An Exploratory Crossover Clinical Trial to Compare the Activity of Reproxalap and Lifitegrast in a Dry Eye Disease Chamber
Model scores of the 29,894 trials active now.
Model score 8% for any early termination, 1% 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 2021-10-25, after 2021-09-09 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 2021-10-25. 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
-
Design: crossover (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: in subjectssubjects withtolerabilitydoubleinability
Phrases that lowered it: crossovervisitsingleeyeocular -
Phase: 2 (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Blinding: quadruple (lowers risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports marked serious: 15.8% (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 1.3% (lowers risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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Sponsor's past trials: 15 (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 9 (raises risk) · Sponsor's track record
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Maximum age: 70 (raises 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
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 70 (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
- 15 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 9 (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
- 8668 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2103 (typical: 412.5)
- Drug's FAERS reports marked serious
- 15.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- lifitegrast
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 Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease NCT04735393 · started 2021 · scored riskier than 9% of active trials completed
- A Clinical Trial to Assess Subjects With Dry Eye Disease. NCT04971031 · started 2021 · scored riskier than 8% of active trials completed
- A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease NCT05424549 · started 2022 · scored riskier than 8% of active trials completed
- A Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease NCT06493604 · started 2024 · scored riskier than 7% of active trials completed
- A Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease NCT06389214 · started 2024 · scored riskier than 10% 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.