A Safety and Efficacy Study of 2 Dosing Regimens of Recombinant Human Nerve Growth Factor (rhNGF) Eye Drop Solution Compared With Vehicle in Patients With Dry Eye Disease.
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (1,304 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-12-04, after 2024-01-22 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-12-04. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: newscorediseasepatientsenrollment
Phrases that lowered it: to evaluateevaluate theparticipantparticipantsvehicle -
Sponsor's past termination rate: 17.9% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports with a death: 2.1% (lowers risk) · Drug's FDA history
-
Drug's FAERS reports marked serious: 13.5% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
-
Blinding: quadruple (lowers risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Disease area, neurology: No (lowers risk) · Disease area
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Sponsor's past trials: 39 (lowers risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
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Maximum age: not given (lowers risk) · Who can join
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 39 (typical: 32)
- Sponsor's past termination rate
- 17.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 6507 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2337 (typical: 412.5)
- Drug's FAERS reports marked serious
- 13.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- cenegermin
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- A Study to Evaluate Safety and Efficacy of rhNGF Eye Solution vs Vehicle in Patients With Moderate to Severe Dry Eye NCT03982368 · started 2019 · scored riskier than 15% of active trials completed
- An 8-week Study to Evaluate Safety and Efficacy of NGF Eye Drops Solution Versus Vehicle in Patients With Dry Eye NCT03019627 · started 2017 · scored riskier than 37% of active trials completed
- Safety and Efficacy of rhNGF Eye Drops at Different Doses in Patients With Dry Eye NCT02101281 · started 2014 · scored riskier than 16% of active trials completed
- A 8 Weeks Study to Evaluate Efficacy & Safety of rhNGF vs Vehicle in Patients After Cataract and Refractive Surgery NCT03035864 · started 2017 · scored riskier than 47% of active trials completed
- Study to Evaluate Safety and Efficacy of rhNGF Eye Drops Solution Versus Vehicle in Patients With Glaucoma NCT02855450 · started 2016 · scored riskier than 52% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.