CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 578 enrolled
Drug / intervention
SPARC0912 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00947661
NCT00947661Phase 3Completed
CompareCT.gov

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

Sun Pharma Advanced Research Company Limited·interventional·Posted Jul 28, 2009·Updated Mar 9, 2021

In Brief

A Phase 3 clinical trial evaluating SPARC0912 and Reference0912 for Open Angle Glaucoma and Ocular Hypertension. Completed, enrolled 578 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpen Angle Glaucoma, Ocular Hypertension
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 28, 2009
Enrollment StartJul 1, 2010
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.9 years ago

Interventions

SPARC0912drug

Eye drops, once daily, 12 weeks

Reference0912drug

Eye drops, once daily, 12 weeks