A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle
Model scores of the 29,894 trials active now.
Model score 8% 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 9% of the time (336 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2018-04-29, after 2018-04-07 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 2018-04-29. 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
-
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: oculareyebe willingassociatedtreatment of
Phrases that lowered it: allergenallergicsingletrialpositive skin -
Drug's FAERS reports marked serious: 32.5% (lowers risk) · Drug's FDA history
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Phase: 3 (lowers risk) · Design
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Sponsor's past termination rate: 6.1% (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 2.7% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Number of arms: 3 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 147 (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 5 (raises risk) · Sponsor's track record
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Blinding: double (raises risk) · Design
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Collaborators: 1 (raises risk) · Design
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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
- 3 (typical: 2)
- Number of arms
- 3 (typical: 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
- 147 (typical: 32)
- Sponsor's past termination rate
- 6.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 5 (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
- 2132 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 554 (typical: 412.5)
- Drug's FAERS reports marked serious
- 32.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 2.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- immunology
- Drugs matched to FDA substances
- ketotifen
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 Single Center Study for the Treatment of Moderate to Severe Allergic Conjunctivitis (EBI-005-AC-1) NCT02082899 · started 2014 · scored riskier than 9% of active trials completed
- Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model NCT01479374 · started 2012 · scored riskier than 13% of active trials completed
- A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model. NCT03479307 · started 2018 · scored riskier than 8% of active trials completed
- A Study of ADX-102 in Subjects With Allergic Conjunctivitis NCT03012165 · started 2016 · scored riskier than 9% of active trials completed
- Safety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for Allergic Conjunctivitis NCT02079649 · started 2014 · scored riskier than 15% 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.