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Growth Factor

Oxervate for Dry Eye Syndrome (NGF0121 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at weeks 4, 8, 12 and 16
Awards & highlights

NGF0121 Trial Summary

This trial is testing whether or not a certain medication can help improve symptoms of a disease that causes dryness in the eyes.

Eligible Conditions
  • Dry Eye Syndrome

NGF0121 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at weeks 4, 8, 12 and 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and at weeks 4, 8, 12 and 16 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 Symptoms questionnaire (SANDE) global score
Schirmer I test (without anesthesia) >10mm/5min
Secondary outcome measures
Conjunctiva
Change from baseline in Schirmer I test (without anesthesia)
Change from baseline in Symptoms questionnaire (SANDE) scores for severity and frequency
+3 more

NGF0121 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OxervateExperimental Treatment1 Intervention
one drop of cenegermin 20 mcg/mL will be instilled in both eyes three times daily.
Group II: VehiclePlacebo Group1 Intervention
vehicle eye one drop will be instilled in both eyes three times daily.
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
4,430 Total Patients Enrolled
Francesco Sergio, MDStudy DirectorDompé Farmaceutici
2 Previous Clinical Trials
412 Total Patients Enrolled

Frequently Asked Questions

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

What is the total pool size for this research?

"As of 10/24/2022, this particular clinical trial is no longer recruiting patients. But, there are other active trials (e.g. 150 for eye diseases) that might be of interest."

Answered by AI

Will people experience any side effects from using Oxervate?

"Oxervate safety was given a 3 because there is some evidence of efficacy in Phase 3 trials as well as multiple rounds of data supporting its safety."

Answered by AI

Is there a precedent for using Oxervate in this way?

"Originally, OCLI (Ophthalmic Consultants of Long Island) conducted the first study on Oxervate in 2022. As of now, there have been 221 completed clinical trials and 2 studies are still recruiting patients. The majority of these trials take place in Glendale, California."

Answered by AI

What other types of research does this study compare to?

"There are 2 ongoing clinical trials testing Oxervate in 10 cities and 2 nations. The first study began in the year 2022 and was completed by Dompé Farmaceutici S.p.A. A total of 221 have been conducted since then."

Answered by AI

At how many different sites is this research being conducted?

"There are 11 locations in total where this trial is accepting patients. A few of these sites include Lugene Eye Institute - Glendale Office in Glendale, California, The Johns Hopkins University in Baltimore, Maryland, and David Wirta, M.D. & Associates in Newport Beach, Tennessee."

Answered by AI

Is there still room for more people in this clinical trial?

"Unfortunately, this study is no longer recruiting patients. The trial was initially posted on January 14th, 2022 but the most recent edit was made on October 24th, 2022. However, there are still numerous active trials in both eye disease and Oxervate with a combined total of over 150 open studies."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
How old are they?
18 - 65
What site did they apply to?
The Johns Hopkins University
Virginia Eye Consultants (VEC) - Norfolk Office
David Wirta, M.D. & Associates
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (NGF0121 - PROTEGO-1 Study)
2022. "Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (NGF0121 - PROTEGO-1 Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05133180.
All > Dry Eye
~32 spots leftby Apr 2025
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