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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: Completed Phase 3 study, sponsored by Allergan.
NCT00884585 is a Phase 3 study that has completed, run by Allergan. The registered enrollment target is 176 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Treatment responders are defined as patients with a ≥ 1 grade improvement from baseline in punctate corneal staining score and a ≥ 4 grade improvement from baseline in composite symptom score in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 (0 is ≤2 dots and 5 is \>316 dots (approximately) or ulcer/erosion). The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). The composite symptom score (0
Interventions
- DRUG Cyclosporine Vehicle
- DRUG Cyclosporine 0.010%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2009-05 |
| Est. Completion | 2011-07 |
| Phase | Phase 3 |
What the finished NCT00884585 record still lists
NCT00884585 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Cyclosporine Vehicle is the first listed.
NCT00884585 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00884585's enrollment target sits among peer trials
176 1438th of 2000 higher than 561 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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