NCT02059278

Safety and Efficacy of T-2345 Compared to Xalatan in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

A Randomized, Multicenter, Parallel-Group, Observer-Masked, Phase 3 Study to Compare the Safety and Efficacy of T-2345 Ophthalmic Solution to Xalatan (Latanoprost 0.005%) in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 335 (actual)
• Sponsor: Nephron Pharmaceuticals Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3 study to evaluate the safety and efficacy of T-2345 dosed to one of both eyes once daily for 84 days compared to Xalatan dosed to one of both eyes once daily for 84 days in patients with elevated eye pressure.

Detailed description

The objective of this Phase 3 study is to evaluate the efficacy and safety of T-2345 nonpreserved ophthalmic solution (latanoprost 0.005%) in comparison to Xalatan® (latanoprost 0.005%) in subjects with primary open angle glaucoma (POAG) or ocular hypertension (OH). This will be a randomized, multicenter, parallel-group, observer-masked study in approximately 380 evaluable subjects treated for 84 days. Subjects will have a history of POAG or OH and elevated intraocular pressure (IOP) and will have been adequately controlled (IOP ≤ 18 mm Hg) on latanoprost 0.005% ophthalmic solution monotherapy for at least 4 weeks. Primary efficacy (IOP) will be assessed in the study eye at each visit by Goldmann applanation tonometry at all assessment visits. Safety will be assessed at each visit by corrected Snellen Visual Acuity, slit lamp examination/anterior chamber cell count and flare and adverse event (AE) collection. Primary Efficacy Endpoint is the between-group comparison of the mean IOP values at each time point at each of the Day 15, 42, and 84 visits. Secondary Efficacy Endpoints include: * Between-group comparison of the mean change from baseline in diurnal IOP measurements at all postbaseline visits. * Between-group comparison of the mean change from baseline in IOP measurements at all times points at Day 15, Day 42 and Day 84.

Conditions

• Primary Open Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	T-2345	T-2345 Ophthalmic Solution
DRUG	Xalatan	Xalatan (latanoprost 0.005% ophthalmic solution)

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-02-11
• Last updated: 2018-08-22
• Results posted: 2018-08-22

Locations

1 site across 1 country: United States