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NCT01319773 · ClinicalTrials.gov registry record · Phase 1

Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye

A Phase 1 study, sponsored by Allergan.

Completed
Registry status
Phase 1
Development phase
44
Enrollment target

NCT01319773 is a Phase 1 study that has completed, run by Allergan. The registered enrollment target is 44 participants.

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The verdict

NCT01319773, a Phase 1 study, has completed, sponsored by Allergan.

COMPLETED
Registry status
Phase 1
Development phase
44 participants
Enrollment target

Study Summary

This study will evaluate the safety, tolerability and pharmacokinetics of two formulations of cyclosporine ophthalmic emulsion in healthy adults (parallel-group phase). The parallel-group phase will be followed by a paired-eye phase which will evaluate the safety and tolerability of two formulations of cyclosporine ophthalmic emulsion compared with cyclosporine ophthalmic emulsion (RESTASIS®) in patients with dry eye.

Interventions

  • DRUG cyclosporine ophthalmic emulsion Formulation A
  • DRUG cyclosporine ophthalmic emulsion Formulation B
  • DRUG cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05%
  • DRUG cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05%
  • DRUG cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2010-11
Est. Completion 2011-01
Phase Phase 1

Sponsor

Allergan

314 total trials

What the Registry Record Tells You About NCT01319773

The ClinicalTrials.gov registry entry for NCT01319773 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 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 5 interventions - of which cyclosporine ophthalmic emulsion Formulation A is the first listed.

NCT01319773 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01319773 about?

NCT01319773 is a clinical study titled "Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye". This study will evaluate the safety, tolerability and pharmacokinetics of two formulations of cyclosporine ophthalmic emulsion in healthy adults (parallel-group phase). The parallel-group phase will be followed by a paired-eye phase which will evaluate the safety and tolerability of two formulations...

What is the current status of trial NCT01319773?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2010-11. Estimated completion is 2011-01.

What interventions are being tested in trial NCT01319773?

The interventions under investigation include: cyclosporine ophthalmic emulsion Formulation A (DRUG), cyclosporine ophthalmic emulsion Formulation B (DRUG), cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05% (DRUG), cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05% (DRUG), cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B (DRUG).

Who is sponsoring clinical trial NCT01319773?

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.