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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.

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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

FieldValue
Enrollment Target 176 participants
Start Date 2009-05
Est. Completion 2011-07
Phase Phase 3

Sponsor

Allergan

314 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.