine, topical corticosteroids or any other topical drug for the treatment of dry eye in either eye within 30 days of study enrolment.
  • Contact lenses or punctum plug use during the study (previous use not an exclusion criteria but must be discontinued at the screening visit)
  • History of drug addiction or alcohol abuse
  • Any prior ocular surgery (including refractive palpebral and cataract surgery) if within 90 days before the screening visit
  • Participation in a clinical trial with a new active substance during the past 6 months
  • Participation in another clinical trial study at the same time as the present study.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • SightMD

    Babylon, New York, 11702

  • Global Research Management

    Glendale, California, 91204

  • Houston Eye Associates HEA - Gramercy Location

    Houston, Texas, 77025

  • Advanced Laser Vision Surgical Institute (Study Site) Intouch Clinical Research Center (SMO)

    Houston, Texas, 77034

  • Tauber Eye Center

    Kansas City, Missouri, 64111

  • Moyes Eye Center

    Kansas City, Missouri, 64154

  • Kentucky Eye Institute

    Lexington, Kentucky, 40517

  • Clayton Eye Clinical Research, LLC

    Morrow, Georgia, 30260

  • Toyos Clinic

    Nashville, Tennessee, 37027

  • Eye Research Foundation

    Newport Beach, California, 92663

  • Martel Eye Medical Group

    Rancho Cordova, California, 95670

  • Sierra Clinical Trials & Research Organization

    Santa Ana, California, 92647

Other trials in United States

About this study

Official title: A 4 Weeks, Phase II, Multicenter, Randomized, Double-masked, Vehicle-controlled, Parallel Group Study With 12 Weeks of Follow-up to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution vs Vehicle in Moderate to Severe Dry Eye.

The objective of this study is to assess the efficacy and safety of rhNGF eye drops at 20 μg/ml concentration administered two or three times daily for 4 weeks in patients with moderate to severe dry eye.

Read the detailed description

This is a 4 weeks, Phase II, multicenter, randomized, double-masked, vehicle-controlled, parallel group study with 12 weeks of follow-up, designed to perform dose-ranging and to evaluate safety and efficacy of recombinant human Nerve Growth Factor (rhNGF) eye drops solution versus vehicle, in patients with moderate to severe dry eye (DE).

Test product is rhNGF 20 μg/ml; reference product is vehicle. Test and reference will be instilled in both eyes according to the following scheme:

Group 1: one drop of rhNGF 20 μg/ml is instilled in both eyes three times daily (every 6-8 hours, e.g. 7:00 am, 02:00 pm; 09:00 pm).

Group 2: one drop of rhNGF 20 μg/ml is instilled in both eyes two times daily (in the morning and in the evening) plus one drop (40 μL) of vehicle (placebo) is instilled in both eyes once daily in the afternoon.

Group 3: one drop (40 μL) of vehicle (placebo) is instilled in both eyes three times daily (every 6-8 hours, e.g. 7:00 am, 02:00 pm; 09:00 pm).

Approximate randomization 1:1:1 of 261 patients to rhNGF eye drops solution 20 μg/ml TID (87 patients) or rhNGF eye drops solution 20 μg/ml BID + vehicle eye drop SID (86 patients) or vehicle eye drops solution (88 patients) TID for 4 weeks was applied.

Being tested
rhNGF 20 μg/ml, rhNGF 20 μg/ml + vehicle, Vehicle
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rhNGF 20 μg/mlDrug

    Also called cenegermin

    one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)

  • rhNGF 20 μg/ml + vehicleDrug

    Also called cenegermin + placebo

    one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).

    rhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon.

  • VehicleOther

    Also called placebo

    one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)

Study groups in NCT03982368
Study groupRoleWhat they receive
rhNGF 20 μg/ml TIDExperimentalOne drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)
Receives: Drug: rhNGF 20 μg/ml
rhNGF 20 μg/ml BID + vehicle ODExperimentalOne drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily (BID) plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (OD) (every 6-8 hours)
Receives: Drug: rhNGF 20 μg/ml + vehicle
Vehicle TIDPlacebo comparatorVehicle eye one drop will be instilled in both eyes three times daily (every 6-8 hours)
Receives: Other: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Schirmer I Test (Without Anesthesia) vs Week 4 - Full Analysis Set

    The Schirmer test is used in ophthalmic examination to measure tear production for the diagnosis of conditions such as keratoconjunctivitis sicca and dry eye.

    Without previously instilling anesthetic drops, the Schirmer strip is inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes.

