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NCT01109056 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium
A Phase 2 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 2
- Development phase
- 115
- Enrollment target
NCT01109056: Completed Phase 2 study, sponsored by Allergan.
NCT01109056 is a Phase 2 study that has completed, run by Allergan. The registered enrollment target is 115 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01109056, a Phase 2 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 115 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) in patients with primary pterygium (abnormal growth on surface of eye).
Primary Outcome
Number of pterygium hyperemia responders at Week 16 as measured by the Pterygium Hyperemia Grading Scale. The Pterygium Hyperemia Grading Scale is a 6-point scale (0=absent, 1=trace, 2=mild, 3=moderate, 4=moderately severe, 5=severe). A responder is defined as a patient demonstrating at least a 2-grade decrease from baseline in pterygium hyperemia.
Interventions
- DRUG Vehicle
- DRUG cyclosporine ophthalmic emulsion 0.05%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
What the finished NCT01109056 record still lists
NCT01109056 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT01109056 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01109056 about?
NCT01109056 is a clinical study titled "Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium". This study will evaluate the safety and efficacy of Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) in patients with primary pterygium (abnormal growth on surface of eye).
What is the current status of trial NCT01109056?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 115 participants. The study started on 2010-06. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01109056?
The interventions under investigation include: Vehicle (DRUG), cyclosporine ophthalmic emulsion 0.05% (DRUG).
Who is sponsoring clinical trial NCT01109056?
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 NCT01109056's enrollment target sits among peer trials
115 626th of 2000 higher than 1,374 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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