A Study to Evaluate the Long Term Safety of OTX-TP (Sustained Release Travoprost) Intracanalicular Insert
Model scores of the 29,894 trials active now.
Model score 13% 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 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
Completed on 2020-09-22, after 2018-07-10 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 2020-09-22. 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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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: termthe longsubjects withextension studysubject
Phrases that lowered it: trialsafety ofevaluate theto evaluatevisit -
Phase: 3 (lowers risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Design: single group (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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Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
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Disease area, cancer: 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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Disease area, neurology: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Number of arms: 1 (raises risk) · Design
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Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history
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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 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
- 12 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (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
- Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT NCT02914509 · started 2016 · scored riskier than 6% of active trials completed
- Phase 2b Study Evaluating Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular Hypertension NCT02312544 · started 2014 · scored riskier than 6% of active trials completed
- Multi-Arm Feasibility Study Evaluating OTX-TP Compared to Timolol in Treatment of Subjects With Open Angle Glaucoma NCT01845038 · started 2013 · scored riskier than 12% of active trials completed
- CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension NCT04360174 · started 2018 · scored riskier than 9% of active trials completed
- A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT) NCT05335122 · started 2022 · scored riskier than 7% 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.