    The patients will be instructed to close their eyes gently. After 5 minutes have elapsed, the Schirmer test strip will be removed and the length of the tear absorption on the strip will be measured (millimeters/5 minutes)

    Cutoff values:

    <5 mm - pathologic dry eye 5-10 mm - marginal dry eye >10 and <30 mm - normal secretion

    Measured: Baseline, week 4

  2. Change From Baseline in Schirmer I Test (Without Anesthesia) vs Week 4 - Per Protocol Set

    The Schirmer test is used in ophthalmic examination to measure tear production for the diagnosis of conditions such as keratoconjunctivitis sicca and dry eye.

    Without previously instilling anesthetic drops, the Schirmer strip is inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes.

    The patients will be instructed to close their eyes gently. After 5 minutes have elapsed, the Schirmer test strip will be removed and the length of the tear absorption on the strip will be measured (millimeters/5 minutes)

    Cutoff values:

    <5 mm - pathologic dry eye 5-10 mm - marginal dry eye >10 and <30 mm - normal secretion

    Measured: Baseline, week 4

Secondary outcomes (18)

  1. Change From Baseline in Symptoms Questionnaire (SANDE) Scores for Severity vs Week 4 - Full Analysis Set

    The SANDE (symptom assessment in dry eye) score is composed by two questions presented in visual analog scale. The two questions assess the frequency and severity of dry eye syndrome. The global score is calculated by taking the square root of the product of the severity of symptoms per the frequency of symptoms. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.

    Measured: Baseline, week 4

  2. Change From Baseline in Symptoms Questionnaire (SANDE) Scores for Severity vs Week 4 - Per Protocol Set

    The SANDE (symptom assessment in dry eye) score is composed by two questions presented in visual analog scale. The two questions assess the frequency and severity of dry eye syndrome. The global score is calculated by taking the square root of the product of the severity of symptoms per the frequency of symptoms. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.

    Measured: Baseline, week 4

  3. Change From Baseline in Symptoms Questionnaire (SANDE) Scores for Frequency vs Week 4 - Full Analysis Set

    The SANDE (symptom assessment in dry eye) score is composed by two questions presented in visual analog scale. The two questions assess the frequency and severity of dry eye syndrome.The SANDE global score is calculated by taking the square root of the product of the frequency of symptoms and the severity of symptoms. The SANDE scale ranges from 0 to 100 wi.100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms

    Measured: Baseline, week 4

  4. Change From Baseline in Symptoms Questionnaire (SANDE) Scores for Frequency vs Week 4 - Per Protocol Set

    The SANDE (symptom assessment in dry eye) score is composed by two questions presented in visual analog scale. The two questions assess the frequency and severity of dry eye syndrome. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score. The SANDE scale ranges from 0 to 100 wi.100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.

    Measured: Baseline, week 4

  5. Change From Baseline in Schirmer II Test (With Anesthesia) vs Week 4 - Full Analysis Set

    The Schirmer II test is performed as the Schirmer I test after instilling anesthetic drops. The Schirmer strips are inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes. All patients are seated at rest with their eyes closed, and the lower cul-de-sac is gently dried with a cotton applicator before the placement of strips.

    Cut-off values:

    <5 mm - pathologic dry eye 5-10 mm - marginal dry eye >10 and <30 mm - normal secretion

    Measured: Baseline, week 4

  6. Change From Baseline in Schirmer II Test (With Anesthesia) vs Week 4 - Per Protocol Set

    The Schirmer II test is performed as the Schirmer I test after instilling anesthetic drops. The Schirmer strips are inserted into the lower conjunctival sac at the junction of the lateral and middle thirds, avoiding touching the cornea, and the length of wetting strips in millimeters is recorded after 5 minutes.

    All patients are seated at rest with their eyes closed, and the lower cul-de-sac is gently dried with a cotton applicator before the placement of strips.

    Cut-off values:

    <5 mm - pathologic dry eye 5-10 mm - marginal dry eye >10 and <30 mm - normal secretion

    Measured: Baseline, week 4

  7. Change From Baseline in Corneal and Conjunctiva Vital Staining With Fluorescein (National Eye Institute [NEI] Scales) vs Week 4 - Full Analysis Set

    Corneal staining total score is defined as the sum of scores from 5 corneal areas: Central, Superior, Temporal, Nasal, and Inferior. The score for each area ranges from 0 to 3 where grade 0 reflects normal/healthy situation, whereas grade 3 reflects a severe damage. Thus, the corneal staining total score can range from 0 to 15 where the higher the score the worse is the outcome.

    The conjunctiva is divided into a superior paralimbal area, an inferior paralimbal area and a peripheral area with a grading scale of 0-3 where grade 0 reflects normal/healthy situation, whereas grade 3 reflects a severe damage and with a maximal score of 9 for the nasal and temporal conjunctiva. Thus, the conjunctival staining total score can range from 0 to 18 where the higher the score the worse is the outcome.

    Corneal and conjunctiva vital staining total score is the sum of corneal staining total score and conjunctiva total score.

