Trials / Completed
CompletedNCT00947661
Efficacy and Safety of SPARC0912 and Reference0912 in Open Angle Glaucoma or Ocular Hypertension
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 578 (actual)
- Sponsor
- Sun Pharma Advanced Research Company Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SPARC0912 | Eye drops, once daily, 12 weeks |
| DRUG | Reference0912 | Eye drops, once daily, 12 weeks |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2012-05-01
- Completion
- 2012-05-01
- First posted
- 2009-07-28
- Last updated
- 2021-03-09
- Results posted
- 2016-05-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00947661. Inclusion in this directory is not an endorsement.