Trial Outcomes & Findings for Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Adults With OHT or POAG (NCT NCT02829996)

NCT ID: NCT02829996

Last Updated: 2018-02-15

Results Overview

Daily change from diurnal baseline in IOP

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

201 participants

Primary outcome timeframe

Two Months

Results posted on

2018-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Trabodenoson 6.0% / Latanoprost 0.005% QD trabodenoson 6.0% / latanoprost 0.005% Fixed-Dose Combination trabodenoson 6.0% / latanoprost 0.005% QD: Trabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.	Trabodenoson 3.0% / Latanoprost 0.005% QD trabodenoson 3.0% / latanoprost 0.005% Fixed-Dose Combination trabodenoson 3.0% / latanoprost 0.005% QD: Trabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.	Trabodenoson 6.0% / Latanoprost 0.0025% QD trabodenoson 6.0% / latanoprost 0.0025% Fixed-Dose Combination trabodenoson 6.0% / latanoprost 0.0025% QD: Trabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.	Latanoprost 0.005% QD latanoprost 0.005% ophthalmic solution latanoprost 0.005% QD: Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.	Latanoprost 0.0025% QD latanoprost 0.0025% ophthalmic solution latanoprost 0.0025% QD: Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
Overall Study STARTED	39	39	40	41	42
Overall Study COMPLETED	38	39	40	41	42
Overall Study NOT COMPLETED	1	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Trabodenoson 6.0% / Latanoprost 0.005% QD trabodenoson 6.0% / latanoprost 0.005% Fixed-Dose Combination trabodenoson 6.0% / latanoprost 0.005% QD: Trabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.	Trabodenoson 3.0% / Latanoprost 0.005% QD trabodenoson 3.0% / latanoprost 0.005% Fixed-Dose Combination trabodenoson 3.0% / latanoprost 0.005% QD: Trabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.	Trabodenoson 6.0% / Latanoprost 0.0025% QD trabodenoson 6.0% / latanoprost 0.0025% Fixed-Dose Combination trabodenoson 6.0% / latanoprost 0.0025% QD: Trabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.	Latanoprost 0.005% QD latanoprost 0.005% ophthalmic solution latanoprost 0.005% QD: Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.	Latanoprost 0.0025% QD latanoprost 0.0025% ophthalmic solution latanoprost 0.0025% QD: Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
Overall Study Withdrawal by Subject	1	0	0	0	0

Baseline Characteristics

Study of Fixed-Dose Combinations of Trabodenoson and Latanoprost in Adults With OHT or POAG

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trabodenoson 6.0% / Latanoprost 0.005% QD n=39 Participants trabodenoson 6.0% / latanoprost 0.005% Fixed-Dose Combination trabodenoson 6.0% / latanoprost 0.005% QD: Trabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.	Trabodenoson 3.0% / Latanoprost 0.005% QD n=39 Participants trabodenoson 3.0% / latanoprost 0.005% Fixed-Dose Combination trabodenoson 3.0% / latanoprost 0.005% QD: Trabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.	Trabodenoson 6.0% / Latanoprost 0.0025% QD n=40 Participants trabodenoson 6.0% / latanoprost 0.0025% Fixed-Dose Combination trabodenoson 6.0% / latanoprost 0.0025% QD: Trabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.	Latanoprost 0.005% QD n=41 Participants latanoprost 0.005% ophthalmic solution latanoprost 0.005% QD: Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.	Latanoprost 0.0025% QD n=42 Participants latanoprost 0.0025% ophthalmic solution latanoprost 0.0025% QD: Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.	Total n=201 Participants Total of all reporting groups
Age, Continuous	64.1 years STANDARD_DEVIATION 12.08 • n=5 Participants	64.4 years STANDARD_DEVIATION 9.18 • n=7 Participants	68.8 years STANDARD_DEVIATION 8.43 • n=5 Participants	66.5 years STANDARD_DEVIATION 9.84 • n=4 Participants	66.4 years STANDARD_DEVIATION 8.57 • n=21 Participants	66.0 years STANDARD_DEVIATION 9.74 • n=10 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	23 Participants n=7 Participants	19 Participants n=5 Participants	22 Participants n=4 Participants	27 Participants n=21 Participants	108 Participants n=10 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	16 Participants n=7 Participants	21 Participants n=5 Participants	19 Participants n=4 Participants	15 Participants n=21 Participants	93 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants	10 Participants n=21 Participants	44 Participants n=10 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	27 Participants n=7 Participants	31 Participants n=5 Participants	32 Participants n=4 Participants	32 Participants n=21 Participants	152 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Region of Enrollment United States	39 participants n=5 Participants	39 participants n=7 Participants	40 participants n=5 Participants	41 participants n=4 Participants	42 participants n=21 Participants	201 participants n=10 Participants
Baseline IOP	27.67 mm of mercury STANDARD_DEVIATION 2.329 • n=5 Participants	27.17 mm of mercury STANDARD_DEVIATION 2.278 • n=7 Participants	27.28 mm of mercury STANDARD_DEVIATION 2.155 • n=5 Participants	27.48 mm of mercury STANDARD_DEVIATION 2.627 • n=4 Participants	27.31 mm of mercury STANDARD_DEVIATION 2.276 • n=21 Participants	27.38 mm of mercury STANDARD_DEVIATION 2.323 • n=10 Participants

PRIMARY outcome

Timeframe: Two Months

Population: Intent to treat

Daily change from diurnal baseline in IOP

Outcome measures

Outcome measures
Measure	Trabodenoson 6.0% / Latanoprost 0.005% QD n=39 Participants trabodenoson 6.0% / latanoprost 0.005% Fixed-Dose Combination trabodenoson 6.0% / latanoprost 0.005% QD: Trabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.	Trabodenoson 3.0% / Latanoprost 0.005% QD n=39 Participants trabodenoson 3.0% / latanoprost 0.005% Fixed-Dose Combination trabodenoson 3.0% / latanoprost 0.005% QD: Trabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.	Trabodenoson 6.0% / Latanoprost 0.0025% QD n=40 Participants trabodenoson 6.0% / latanoprost 0.0025% Fixed-Dose Combination trabodenoson 6.0% / latanoprost 0.0025% QD: Trabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.	Latanoprost 0.005% QD n=41 Participants latanoprost 0.005% ophthalmic solution latanoprost 0.005% QD: Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.	Latanoprost 0.0025% QD n=42 Participants latanoprost 0.0025% ophthalmic solution latanoprost 0.0025% QD: Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
Mean Intraocular Pressure (IOP)	-6.4 mm of mercury Standard Error 0.48	-6.8 mm of mercury Standard Error 0.56	-6.4 mm of mercury Standard Error 0.56	-7.1 mm of mercury Standard Error 0.46	-5.9 mm of mercury Standard Error 0.53

OTHER_PRE_SPECIFIED outcome

Timeframe: Through Study Completion, up to 9 weeks.

Collection of safety parameters, including treatment emergent adverse events, laboratory assessments, to assess tolerability and safety.