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NCT00947661 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of SPARC0912 and Reference0912 in Open Angle Glaucoma or Ocular Hypertension

A Phase 3 study, sponsored by Sun Pharma Advanced Research Company Limited.

Completed
Registry status
Phase 3
Development phase
578
Enrollment target

NCT00947661 is a Phase 3 study that has completed, run by Sun Pharma Advanced Research Company Limited. The registered enrollment target is 578 participants.

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The verdict

NCT00947661, a Phase 3 study, has completed, sponsored by Sun Pharma Advanced Research Company Limited.

COMPLETED
Registry status
Phase 3
Development phase
578 participants
Enrollment target

Study Summary

A single-blind , 12-week, parallel group clinical study is planned to evaluate the efficacy and safety of SPARC0912 and Reference0912. SPARC0912 is an experimental drug having similar active ingredient but containing a different preservative as that in Reference0912. Patients with open angle glaucoma or ocular hypertension will be enrolled and randomly assigned to receive either product. One drop will be instilled to the study eye nightly at 8:00 PM.

Interventions

  • DRUG SPARC0912
  • DRUG Reference0912

Trial Details

FieldValue
Enrollment Target 578 participants
Start Date 2010-07
Est. Completion 2012-05
Phase Phase 3

What the Registry Record Tells You About NCT00947661

The ClinicalTrials.gov registry entry for NCT00947661 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 578 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sun Pharma Advanced Research Company Limited, which has 20 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which SPARC0912 is the first listed.

NCT00947661 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00947661 about?

NCT00947661 is a clinical study titled "Efficacy and Safety of SPARC0912 and Reference0912 in Open Angle Glaucoma or Ocular Hypertension". A single-blind , 12-week, parallel group clinical study is planned to evaluate the efficacy and safety of SPARC0912 and Reference0912. SPARC0912 is an experimental drug having similar active ingredient but containing a different preservative as that in Reference0912. Patients with open angle glaucom...

What is the current status of trial NCT00947661?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 578 participants. The study started on 2010-07. Estimated completion is 2012-05.

What interventions are being tested in trial NCT00947661?

The interventions under investigation include: SPARC0912 (DRUG), Reference0912 (DRUG).

Who is sponsoring clinical trial NCT00947661?

This trial is sponsored by Sun Pharma Advanced Research Company Limited, which has 20 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.