Trial Outcomes & Findings for Efficacy of Changing to TRAVATAN® From Prior Therapy (NCT NCT01510145)

Results Overview

IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

191 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2014-06-13

Participant Flow

Patients were recruited from 4 study centers located in Argentina, 4 study centers located in Chile, and 2 study centers located in Colombia.

This reporting group includes all enrolled patients (191).

Participant milestones

Participant milestones
Measure	TRAVATAN® BAK-free Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
Overall Study STARTED	191
Overall Study COMPLETED	173
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	TRAVATAN® BAK-free Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
Overall Study Adverse Event	6
Overall Study Lost to Follow-up	5
Overall Study Withdrawal by Subject	6
Overall Study Relative reported subject withdrew	1

Baseline Characteristics

Efficacy of Changing to TRAVATAN® From Prior Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TRAVATAN® BAK-free n=191 Participants Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
Age, Continuous	67.5 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	139 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: This analysis population includes all patients who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit.

IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.

Outcome measures

Outcome measures
Measure	TRAVATAN® BAK-free n=191 Participants Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline) Baseline	14.8 mmHg Standard Deviation 3.4
Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline) Change from baseline at Week 12	-1.09 mmHg Standard Deviation 2.96

SECONDARY outcome

Timeframe: Week 12

Population: This anaylysis population includes all subjects who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit.

IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.

Outcome measures

Outcome measures
Measure	TRAVATAN® BAK-free n=191 Participants Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
Percentage of Subjects Who Reach Target IOP (≤18 mmHg)	93.3 percentage of patients

Adverse Events

TRAVATAN® BAK-free

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

Doug Hubatsch, Global Brand Leader, Medical Affairs

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