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NCT00405457 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms
A Phase 4 study, sponsored by Innovative Medical.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
NCT00405457: Completed Phase 4 study, sponsored by Innovative Medical.
NCT00405457 is a Phase 4 study that has completed, run by Innovative Medical. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00405457, a Phase 4 study, has completed, sponsored by Innovative Medical.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
Study Summary
To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI) score and symptoms will be the same or lower than baseline after treatment in these patients. The patients will tolerate the combination of Restasis® and Optive® with a low incidence of clinical adverse events.
Interventions
- DRUG Restasis, Optive Tears
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2006-11 |
| Est. Completion | 2008-01 |
| Phase | Phase 4 |
What the finished NCT00405457 record still lists
NCT00405457 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Restasis, Optive Tears is the first listed.
NCT00405457 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00405457 about?
NCT00405457 is a clinical study titled "Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms". To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI) score and symptoms will be the same or lower than baseline after treatment in these patients. The patients will tolerat...
What is the current status of trial NCT00405457?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2006-11. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00405457?
The interventions under investigation include: Restasis, Optive Tears (DRUG).
Who is sponsoring clinical trial NCT00405457?
This trial is sponsored by Innovative Medical, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00405457's enrollment target sits among peer trials
50 1255th of 2000 higher than 678 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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