Trial Outcomes & Findings for Safety and Efficacy of Changing to DuoTrav in Patients Uncontrolled on Timolol (NCT NCT01336569)

Results Overview

As measured by Goldmann applanation tonometry. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

Baseline, up to 6 weeks

Results posted on

2013-07-08

Participant Flow

Participants were recruited and enrolled from 4 study centers located in Brazil.

Of the 50 enrolled, 1 participant did not meet inclusion/exclusion criteria and was exited from the study prior to receiving study product. This reporting group includes all participants who received study product.

Participant milestones

Participant milestones
Measure	DuoTrav Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
Overall Study STARTED	49
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	DuoTrav Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
Overall Study Lost to Follow-up	4

Baseline Characteristics

Safety and Efficacy of Changing to DuoTrav in Patients Uncontrolled on Timolol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DuoTrav n=49 Participants Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
Age Continuous	63.3 years STANDARD_DEVIATION 10.6 • n=99 Participants
Sex: Female, Male Female	36 Participants n=99 Participants
Sex: Female, Male Male	13 Participants n=99 Participants
Region of Enrollment Brazil	49 participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline, up to 6 weeks

Population: Intent-to-Treat (ITT): All participants who received study medication and had at least one on-therapy study visit.

As measured by Goldmann applanation tonometry. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.

Outcome measures

Outcome measures
Measure	DuoTrav n=45 Participants Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy)	-5.0 millimeters mercury (mmHg) Standard Deviation 3.6

Adverse Events

DuoTrav

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DuoTrav n=49 participants at risk Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
Gastrointestinal disorders Enterorrhagia	2.0% 1/49 • Adverse events were collected for the duration of the study. This reporting group includes all participants who received study product.

Other adverse events

Adverse event data not reported

Additional Information

Doug Hubatsch, Global Brand Medical Affairs Leader, Glaucoma

Alcon Research, 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