An Evaluation of AZR-MD-001 as Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD)
Model scores of the 29,894 trials active now.
Model score 12% for any early termination, 3% 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 2020-12-11, after 2019-10-04 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 2020-12-11. 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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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: longmonthsor disorderscoretherapy
Phrases that lowered it: evaluate theto evaluatehypertensionvehicleocular -
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Number of arms: 2 (raises risk) · Design
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Blinding: double (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
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Collaborators: 1 (raises risk) · Design
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- none matched
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
- Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD) NCT04391959 · started 2020 · scored riskier than 14% of active trials completed
- A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED) NCT03652051 · started 2018 · scored riskier than 14% of active trials completed
- Methods to Enhance AZR-MD-001 for Meibomian Gland Dysfunction (MGD) NCT04314362 · started 2020 · scored riskier than 19% of active trials completed
- Safety, Tolerability and Pharmacodynamics of AZR-MD-001 in Contact Lens Discomfort (CLD) NCT05548491 · started 2022 · scored riskier than 12% of active trials completed
- Safety, Efficacy and Pharmacokinetics of CBT-006 in Patients With Meibomian Gland Dysfunction NCT04884243 · started 2021 · scored riskier than 14% 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.