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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
335
Unnamed facility
El Paso, Texas, United States
Intraocular Pressure
Evaluation of intraocular pressure using Goldmann applanation tonometry. Primary outcome was the between group difference in the change from baseline in IOP at each of 9 assessment points. Equivalence was achieved if the 95% Confidence Intervals were within 1.5 mmHg at all 9 time points
Time frame: Measured at 8am 10 am and 4 pm at Baseline and on Days 15, 42 and 84
Visual Acuity
Visual Acuity was measured using the Corrected Snellen Visual Acuity method reported as the Logarithm Minimum Angle of Resoution (logMAR) change from baseline. The Snellen eye chart was used with the subject's current corrected lens prescription at a distance equivalent to 20 feet. Results from the Snellen chart were converted to the logMAR scale which is the standard tool for reporting visual acuity outcomes.
Time frame: Baseline and 84 days
Slit Lamp Examination
Number of participants with eye abnormalities following routine slit lamp examination. The anterior segment of the eye including lids, cornea, conjunctiva, anterior chamber, iris and lens were evaluated with a routine slit lamp examination and any abnormalities observed were reported.
Time frame: Baseline and 84 days
Ophthalmoscopy
Number of participants with eye abnormalities following ophthalmoscopy. Direct ophthalmoscopy with dilation included assessment of the optic nerve head for pallor and cupping. A dilated fundus examination consisting of the vitreous, optic nerve, macula, and peripheral retina was conducted. Results are reported as the number of subjects with clinical significant abnormalities at Day 84 that were not clinically significant at Baseline.
Time frame: Baseline and 84 days
Mean Deviation in Visual Field
Visual Field was performed using an automated perimeter according to the sites standard protocol. This test measures the angle of the visual field from the central visual axis. Visual Field Testing generates a numerical scale as its main result which shows the retinal sensitivities at the different test locations, expressed in Decibels (dB). The mean deviation in the visual field reflects the overall depression (deviation from normal values). Negative values indicate a reduction in visual field. The analysis performed is the mean change from baseline at Day 84.
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Time frame: Baseline and 84 days