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Study on the Safety and Effectiveness of Cenegermin Eye Drops for Patients with Dry Eye Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Dry Eye Disease, a condition where the eyes do not produce enough tears or the tears evaporate too quickly, leading to discomfort and vision problems. The study will test a new treatment using eye drops containing Recombinant Human Nerve Growth Factor (rhNGF) at two different concentrations. These eye drops are designed to help improve the symptoms of dry eye by promoting healing and reducing inflammation in the eyes.

The purpose of the study is to evaluate the safety and effectiveness of these new eye drops compared to a placebo, which is a substance with no active medication. Participants will be randomly assigned to receive either the rhNGF eye drops or the placebo. The study will last for a total of eight weeks, with the first four weeks involving the use of the eye drops and the following four weeks for observation and follow-up. During the study, participants will have regular check-ups to monitor their eye health and any changes in their symptoms.

In addition to the rhNGF eye drops, the study will also use other substances like Fluorescein Sodium, Calcium Chloride, Potassium Chloride, Sodium Chloride, and Tropicamide for various assessments and procedures. These substances are commonly used in eye examinations to help doctors see the surface of the eye more clearly and to measure tear production. The study aims to determine if the new eye drops can provide better relief from dry eye symptoms compared to the placebo, ultimately improving the quality of life for those affected by this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the trial's objectives and procedures. The patient must have a confirmed diagnosis of dry eye disease for at least six months and meet specific clinical criteria.
The patient will be required to provide informed consent, confirming understanding and agreement to participate in the study.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate the patient's eligibility based on the study's inclusion criteria. This includes a questionnaire to assess symptoms, a Schirmer-I test to measure tear production, and an eye examination to evaluate corneal and conjunctival staining.
Step 3
Treatment phase
The patient will be randomly assigned to receive one of two concentrations of the rhNGF eye drop solution or a placebo. The concentrations are 5 mcg/mL and 10 mcg/mL.
The eye drops will be administered for a period of 4 weeks. The patient will apply the eye drops as instructed, typically several times a day, depending on the specific dosage regimen provided.
Step 4
Follow-up assessments
Follow-up assessments will occur at week 4 and week 8. These assessments will include evaluations of symptoms, tear production, and eye health using similar tests as the initial assessment.
The primary focus will be on changes in symptoms and eye health from the baseline to week 8, as measured by the SANDE Global Score and other clinical tests.
Step 5
End of study
At the end of the study, the patient will undergo a final assessment to evaluate the overall impact of the treatment on dry eye symptoms and eye health.
The study aims to determine the efficacy and safety of the rhNGF eye drop solution in improving symptoms of dry eye disease.

Who can join the trial?

10 criteria

Must be a male or female aged 18 years or older, regardless of race, ethnicity, or eye color.
Must have been diagnosed with **dry eye disease** at least 6 months before joining the study. This includes current or recommended use of artificial tears for treatment.
Must have specific clinical features of **dry eye disease**:
- A score of 50 or higher on the **Symptoms Assessment in Dry Eye (SANDE)** questionnaire, which measures how dry your eyes feel.
- A result of more than 2 mm and less than 10 mm in 5 minutes on the **Schirmer-I test** without anesthesia. This test measures tear production.
- A **total corneal fluorescein staining grade** of 3 or higher, or a **total conjunctival lissamine green staining score** of 3 or higher. These tests check for damage or dryness on the eye's surface.
- A **fluorescein tear film break-up time (fTBUT)** of less than 10 seconds. This measures how quickly tears evaporate from the eye.
- Must have a **best corrected distance visual acuity (BCDVA)** score of 0.1 decimal units or better in each eye. This measures how well you can see with glasses or contact lenses.
- Females who can have children must have a negative pregnancy test.
- Must agree to all informed consent requirements, which means reading, signing, and dating the consent form before any study procedures. This form must be approved by the Institutional Review Board (IRB).
- Must be able and willing to follow the study procedures.

Who cannot join the trial?

8 criteria

Patients who have any other eye condition that could interfere with the study results.
Patients who have had eye surgery in the last 6 months.
Patients who are currently using other eye medications that might affect the study.
Patients with a history of allergies to any of the ingredients in the study medication.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial in the last 30 days.
Patients with any serious health condition that might make it unsafe for them to participate.
Patients who are unable to follow the study instructions or attend the required visits.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

A.O.U. Policlinico G. Martino Di Messina
Verified
Messina, Italy
Multimedica S.p.A.
Verified
Milan, Italy
Universita Degli Studi Di Roma La Sapienza
Responsive
Rome, Italy

Trial locations

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Investigated drugs

Recombinant Human Nerve Growth Factor (rhNGF) Eye Drop Solution is a new formulation being tested in this clinical trial. It is designed to help improve symptoms in patients with dry eye disease. The eye drops contain a special protein that may help repair and protect the surface of the eye, potentially reducing discomfort and improving vision quality for those suffering from dry eye. The trial is evaluating the effectiveness and safety of this treatment to see if it can provide better relief than existing options.

What is already known about the treatment

Recombinant Human Nerve Growth Factor (rhNGF) Eye Drop Solution – This medication is administered as eye drops and is currently being studied in clinical trials for its effectiveness in treating dry eye disease. It is in the experimental phase, with ongoing research to establish its safety and efficacy. The main therapeutic indication is for the relief of symptoms associated with dry eye. At the molecular level, rhNGF works by promoting nerve growth and repair, which may help improve tear production and eye surface health. It is classified pharmacologically as a nerve growth factor.

Investigated diseases

Dry Eye – Dry Eye is a condition where the eyes do not produce enough tears or the tears evaporate too quickly, leading to dryness and irritation. It can cause symptoms such as a gritty sensation, burning, redness, and blurred vision. The condition may worsen in certain environments, such as windy or air-conditioned spaces. Over time, the lack of adequate lubrication can lead to inflammation and damage to the eye's surface. It is often a chronic issue that can fluctuate in severity. Factors like age, hormonal changes, and prolonged screen time can contribute to its development.