    Measured: Baseline, week 4

  8. Change From Baseline in Corneal and Conjunctiva Vital Staining With Fluorescein (National Eye Institute [NEI] Scales) vs Week 4 - Per Protocol Set

    Corneal staining total score is defined as the sum of scores from 5 corneal areas: Central, Superior, Temporal, Nasal, and Inferior. The score for each area ranges from 0 to 3 where grade 0 reflects normal/healthy situation, whereas grade 3 reflects a severe damage. Thus, the corneal staining total score can range from 0 to 15 where the higher the score the worse is the outcome.

    The conjunctiva is divided into a superior paralimbal area, an inferior paralimbal area and a peripheral area with a grading scale of 0-3 where grade 0 reflects normal/healthy situation, whereas grade 3 reflects a severe damage and with a maximal score of 9 for the nasal and temporal conjunctiva. Thus, the conjunctival staining total score can range from 0 to 18 where the higher the score the worse is the outcome.

    Corneal and conjunctiva vital staining total score is the sum of corneal staining total score and conjunctiva total score.

    Measured: Baseline, week 4

  9. Change From Baseline in Tear Film Break-Up Time (TFBUT) vs Week 4 - Full Analysis Set

    Tear film break-up time (TFBUT) is the time taken to appear first dry spot on cornea after a complete blinking. TFBUT measurement is an easy and fast method used to assess the stability of tear film. It is a standard diagnostic procedure in the dry eye clinics. TFBUT is measured by determining the time to tear break-up. The TFBUT is performed after instillation of 5 μL of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient is instructed to blink several times to thoroughly mix the fluorescein with the tear film.

    A TFBUT greater than 15 seconds is considered normal, while a break time of less than 10 seconds is to be considered pathological.

    Measured: Baseline, week 4

  10. Change From Baseline in Tear Film Break-Up Time (TFBUT) vs Week 4 - Per Protocol Set

    Tear film break-up time (TFBUT) is the time taken to appear first dry spot on cornea after a complete blinking. TFBUT measurement is an easy and fast method used to assess the stability of tear film. It is a standard diagnostic procedure in the dry eye clinics. TFBUT is measured by determining the time to tear break-up. The TFBUT is performed after instillation of 5 μL of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient is instructed to blink several times to thoroughly mix the fluorescein with the tear film.

    A TFBUT greater than 15 seconds is considered normal, while a break time of less than 10 seconds is to be considered pathological.

    Measured: Baseline, week 4

  11. Number of Patients Who Experienced a Worsening in Symptom Scores (SANDE) and/or NEI Score ≥ 50% Assessed at Week 4 - Full Analysis Set

    The SANDE score is calculated by taking the square root of the product of the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.

    The NEI/Industry Workshop guidelines are used for grading the scale of corneal and conjunctival damage.

    The cornea is divided into five sectors (central, superior, inferior, nasal and temporal), each of which is scored on a scale of 0-3, with a maximal total corneal staining score of 15.

    Both nasally and temporally, the conjunctiva is divided into a superior paralimbal area, an inferior paralimbal area, and a peripheral area with a grading scale of 0-3 and with a maximal total score of 9 for the nasal and temporal conjunctiva (overall the total score ranged from 0-18).

    Briefly, grade 0 reflects normal/healthy situation, whereas grade 3 reflects a severe damage in the considered sector.

    Measured: At week 4

  12. Number of Patients Who Experienced a Worsening in Symptom Scores (SANDE) and/or NEI Score ≥ 50% Assessed at Week 4 - Per Protocol Set

    The SANDE score is calculated by taking the square root of the product of the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.

    The NEI/Industry Workshop guidelines are used for grading the scale of corneal and conjunctival damage.

    The cornea is divided into five sectors (central, superior, inferior, nasal and temporal), each of which is scored on a scale of 0-3, with a maximal total corneal staining score of 15.

    Both nasally and temporally, the conjunctiva is divided into a superior paralimbal area, an inferior paralimbal area, and a peripheral area with a grading scale of 0-3 and with a maximal total score of 9 for the nasal and temporal conjunctiva (overall the total score ranged from 0-18).

    Briefly, grade 0 reflects normal/healthy situation, whereas grade 3 reflects a severe damage in the considered sector.

    Measured: At week 4

  13. Change From Baseline in Quality of Life (Impact of Dry Eye on Everyday Life (IDEEL) Questionnaire vs Different Timepoints - Full Analysis Set

    IDEEL assesses quality of life, symptoms and treatment effects on patients with dry eye.

    The IDEEL contains 3 modules (Daily Activities, Treatment Satisfaction, and Symptom Bother) with a total of 57 questions.

    1. The Daily Activities Module is the quality of life instrument. It is comprised of 27 items.
    2. The IDEEL Treatment Satisfaction and Bother Module is divided into 2 sections, Treatment - In General and Treatment - Eye Drops.
    3. The Symptom Bother Module consists of 20 items in a single content domain, Symptom Bother.

