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Growth Factor

Oxervate for Dry Eye Syndrome (NGF0221 Trial)

Phase 3
Waitlist Available
Research Sponsored by Dompé Farmaceutici S.p.A
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a confirmed diagnosis of Sjogren syndrome or other autoimmune disease known to induce Sjogren's DED
Patients with severe Sjogren's DED characterized by symptom assessment in dry eye (SANDE) questionnaire global score >25 mm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening day ( day 8) up to follow-up week 24 (day 168 +/-7days)
Awards & highlights

NGF0221 Trial Summary

This trial will test if the drug cenegermin can help improve symptoms of dry eye disease in patients who are already using the drug cyclosporine A.

Eligible Conditions
  • Dry Eye Syndrome

NGF0221 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with Sjogren syndrome or another autoimmune disease that can cause dry eye disease.
Select...
You have severe Sjogren's dry eye disease, as determined by a questionnaire that measures your dry eye symptoms.

NGF0221 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening day ( day 8) up to follow-up week 24 (day 168 +/-7days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening day ( day 8) up to follow-up week 24 (day 168 +/-7days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in SANDE global score
Schirmer I test (without anesthesia) >10mm/5min in the eligible eye
Secondary outcome measures
Conjunctiva
Change from baseline in SANDE scores for severity and frequency
Change from baseline in Schirmer I test (without anesthesia)
+4 more

NGF0221 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OxervateExperimental Treatment1 Intervention
Oxervate®, an ophthalmic solution containing cenegermin 20 mcg/mL, which is a recombinant human Nerve Growth Factor (rhNGF). in this arm one drop of cenegermin 20 mcg/mL will be instilled in both eyes TID for 28 consecutive days.
Group II: VehiclePlacebo Group1 Intervention
In this arm one drop of vehicle will be instilled in both eyes TID for 28 consecutive days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxervate
2022
Completed Phase 3
~90

Find a Location

Who is running the clinical trial?

Dompé Farmaceutici S.p.ALead Sponsor
49 Previous Clinical Trials
4,449 Total Patients Enrolled
Yureeda Qazi, MDStudy DirectorDompé Farmaceutici
Francesco Sergio, MDStudy DirectorDompé Farmaceutici
2 Previous Clinical Trials
431 Total Patients Enrolled

Media Library

Cenegermin (Oxervate) (Growth Factor) Clinical Trial Eligibility Overview. Trial Name: NCT05136170 — Phase 3
Dry Eye Syndrome Research Study Groups: Oxervate, Vehicle
Dry Eye Syndrome Clinical Trial 2023: Cenegermin (Oxervate) Highlights & Side Effects. Trial Name: NCT05136170 — Phase 3
Cenegermin (Oxervate) (Growth Factor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05136170 — Phase 3
Dry Eye Syndrome Patient Testimony for trial: Trial Name: NCT05136170 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other instances where Oxervate was trialed as a potential treatment?

"Currently, there are 2 active clinical trials researching Oxervate. Of those 2 trials, both are in Phase 3. Most of the studies are located in Garden City, New york; however, there are 23 research centres spread out across the globe."

Answered by AI

How can interested individuals sign up for this clinical trial?

"This study, which was posted on clinicaltrials.gov on 1/27/2022, is currently looking for participants."

Answered by AI

Does this experiment pave the way for others like it?

"There are currently 2 clinical trials being conducted in 10 cities across 2 nations. The first trial for Oxervate was in 2022 and it completed Phase 3 drug approval in that same year. The trial was sponsored by Dompé Farmaceutici S.p.A and had 104 participants. A total of 221 trials have been completed since then."

Answered by AI

Are there any known side effects to using Oxervate?

"We believe that Oxervate is reasonably safe, as it is a Phase 3 trial medication. This suggests that there is some evidence of its efficacy, as well as multiple rounds of data supporting its safety."

Answered by AI

In how many different locations is this trial taking place today?

"There are 6 sites enrolling patients, such as The Johns Hopkins University in Baltimore, Eye Consultants of Atlanta in Atlanta, TUSM - New England Eye Center/Tufts Medical Center in Boston, as well as 6 other locations."

Answered by AI

How many test subjects are participating in this trial?

"That is correct, the information available on clinicaltrials.gov does show that this particular clinical trial is looking for participants. The trial was first posted on 1/27/2022, and the most recent update was on 10/24/2022. They are looking to have a total of 80 participants at 6 different locations."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
New Jersey
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Lugene Eye Institute - Glendale Office
Eye Consultants of Atlanta
How many prior treatments have patients received?
0
3+

What questions have other patients asked about this trial?

Why did patients apply to this trial?

I am so worried about my dry eyes that it stresses me out. I have post-lasik dry eye/ corneal neuralgia. I am highly motivated to get symptom relief.
PatientReceived no prior treatments
~27 spots leftby Mar 2025