Trial Outcomes & Findings for SYL040012, Treatment for Open Angle Glaucoma (NCT NCT02250612)

NCT ID: NCT02250612

Last Updated: 2021-01-06

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

184 participants

Primary outcome timeframe

Baseline and Day 28

Results posted on

2021-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	SYL040012 (Bamosiran) 0.375% Eye Drops 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) 0.375 %	SYL040012 (Bamosiran) 0.750 % Eye Drops 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) 0.750 %	SYL040012 (Bamosiran) 1.125% Eye Drops 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) 1.125%	SYL040012 (Bamosiran) 1.5% Eye Drops 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) 1.5%	Timolol Maleate 0.5% Ophthalmic Solution 1 drop in each eye twice daily for 28 consecutive days 1 drop of timolol maleate: 0.5 %
Overall Study STARTED	37	40	37	33	37
Overall Study COMPLETED	36	38	35	33	36
Overall Study NOT COMPLETED	1	2	2	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SYL040012, Treatment for Open Angle Glaucoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SYL040012 (Bamosiran) Eye Drops Dose A n=37 Participants 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) Dose A	SYL040012 (Bamosiran) Eye Drops Dose B n=40 Participants 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) Dose B	SYL040012 (Bamosiran) Eye Drops Dose C n=37 Participants 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) Dose C	SYL040012 (Bamosiran) Eye Drops Dose D n=33 Participants 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) Dose D	Timolol Maleate 0.5% Ophthalmic Solution n=37 Participants 1 drop in each eye twice daily for 28 consecutive days 1 drop of timolol maleate: 0.5 %	Total n=184 Participants Total of all reporting groups
Age, Continuous	60.7 years STANDARD_DEVIATION 10.4 • n=5 Participants	59.4 years STANDARD_DEVIATION 12.9 • n=7 Participants	61.5 years STANDARD_DEVIATION 10.1 • n=5 Participants	62.4 years STANDARD_DEVIATION 11.1 • n=4 Participants	60.2 years STANDARD_DEVIATION 11.5 • n=21 Participants	60.8 years STANDARD_DEVIATION 11.18 • n=8 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	24 Participants n=7 Participants	22 Participants n=5 Participants	24 Participants n=4 Participants	24 Participants n=21 Participants	119 Participants n=8 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	16 Participants n=7 Participants	15 Participants n=5 Participants	9 Participants n=4 Participants	13 Participants n=21 Participants	65 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline and Day 28

Outcome measures

Outcome measures
Measure	SYL040012 (Bamosiran) 0.375 % Eye Drops n=36 Participants 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) 0.375 %	SYL040012 (Bamosiran) 0.75 % Eye Drops n=38 Participants 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) 0.75%	SYL040012 (Bamosiran) 1.125% Eye Drops n=35 Participants 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) 1.125%	SYL040012 (Bamosiran) 1.5% Eye Drops n=33 Participants 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) 1.5%	Timolol Maleate 0.5% Ophthalmic Solution n=35 Participants 1 drop in each eye twice daily for 28 consecutive days 1 drop of timolol maleate: 0.5 %
Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm	-2.4 mmHg Standard Deviation 2.6	-3.2 mmHg Standard Deviation 3.9	-3.1 mmHg Standard Deviation 2.5	-3.1 mmHg Standard Deviation 3.2	-6.1 mmHg Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline and Day 14

Outcome measures

Outcome measures
Measure	SYL040012 (Bamosiran) 0.375 % Eye Drops n=36 Participants 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) 0.375 %	SYL040012 (Bamosiran) 0.75 % Eye Drops n=38 Participants 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) 0.75%	SYL040012 (Bamosiran) 1.125% Eye Drops n=35 Participants 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) 1.125%	SYL040012 (Bamosiran) 1.5% Eye Drops n=33 Participants 1 drop in each eye once daily for 28 consecutive days 1 drop of SYL040012 (bamosiran) 1.5%	Timolol Maleate 0.5% Ophthalmic Solution n=35 Participants 1 drop in each eye twice daily for 28 consecutive days 1 drop of timolol maleate: 0.5 %
Change From Baseline in the Mean Diurnal IOP Within Each Treatment Arm	-2.4 mmHg Standard Deviation 2.6	-2.9 mmHg Standard Deviation 2.4	-2.5 mmHg Standard Deviation 2.1	-2.4 mmHg Standard Deviation 3.1	-5.8 mmHg Standard Deviation 1.9

SECONDARY outcome

Timeframe: Baseline and Day 29

The GQL-15 is a 15 item, 4-domain tool. GQL-15 scoring ranges from 0 to 75. Higher scores indicate poorer quality of life.