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Udonitrectag Eye Drops for Neurotrophic Keratitis
Phase 2
Recruiting
Research Sponsored by Recordati Rare Diseases
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet aesthesiometer) within the area of the PED or corneal ulcer and outside of the area of the defect in at least one corneal quadrant.
Be a male or female aged ≥18 years at the time of ICF signature.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 8
Awards & highlights
Study Summary
This trial is testing a new medication to see if it is effective and safe for treating Neurotrophic Keratitis in adults. The trial will be conducted in Europe and the United States.
Who is the study for?
Adults over 18 with moderate to severe Neurotrophic Keratitis (NK) in one eye, who haven't improved with standard treatments. They must have reduced corneal sensitivity and a specific level of vision impairment due to NK. Excluded are those allergic to study drugs, pregnant or nursing women, recent participants in other trials, unwilling to follow procedures, or with certain ocular conditions or surgeries.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of REC 0/0559 eye drops compared to a placebo (vehicle) for treating Neurotrophic Keratitis. It's a phase 2 study conducted across Europe and the USA that also looks at how the body processes the drug.See study design
What are the potential side effects?
Potential side effects may include local eye irritation or discomfort, allergic reactions if sensitive to ingredients in REC 0/0559, and possibly systemic effects although these are not specified here.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have reduced feeling in my cornea due to an injury or ulcer.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Corneal healing
Secondary outcome measures
Visual acuity
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose 3 - 5 µg/dayExperimental Treatment2 Interventions
Dose of study drug per day: 5 µg/day Study drug concentration: 50 µg/mL MT8 given 1 drop QID
Group II: Dose 2 - 2.5 µg/dayExperimental Treatment2 Interventions
Dose of study drug per day: 2.5 µg/day Study drug concentration: 25 µg/mL MT8 given 1 drop QID
Group III: Dose 1 - 0.5 µg/dayExperimental Treatment2 Interventions
Dose of study drug per day: 0.5 µg/day Study drug concentration: 5 µg/mL MT8 given 1 drop QID
Group IV: VehiclePlacebo Group1 Intervention
Dose of study drug per day: 0 µg/day Study drug concentration: Vehicle given 1 drop QID
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Who is running the clinical trial?
Recordati Rare DiseasesLead Sponsor
10 Previous Clinical Trials
359 Total Patients Enrolled
Syneos HealthOTHER
172 Previous Clinical Trials
68,346 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My eye has a severe ulcer or a hole in the back part of the cornea.I am currently pregnant, nursing, or planning to become pregnant.I use contact lenses for vision correction or treatment in my affected eye(s).You are allergic to any of the ingredients in the study drug or other medications used during the study.You have a history of heavy drinking or drug/solvent abuse.I had a corneal transplant in my study eye over 6 months ago for NK.I am willing to follow all study procedures and assessments.I am a male who can father children and agree to use condoms during and 4 weeks after the study.I had eye surgery less than 3 months ago, unless it caused my Stage 2 or 3 NK.I have a moderate to severe eye condition in one eye that has lasted at least 2 weeks.My eye condition hasn't improved in 2 weeks despite using treatments like eye drops or antibiotics.I have an eye condition treated with preservative-free drops, not affecting my study participation.My glaucoma is not controlled, or I use eye drops more than once a day.I don't have any eye or serious health issues that could affect the study.I have been treated with Oxervate™ before.I've had eye surgery for NK, but not AMT, and it's been weeks since.I use certain eye drops that are not part of the study's treatment.I have reduced feeling in my cornea due to an injury or ulcer.I may need or already have tear duct plugs during the study.I am 18 years old or older.My condition is Stage 2 or 3 NK or has perforation.I do not have any active eye infections or inflammation unrelated to NK in my study eye.I am not using strong birth control methods.I have had eye cancer in the past.You have severe vision loss in the eye being studied, and the doctor doesn't think the treatment will improve it.I have severe eyelid inflammation or severe gland issues in my eye.
Research Study Groups:
This trial has the following groups:- Group 1: Dose 3 - 5 µg/day
- Group 2: Dose 1 - 0.5 µg/day
- Group 3: Vehicle
- Group 4: Dose 2 - 2.5 µg/day
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the quota of participants for this clinical investigation?
"Affirmative, clinicaltrials.gov has data indicating that this medical study is currently recruiting participants. Initially posted on October 13th 2020 and last modified on October 4th 2022, the trial needs to enlist 108 individuals from 5 distinct sites."
Answered by AI
Is the enrollment period for this clinical trial still in progress?
"Affirmative. According to the clinicaltrials.gov repository, this medical trial is presently seeking participants and was originally published on October 13th 2020 with a recent update dated October 4th 2022. The study necessitates 108 patients from 5 different clinics."
Answered by AI
Has the Food & Drug Administration sanctioned Udonitrectag?
"Due to the lack of evidence on Udonitrectag's efficacy, our team assigned it a safety rating of 2 out of 3. Although there is some data supporting its security, further clinical trials need to be done in order for it to receive a maximum score."
Answered by AI
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