Safety and Comfort of AL-4943A Ophthalmic Solution
Model scores of the 29,894 trials active now.
Model score 3% 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 9% of the time (238 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2011-06-30, after 2011-04-30 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2011-06-30. 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: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: activeadequateevidence ofabnormality thatprotocol
Phrases that lowered it: crossoverand safetysafety ofto evaluateevaluate the -
Design: crossover (lowers risk) · Design
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Primary purpose: not given (lowers risk) · Design
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Phase: 1 (lowers risk) · Design
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Drug's FAERS reports marked serious: 49.6% (lowers risk) · Drug's FDA history
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Sponsor's past termination rate: 8.6% (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 4.7% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 97 (lowers risk) · Sponsor's track record
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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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Disease area, neurology: No (lowers risk) · Disease area
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Number of arms: 3 (lowers risk) · Design
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Sponsor's past trials: 162 (lowers risk) · Sponsor's track record
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Disease area, psychiatry: No (lowers risk) · Disease area
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Maximum age: not given (lowers risk) · Who can join
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Minimum age: 18 (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
- 1 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- not given (typical: treatment)
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 162 (typical: 32)
- Sponsor's past termination rate
- 8.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 97 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 550 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 158 (typical: 412.5)
- Drug's FAERS reports marked serious
- 49.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- immunology
- Drugs matched to FDA substances
- ketotifen, olopatadine
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 Six-Week Safety Study of an Investigational Ophthalmic Solution NCT01698814 · started 2012 · scored riskier than 6% of active trials completed
- An Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis NCT01037179 · started 2010 · scored riskier than 25% of active trials completed
- Olopatadine Hydrochloride Ophthalmic Solution Study in Chinese Subjects NCT02322216 · started 2014 · scored riskier than 12% of active trials completed
- A Double-Masked Comparison of FID 123320 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness NCT06444529 · started 2024 · scored riskier than 11% of active trials completed
- Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye NCT04268069 · started 2020 · scored riskier than 12% 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.