Udonitrectag Eye Drops for Neurotrophic Keratitis

Recruiting at 43 trial locations

Overseen By Céline Plisson, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Recordati Rare Diseases

Must not be taking: Oxervate

Disqualifiers: Ocular cancer, Uncontrolled glaucoma, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

108 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called REC 0/0559 for adults with an eye condition called Neurotrophic Keratitis. The study aims to see if this treatment can help improve eye health, ensure it is safe, and understand how it works in the body. The trial is being conducted in Europe and the United States.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use other topical eye treatments during the study, except for certain allowed treatments like preservative-free artificial tears or specific glaucoma medications.

What data supports the effectiveness of the drug Udonitrectag Eye Drops for treating Neurotrophic Keratitis?

The review of dry eye disease treatments suggests that the vehicle used in eye drop formulations can have beneficial effects on eye conditions, which might imply potential benefits for Udonitrectag Eye Drops as well. ^{1 2 3 4 5}

Is Udonitrectag Eye Drops safe for use in humans?

In a study comparing a new ophthalmic drug delivery system (NODS) to another eye drop, 30 healthy volunteers reported some irritation with NODS, but no serious adverse effects were noted. This suggests that while there may be some discomfort, the treatment is generally safe for use in humans. ^{5 6 7 8 9}

How is Udonitrectag different from other drugs for neurotrophic keratitis?

Udonitrectag eye drops are unique because they may use a vehicle similar to cationic emulsion-based artificial tears, which have anti-inflammatory and wound-healing properties, potentially offering benefits beyond standard treatments for neurotrophic keratitis. ^{1 5 8 10 11}

Eligibility Criteria

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.

Inclusion Criteria

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.

Have a BCDVA score ≤ 75 ETDRS letters in the study eye, due to NK.

Exclusion 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).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive REC 0/0559 eye drops at varying doses for the treatment of Neurotrophic Keratitis

8 weeks

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Udonitrectag
• Vehicle

Trial Overview 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.

Participant Groups

Group I: Dose 3 - 5 µg/day Experimental Treatment 2 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/day Experimental Treatment 2 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/day Experimental Treatment 2 Interventions

Dose of study drug per day: 0.5 µg/day Study drug concentration: 5 µg/mL MT8 given 1 drop QID

Group IV: Vehicle Placebo Group 1 Intervention

Dose of study drug per day: 0 µg/day Study drug concentration: Vehicle given 1 drop QID

Who Is Running the Clinical Trial?

Recordati Rare Diseases

Lead Sponsor

Trials

14

Recruited

540+

Syneos Health

Collaborator

Trials

181

Recruited

69,600+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Preservative-free diclofenac sodium 0.1% for vernal keratoconjunctivitis. [2019]

2. England pubmed.ncbi.nlm.nih.gov

A Comprehensive Review of the Clinical Trials Conducted for Dry Eye Disease and the Impact of the Vehicle Comparators in These Trials. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Low-dose (0.01%) atropine eye-drops to reduce progression of myopia in children: a multicentre placebo-controlled randomised trial in the UK (CHAMP-UK)-study protocol. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Long-lasting otic medications may be a rare cause of neurogenic keratoconjunctivitis sicca in dogs. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

[Local treatment with diclofenac-Na eyedrops in diseases of the anterior eye segment]. [2013]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The ocular tolerability of a new ophthalmic drug delivery system (NODS). [2019]

7. England pubmed.ncbi.nlm.nih.gov

Revisiting Ocular Allergy: Evaluating Symptoms, Benzalkonium Chloride and Efficacy of Topical Ketotifen 0.025. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Determining initial ocular comfort differences between 0.7% olopatadine and 0.035% ketotifen fumarate. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of single- and multiple-dose ketotifen fumarate 0.025% ophthalmic solution in a pediatric population. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Anti-inflammatory activity of CKC-containing cationic emulsion eye drop vehicles. [2018]

11. Japan pubmed.ncbi.nlm.nih.gov

A quantitative tear fluids determination of therapeutic efficacy for allergic conjunctivitis. [2013]