    Scores for each dimensions ranged from 0 to 100.

    Higher scores for:

    • dimension of the Dry Eye Impact on Daily Life module indicates less impact on daily activities;
    • symptom-bother dimension indicates greater bother due to symptoms;
    • satisfaction with Treatment Effectiveness dimension indicates greater satisfaction with treatment effectiveness;
    • treatment-related bother/inconvenience indicates less treatment-related bother or inconvenience.

    Measured: At weeks 4, 8, 12 and 16

  14. Change From Baseline in Quality of Life (Impact of Dry Eye on Everyday Life (IDEEL) Questionnaire vs Different Timepoints - Per Protocol Set

    IDEEL assesses quality of life, symptoms and treatment effects on patients with dry eye.

    The IDEEL contains 3 modules (Daily Activities, Treatment Satisfaction, and Symptom Bother) with a total of 57 questions.

    1. The Daily Activities Module is the quality of life instrument. It is comprised of 27 items.
    2. The IDEEL Treatment Satisfaction and Bother Module is divided into 2 sections, Treatment - In General and Treatment - Eye Drops.
    3. The Symptom Bother Module consists of 20 items in a single content domain, Symptom Bother.

    Scores for each dimensions ranged from 0 to 100.

    Higher scores for:

    • dimension of the Dry Eye Impact on Daily Life module indicates less impact on daily activities;
    • symptom-bother dimension indicates greater bother due to symptoms;
    • satisfaction with Treatment Effectiveness dimension indicates greater satisfaction with treatment effectiveness;
    • treatment-related bother/inconvenience indicates less treatment-related bother or inconvenience.

    Measured: At weeks 4, 8, 12 and 16

  15. Patient Global Impression of Change (PGIC) - Full Analysis Set

    PGIC is a commonly used method of assessing clinically important change. With PGIC the qualitative assessment of meaningful change is determined by the patient on 7-items using a 0 (very much improved) to 10 (very much worse) scale.

    Measured: At baseline and weeks 4, 8, 12 and 16

  16. Patient Global Impression of Change (PGIC) - Per Protocol Set

    PGIC is a commonly used method of assessing clinically important change. With PGIC the qualitative assessment of meaningful change is determined by the patient on 7-items using a 0 (very much improved) to 10 (very much worse) scale.

    Measured: At weeks 4, 8, 12 and 16

  17. Change From Baseline in EQ-5D-3L Questionnaire to Different Timepoints - Full Analysis Set

    EQ-5D is a standardised measure of health status. - The EQ-5D 3 level version (EQ-5D-3L) consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS) which are summed up.

    The EQ-5D-3L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. This scale ranges from 5 (best case) to 15 (worst case).

    Each dimension has 3 levels: no problems, some problems, extreme problems (labelled 1-3). The respondent must indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.

    • The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This is a quantitative measure of health outcome, judged by each respondent.

    Both for total and partial scores, the higher the score, the worse is the outcome.

    Measured: At weeks 4, 8, 12 and 16

  18. Change From Baseline in EQ-5D-3L Questionnaire to Different Timepoints - Per Protocol Set

    EQ-5D is a standardised measure of health status. - The EQ-5D 3 level version (EQ-5D-3L) consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS) which are summed up.

    The EQ-5D-3L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. This scale ranges from 5 (best case) to 15 (worst case).

    Each dimension has 3 levels: no problems, some problems, extreme problems (labelled 1-3). The respondent must indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.

    • The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This is a quantitative measure of health outcome, judged by each respondent.

    Both for total and partial scores, the higher the score, the worse is the outcome.

    Measured: Aat baseline and weeks 4, 8, 12 and 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2019
  2. Study start10 Jun 2019
  3. Primary completion15 Jul 2020
  4. Study completion15 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
261 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03982368
Sponsor's protocol ID
NGF0118
Status last verified
Dec 2023
First submitted
23 May 2019
Last updated
19 Apr 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Wirta D, Lipsky W, Toyos M, Martel J, Goosey J, Verachtert A, El-Harazi S, Karpecki P, Allegretti M, Goisis G, Pasedis G, Mantelli F. Recombinant human nerve growth factor (cenegermin) for moderate-to-severe dry eye: phase II, randomized, vehicle-controlled, dose-ranging trial. BMC Ophthalmol. 2024 Jul 17;24(1):290. doi: 10.1186/s12886-024-03564-w.

    PubMed 39020305

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rhNGF 20 μg/ml in people with Dry Eye Syndrome, run by Dompé Farmaceutici S.p.A at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Schirmer I Test (Without Anesthesia) vs Week 4 - Full Analysis Set (time frame: Baseline, week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03982368, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.

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