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NCT04918823 · ClinicalTrials.gov registry record · Phase 1
Novel Use of Cyclosporine Ophthalmic Emulsion 0.05% in a PROSE Device
A Phase 1 study, sponsored by Boston Sight.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT04918823: Completed Phase 1 study, sponsored by Boston Sight.
NCT04918823 is a Phase 1 study that has completed, run by Boston Sight. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04918823, a Phase 1 study, has completed, sponsored by Boston Sight.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The goal of this prospective observational pilot study is to evaluate the tolerability and safety of RESTASIS (cyclosporine ophthalmic solution 0.05%) when added to the PROSE (Prosthetic Replacement of the Ocular Surface Ecosystem) lens reservoir in patients with ocular surface disease (OSD). Secondary endpoints include early (1-month) efficacy data for ocular signs and symptoms.
Primary Outcome
The Ocular Surface Disease Index (OSDI) is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.
Interventions
- DRUG Restasis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-07-15 |
| Est. Completion | 2023-04-14 |
| Phase | Phase 1 |
What the finished NCT04918823 record still lists
NCT04918823 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Restasis is the first listed.
NCT04918823 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04918823 about?
NCT04918823 is a clinical study titled "Novel Use of Cyclosporine Ophthalmic Emulsion 0.05% in a PROSE Device". The goal of this prospective observational pilot study is to evaluate the tolerability and safety of RESTASIS (cyclosporine ophthalmic solution 0.05%) when added to the PROSE (Prosthetic Replacement of the Ocular Surface Ecosystem) lens reservoir in patients with ocular surface disease (OSD). Second...
What is the current status of trial NCT04918823?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2021-07-15. Estimated completion is 2023-04-14.
What interventions are being tested in trial NCT04918823?
The interventions under investigation include: Restasis (DRUG).
Who is sponsoring clinical trial NCT04918823?
This trial is sponsored by Boston Sight, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04918823's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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