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NCT01408082 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis
A Phase 3 study, sponsored by Sun Pharmaceutical Industries Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 917
- Enrollment target
NCT01408082: Completed Phase 3 study, sponsored by Sun Pharmaceutical Industries Limited.
NCT01408082 is a Phase 3 study that has completed, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 917 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01408082, a Phase 3 study, has completed, sponsored by Sun Pharmaceutical Industries Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 917 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the clinical efficacy and safety of ISV-502 compared to AzaSite® alone, Dexamethasone alone, and vehicle in the treatment of subjects with Non-bacterial Blepharitis.
Primary Outcome
The primary efficacy endpoint for the comparison of ISV-502 and AzaSite is complete clinical resolution of signs and symptoms at Day 15.
Interventions
- DRUG Dexamethasone
- OTHER Vehicle
- DRUG Azasite
- DRUG ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 917 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
What the finished NCT01408082 record still lists
NCT01408082 is an interventional study that assigns participants to a tested intervention. The registered 917 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% higher).
The record links to 0 conditions, and to 4 interventions - of which Dexamethasone is the first listed.
NCT01408082 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01408082 about?
NCT01408082 is a clinical study titled "Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis". The purpose of this study is to evaluate the clinical efficacy and safety of ISV-502 compared to AzaSite® alone, Dexamethasone alone, and vehicle in the treatment of subjects with Non-bacterial Blepharitis.
What is the current status of trial NCT01408082?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 917 participants. The study started on 2011-10. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01408082?
The interventions under investigation include: Dexamethasone (DRUG), Vehicle (OTHER), Azasite (DRUG), ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined) (DRUG).
Who is sponsoring clinical trial NCT01408082?
This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 38 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01408082's enrollment target sits among peer trials
917 347th of 2000 higher than 1,654 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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