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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: Completed Phase 3 study, sponsored by Sun Pharma Advanced Research Company Limited.
NCT00947661 is a Phase 3 study that has completed, run by Sun Pharma Advanced Research Company Limited. The registered enrollment target is 578 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
95% CI for the difference between treatment groups in estimated mean change from baseline was computed for each a total of 12 time points (for the reduction in intraocular pressure from baseline to Week 12)
Interventions
- DRUG SPARC0912
- DRUG Reference0912
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 578 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
What the finished NCT00947661 record still lists
NCT00947661 is an interventional study that assigns participants to a tested intervention. The registered 578 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 (25% lower).
The record links to 0 conditions, and to 2 interventions - of which SPARC0912 is the first listed.
NCT00947661 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00947661's enrollment target sits among peer trials
578 661st of 2000 higher than 1,340 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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