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NCT03502447 · ClinicalTrials.gov registry record · NA
Randomized Study of the Safety and Effectiveness of the TearCare System for the Signs and Symptoms of Dry Eye Disease
A NA study, sponsored by Sight Sciences.
- Terminated
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT03502447: Clinical Trial NA study, sponsored by Sight Sciences.
NCT03502447 is a NA study that was terminated before completion, run by Sight Sciences. The registered enrollment target is 14 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03502447, a NA study, was terminated before completion, sponsored by Sight Sciences.
- TERMINATED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
Study Summary
In this study, the TearCare System will be compared with standard-of-care warm compress treatment and lid massage in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease and that it is superior to a commonly prescribed, standard treatment of warm compress and lid massage. NOTE: All sites have been selected for this study.
Primary Outcome
The TBUT was evaluated by measuring the time to breakup of the tear film following a complete blink when viewed through the slit-lamp using a cobalt blue filter. The TBUT was recorded using a stopwatch for each eye as the average of 3 measurements at each visit. The change in TBUT was The difference between the mean baseline value and the mean Month 1 value. The TBUT for each eye for a subject was averaged. The mean change in TBUT is the Month 1 value minus the baseline value for each subject wh
Interventions
- DEVICE TearCare
- DEVICE Warm Compress and Lid Massage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-04-20 |
| Est. Completion | 2018-12-04 |
| Phase | NA |
Why NCT03502447 stopped before completion
NCT03502447 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which TearCare is the first listed.
NCT03502447 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03502447 about?
NCT03502447 is a clinical study titled "Randomized Study of the Safety and Effectiveness of the TearCare System for the Signs and Symptoms of Dry Eye Disease". In this study, the TearCare System will be compared with standard-of-care warm compress treatment and lid massage in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease and that it is sup...
What is the current status of trial NCT03502447?
This trial is currently terminated. It is a NA study. The enrollment target is 14 participants. The study started on 2018-04-20. Estimated completion is 2018-12-04.
What interventions are being tested in trial NCT03502447?
The interventions under investigation include: TearCare (DEVICE), Warm Compress and Lid Massage (DEVICE).
Who is sponsoring clinical trial NCT03502447?
This trial is sponsored by Sight Sciences, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03502447's enrollment target sits among peer trials
14 1909th of 2000 higher than 90 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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