Safety and Efficacy of T-2345 Compared to Xalatan in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
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.
Primary Open Angle Glaucoma
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Intraocular pressure [ Time Frame: 84 days ] [ Designated as safety issue: No ]Evaluation of intraocular pressure using Goldmann applanation tonometry.
- Visual Acuity [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]Corrected Snellen Visual Acuity measurement will be performed at all study visits with the Snellen eye chart using the subject's current corrective lens prescription at a distance equivalent to 20 feet (6 meters)
- Slit Lamp Examination [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]A routine slit lamp examination will be performed in at all study visits to evaluate the anterior segment of the eye, including lids, cornea, conjunctiva, anterior chamber, iris, and lens
- Ophthalmoscopy [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]Direct ophthalmoscopy with dilation will include assessment of the optic nerve head for pallor and cupping. A dilated fundus examination consisting of the vitreous, optic nerve, macula, and peripheral retina will be conducted.
- Visual Field Testing [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]The 30-2 or 24-2 test will be performed using an automated perimeter
- Safety [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]Adverse events, ocular comfort and tolerability will be assessed throughout the study
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
T-2345 Ophthalmic Solution dosed 1 drop QD in the eye(s) in the evening (8 pm +/- 30 minutes)
T-2345 Ophthalmic Solution
Xalatan (Latanoprost 0.005% Ophthalmic Solution) dosed 1 drop QD in the eye(s) in the evening (8 pm +/- 30 minutes)
Xalatan (latanoprost 0.005% ophthalmic solution)
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.