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NCT04125134 · ClinicalTrials.gov registry record · Phase 4
Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests
A Phase 4 study, sponsored by Tufts Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 36
- Enrollment target
NCT04125134: Clinical Trial Phase 4 study, sponsored by Tufts Medical Center.
NCT04125134 is a Phase 4 study that was terminated before completion, run by Tufts Medical Center. The registered enrollment target is 36 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04125134, a Phase 4 study, was terminated before completion, sponsored by Tufts Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 36 participants
- Enrollment target
Study Summary
This is a single site, prospective, cross-sectional, controlled clinical study on a total of 66 subjects. The subjects are divided into two groups: Hypertonic Saline Non-Responders (33 subjects) and Hypertonic Saline Responders (33 subjects). After completion of questionnaires, the subjects will undergo Dry Eye Disease testing and functional nerve testing. Subjects who qualify will be dispensed 4 weeks of preservative free artificial tears and instructed to instill one drop into each eye twice daily. Subjects will return for a follow up visit 4 weeks later (± 4 days), during which subjects will complete the questionnaires again and the Dry Eye Disease tests and functional nerve tests will be repeated.
Primary Outcome
The SANDE questionnaire is a paper and pencil questionnaire consisting of two questions (1. severity of dry eye disease symptoms and 2. frequency of dry eye disease symptoms), which are answered on a continuous visual analogue scale. The severity response from visit 2 will be subtracted from that given in visit 1 to provide a subject change. The results of those in the hypertonic saline response group will be compared to those within the hypertonic non-response group.
Interventions
- DRUG Preservative-free Refresh Optive Advanced Lubricant Eye Drops
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-10-03 |
| Est. Completion | 2025-07-31 |
| Phase | Phase 4 |
Why NCT04125134 stopped before completion
NCT04125134 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Preservative-free Refresh Optive Advanced Lubricant Eye Drops is the first listed.
NCT04125134 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04125134 about?
NCT04125134 is a clinical study titled "Predicting the Success of Dry Eye Disease Interventions Using Clinical Tests". This is a single site, prospective, cross-sectional, controlled clinical study on a total of 66 subjects. The subjects are divided into two groups: Hypertonic Saline Non-Responders (33 subjects) and Hypertonic Saline Responders (33 subjects). After completion of questionnaires, the subjects will und...
What is the current status of trial NCT04125134?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2019-10-03. Estimated completion is 2025-07-31.
What interventions are being tested in trial NCT04125134?
The interventions under investigation include: Preservative-free Refresh Optive Advanced Lubricant Eye Drops (DRUG).
Who is sponsoring clinical trial NCT04125134?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04125134's enrollment target sits among peer trials
36 1490th of 2000 higher than 495 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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