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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: Completed Phase 1 study, sponsored by Allergan.
NCT01319773 is a Phase 1 study that has completed, run by Allergan. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Concentration of cyclosporine measured in blood at Day 1 of the parallel-group phase (PGP). Blood samples were collected up to 3 hours post-dose and concentrations of cyclosporine were measured.
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
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-01 |
| Phase | Phase 1 |
What the finished NCT01319773 record still lists
NCT01319773 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclosporine ophthalmic emulsion Formulation A is the first listed.
NCT01319773 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01319773's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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