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NCT02013791 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease
A Phase 2 study, sponsored by Allergan.
- Terminated
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT02013791: Clinical Trial Phase 2 study, sponsored by Allergan.
NCT02013791 is a Phase 2 study that was terminated before completion, run by Allergan. The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02013791, a Phase 2 study, was terminated before completion, sponsored by Allergan.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be studied in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will participate in Stage 2 of this study. This study was terminated and Stage 2 of the study was cancelled.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are
Interventions
- OTHER Sham
- DRUG Vehicle
- DRUG Cyclosporine New Ophthalmic Formulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2014-04-29 |
| Est. Completion | 2017-04-12 |
| Phase | Phase 2 |
Why NCT02013791 stopped before completion
NCT02013791 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 3 interventions - of which Sham is the first listed.
NCT02013791 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02013791 about?
NCT02013791 is a clinical study titled "Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease". This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be studied in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will participate in Stage 2 of this stud...
What is the current status of trial NCT02013791?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2014-04-29. Estimated completion is 2017-04-12.
What interventions are being tested in trial NCT02013791?
The interventions under investigation include: Sham (OTHER), Vehicle (DRUG), Cyclosporine New Ophthalmic Formulation (DRUG).
Who is sponsoring clinical trial NCT02013791?
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 NCT02013791's enrollment target sits among peer trials
55 1153rd of 2000 higher than 841 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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