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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 is a Phase 4 study that has completed, run by Innovative Medical. The registered enrollment target is 50 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00405457
The ClinicalTrials.gov registry entry for NCT00405457 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Innovative Medical, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Restasis, Optive Tears is the first listed.
NCT00405457 reports 0 study locations.
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.
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