A Phase 3 Study to Evaluate the Efficacy and Safety of Pimecrolimus 0.3% Ophthalmic Ointment
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 10% of the time (1,463 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2025-10-15, after 2024-04-22 start.
Reason given by the sponsor: “business”
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 2025-10-15. 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: subjects withophthalmiceyeto determinein subjects
Phrases that lowered it: and safetyefficacy andsafety ofthe efficacytopical -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 35.6% (lowers risk) · Drug's FDA history
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports with a death: 1.5% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Blinding: quadruple (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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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: 2 (raises risk) · Design
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
- 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
- 0 (typical: 1)
Who can join
- Minimum age
- 2 (typical: 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
- 0 (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
- 3130 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 766 (typical: 412.5)
- Drug's FAERS reports marked serious
- 35.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 1.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- pimecrolimus
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
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- Evaluating the Safety, Tolerability, and Efficacy of GRF312 5% in Participants With Dry Eye Disease (DED). NCT07264517 · started 2025 · scored riskier than 44% of active trials completed
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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.