Trial Outcomes & Findings for Efficacy of Changing to TRAVATAN® From Prior Therapy (NCT NCT01493427)

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

202 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2014-05-19

Participant Flow

Subjects were recruited from 15 investigative sites located in Europe: Belgium (2); Spain (6); Italy (4); Sweden (3).

Of the 202 subjects enrolled, 1 subject was exited as a screen failure and 2 subjects withdrew consent prior to dosing. This reporting group includes all subjects who instilled at least one dose of the test article (199).

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 Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative
Overall Study STARTED	199
Overall Study COMPLETED	179
Overall Study NOT COMPLETED	20

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 Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative
Overall Study Adverse Event	10
Overall Study Personal Reasons	4
Overall Study Lost to Follow-up	2
Overall Study Inability to Follow Instructions	2
Overall Study Other	2

Baseline Characteristics

Efficacy of Changing to TRAVATAN® From Prior Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TRAVATAN® BAK-free n=199 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 Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative
Age, Continuous	66.6 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	117 Participants n=5 Participants
Sex: Female, Male Male	82 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: The Full Analysis Set (FA) included 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 (N=187). Here, "n" is the number of participants with non-missing values at the specific time point.

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=187 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
Mean Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline) Change from Baseline at Week 12 (n=178)	-1.16 millimeters mercury (mmHg) Standard Deviation 2.65
Mean Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline) Baseline	17.0 millimeters mercury (mmHg) Standard Deviation 3.3

SECONDARY outcome

Timeframe: Week 12

Population: The Full Analysis Set (FA) included 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=187 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 Patients With Target IOP (≤18 mmHg) at 12 Weeks	81.2 Percentage of participants

Adverse Events

TRAVATAN® BAK-free

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TRAVATAN® BAK-free n=199 participants at risk Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative
Gastrointestinal disorders Upper gastrointestinal hemmorhage	0.50% 1/199 • Adverse event data were collected and reported in the eCRF at each visit from time of first drug instillation to Week 12. Adverse events were collected for the duration of the study (1 year, 2 months). This reporting group includes all subjects who instilled at least one dose of the test article.
Infections and infestations Pneumonia pneumococcal	0.50% 1/199 • Adverse event data were collected and reported in the eCRF at each visit from time of first drug instillation to Week 12. Adverse events were collected for the duration of the study (1 year, 2 months). This reporting group includes all subjects who instilled at least one dose of the test article.
Infections and infestations Respiratory tract infection	0.50% 1/199 • Adverse event data were collected and reported in the eCRF at each visit from time of first drug instillation to Week 12. Adverse events were collected for the duration of the study (1 year, 2 months). This reporting group includes all subjects who instilled at least one dose of the test article.
Hepatobiliary disorders Cholelithiasis	0.50% 1/199 • Adverse event data were collected and reported in the eCRF at each visit from time of first drug instillation to Week 12. Adverse events were collected for the duration of the study (1 year, 2 months). This reporting group includes all subjects who instilled at least one dose of the test article.

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