Trial Outcomes & Findings for Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma (NCT NCT01995136)

Results Overview

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data at 9:00 AM from Weeks 4, 8, and 12 were pooled. A more negative change indicates a greater amount of improvement. One eye (study eye) was subject to analysis.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

32 participants

Primary outcome timeframe

Baseline (Day 0), Week 4, Week 8, Week 12

Results posted on

2015-10-07

Participant Flow

Subjects were recruited from 5 study sites located in Japan.

This reporting group includes all enrolled subjects (32).

Participant milestones

Participant milestones
Measure	TRAVATAN Z Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
Overall Study STARTED	32
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	TRAVATAN Z Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
Overall Study Change in residence	1

Baseline Characteristics

Investigation of Intraocular Pressure (IOP) Reduction Efficacy of Travoprost Ophthalmic Solution in Patients With Normal Tension Glaucoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TRAVATAN Z n=30 Participants Ophthalmic solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
Age, Continuous	65.6 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Baseline IOP 9:00 AM	16.55 mmHg STANDARD_DEVIATION 1.43 • n=5 Participants
Baseline IOP 1:00 PM	15.72 mmHg STANDARD_DEVIATION 1.82 • n=5 Participants
Baseline IOP 5:00 PM	15.73 mmHg STANDARD_DEVIATION 2.17 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0), Week 4, Week 8, Week 12

Population: This analysis population includes all enrolled subjects minus any subjects with all missing data and/or critical protocol deviation/s.

IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data at 9:00 AM from Weeks 4, 8, and 12 were pooled. A more negative change indicates a greater amount of improvement. One eye (study eye) was subject to analysis.

Outcome measures

Outcome measures
Measure	TRAVATAN Z n=30 Participants Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12 Baseline	16.55 mmHg Interval 15.88 to 17.22
Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12 Change from Baseline	-3.37 mmHg Interval -3.9 to -2.85

Adverse Events

TRAVATAN Z

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Manager, Phase IV

Alcon Japan, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER