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NCT00884585 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis
A Phase 3 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 176
- Enrollment target
NCT00884585 is a Phase 3 study that has completed, run by Allergan. The registered enrollment target is 176 participants.
The verdict
NCT00884585, a Phase 3 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 176 participants
- Enrollment target
Study Summary
This study evaluates the efficacy and safety of Cyclosporine 0.010% eye drops in the treatment of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye). The study consists of a double-masked phase, and open-labeled phase, and an open-labeled maintenance phase. For the first 3 months of the study, patients will receive either masked Cyclosporine 0.010% eye drops or vehicle four times daily; for the next 6 months, patients may receive open-labeled Cyclosporine 0.010% eye drops four times daily. At month 9, patients who are in remission, will be re-randomized to receive either open-labeled Cyclosporine 0.010% eye drops four times daily or twice daily.
Interventions
- DRUG Cyclosporine Vehicle
- DRUG Cyclosporine 0.010%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2009-05 |
| Est. Completion | 2011-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00884585
The ClinicalTrials.gov registry entry for NCT00884585 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 176 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allergan, which has 314 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cyclosporine Vehicle is the first listed.
NCT00884585 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00884585 about?
NCT00884585 is a clinical study titled "Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis". This study evaluates the efficacy and safety of Cyclosporine 0.010% eye drops in the treatment of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye). The study consists of a double-masked phase, and open-labeled phase, and an open-labeled maintenance phase. For the first 3 mont...
What is the current status of trial NCT00884585?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 176 participants. The study started on 2009-05. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00884585?
The interventions under investigation include: Cyclosporine Vehicle (DRUG), Cyclosporine 0.010% (DRUG).
Who is sponsoring clinical trial NCT00884585?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
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