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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 is a Phase 3 study that has completed, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 917 participants.

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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.

Interventions

  • DRUG Dexamethasone
  • OTHER Vehicle
  • DRUG Azasite
  • DRUG ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)

Trial Details

FieldValue
Enrollment Target 917 participants
Start Date 2011-10
Est. Completion 2013-06
Phase Phase 3

What the Registry Record Tells You About NCT01408082

The ClinicalTrials.gov registry entry for NCT01408082 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 917 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sun Pharmaceutical Industries Limited, which has 38 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Dexamethasone is the first listed.

NCT01408082 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.