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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
578
Eye drops, once daily, 12 weeks
Eye drops, once daily, 12 weeks
SPARC study site
High Point, North Carolina, United States
Change in Intraocular Pressure From Baseline to Week 12
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)
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.