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NCT00128245 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca
A Phase 2 study of Keratoconjunctivitis Sicca, sponsored by Novartis.
- Completed
- Registry status
- Phase 2
- Development phase
- 440
- Enrollment target
- 1
- Study location
NCT00128245: Completed Phase 2 study of Keratoconjunctivitis Sicca, sponsored by Novartis.
NCT00128245 is a Phase 2 study of Keratoconjunctivitis Sicca that has completed, run by Novartis. The registered enrollment target is 440 participants, above the 134-participant average among 10 other Keratoconjunctivitis Sicca trials with a reported enrollment target (228% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00128245, a Phase 2 study of Keratoconjunctivitis Sicca, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 440 participants
- Enrollment target
- 1
- Study location
Study Summary
This study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%) ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca (KCS, dry eye syndrome) patients.
Conditions Studied
Interventions
- DRUG Vehicle
- DRUG Pimecrolimus
Study Locations (1)
New Jersey
- Novartis - East Hanover
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2004-09 |
| Est. Completion | 2006-12 |
| Phase | Phase 2 |
What the finished NCT00128245 record still lists
NCT00128245 is an interventional study that assigns participants to a tested intervention. The registered 440 participants enrollment target is mid-sized for trials with a published cap, above the 134-participant average among 10 other Keratoconjunctivitis Sicca trials with a reported enrollment target (228% higher).
The record links to 1 condition, with Keratoconjunctivitis Sicca appearing as the primary indexed condition, and to 2 interventions - of which Vehicle is the first listed.
NCT00128245 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT00128245 about?
NCT00128245 is a clinical study titled "Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca". This study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%) ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca (KCS, dry eye syndrome) patients.
What is the current status of trial NCT00128245?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 440 participants. The study started on 2004-09. Estimated completion is 2006-12.
What conditions does trial NCT00128245 study?
This clinical trial studies the following conditions: Keratoconjunctivitis Sicca.
What interventions are being tested in trial NCT00128245?
The interventions under investigation include: Vehicle (DRUG), Pimecrolimus (DRUG).
Who is sponsoring clinical trial NCT00128245?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00128245 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Keratoconjunctivitis Sicca
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00128245's enrollment target sits among peer trials
440 1st of 10 higher than 10 of 10 other Keratoconjunctivitis Sicca trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Keratoconjunctivitis Sicca 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.
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